Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma
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Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy also work in different ways to kill more cancer cells or stop them from growing. It is not yet known whether rituximab is more effective with combination chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing peripheral blood stem cell transplantation.
PURPOSE: This randomized phase II trial studies how well giving rituximab together with combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy and peripheral blood stem cell transplantation works in treating older patients with previously untreated mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: bendamustine hydrochloride Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: methotrexate Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial of R-HCVAD/MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant Vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients ≤ 65 Years of Age With Previously Untreated Mantle Cell Lymphoma |
- PFS at 2 years [ Designated as safety issue: No ]
- Toxicity of R-HCVAD/MTX/Ara-C and autologous stem cell transplant (ASCT) or R-bendamustine and ASCT [ Designated as safety issue: Yes ]
- Response rate in patients treated with these regimens [ Designated as safety issue: No ]
- Overall survival of patients treated with these regimens [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Course 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Course 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients then undergo stem cell collection after completion of course 2. Patients undergo stem cell collection after completion of course 2.
|
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given IV
Drug: dexamethasone
Given PO or IV
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given PO or IV
Drug: methotrexate
Given IV
Drug: vincristine sulfate
Given IV
|
|
Experimental: Arm II
Course 1-6: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks later, patients with responsive disease receive 2 additional courses of treatment. Beginning within 8 weeks, patients receive rituximab IV and cyclophosphamide IV over 1 hour on day 1. Patients then undergo stem cell collection about 26 days later.
|
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: cyclophosphamide
Given IV
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
All patients must have previously untreated stage III, IV, or bulky stage II mantle cell lymphoma (MCL)
A diagnosis of MCL must be confirmed by histopathological diagnosis including immunohistochemistry and flow cytometry documenting both of the following phenotypes:
- CD19+ or CD20+
- Cyclin D1+ or evidence of the t(11;14) translocation by cytogenetics or FISH
Adequate sections from the original diagnostic specimen must be available for submission for central review
An adequate biopsy requires sufficient tissue to establish the architecture and a WHO histologic subtype with certainty
- Core biopsies, especially multiple core biopsies, MAY be adequate, but needle aspirations or cytologies are not adequate
- Bone marrow core biopsy or clot sections (not aspirates) may be used as diagnostic material if it is significantly involved and are the only diagnostic material available
All patients must have bidimensional measurable disease documented on the Lymphoma Baseline Tumor Assessment Form (Form #48031)
- Patients who also have non-measurable disease in addition to measurable disease must have all nonmeasurable disease assessed within 28 days prior to registration
Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma
- Any laboratory or radiographic tests performed prior to registration to assess CNS involvement must be negative
Patients must have a unilateral/bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration
- If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes
Patients must be eligible for stem cell transplantation by institutional guidelines with the plan that transplant will be conducted at a cooperative group-approved transplant center
- Patients must be planning to undergo stem cell transplantation within 84 days after day 1 of the last induction course
- Patients must have had at least 1.5 X 10^6 CD34^+ cells/kg collected and stored prior to second registration for stem cell transplantation
PATIENT CHARACTERISTICS:
- Zubrod performance status of 0-2
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- Serum creatinine ≤ 2.0 times ULN
- ALT and AST ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Platelet count ≥ 100,000/mcL, unless due to bone marrow infiltration by lymphoma
All patients ≥ 45 years of age must have an echocardiogram (ECHO) or MUGA scan within 42 days prior to registration (whichever method is used at baseline must be used at restaging)
- Patients < 45 years of age should have ECHO/MUGA only if clinically indicated
- Patients with an ejection fraction < institutional lower limit of normal (ILLN) are not eligible
- Serum LDH and a CBC with differential must be measured within 28 days prior to registration
- Patients known to be HIV positive, or who have a history of solid organ transplantation, are ineligible
- No active hepatitis
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated Stage I or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for 5 years
- Pregnant or nursing women may not participate
- Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Hide Study Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| United States, Colorado | |
| Aurora Presbyterian Hospital | Recruiting |
| Aurora, Colorado, United States, 80012 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Boulder Community Hospital | Recruiting |
| Boulder, Colorado, United States, 80301-9019 | |
| Contact: Clinical Trials Office - Boulder Community Hospital 303-938-5253 | |
| Penrose Cancer Center at Penrose Hospital | Recruiting |
| Colorado Springs, Colorado, United States, 80933 | |
| Contact: Clinical Trials Office - Penrose Cancer Center 719-776-5275 | |
| Porter Adventist Hospital | Recruiting |
| Denver, Colorado, United States, 80210 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| CCOP - Colorado Cancer Research Program | Recruiting |
| Denver, Colorado, United States, 80222 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Rose Medical Center | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| St. Anthony Central Hospital | Recruiting |
| Denver, Colorado, United States, 80204 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| St. Joseph Hospital | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Presbyterian - St. Luke's Medical Center | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen 303-839-6000 | |
| Swedish Medical Center | Recruiting |
| Englewood, Colorado, United States, 80110 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| North Colorado Medical Center | Recruiting |
| Greeley, Colorado, United States, 80631 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Littleton Adventist Hospital | Recruiting |
| Littleton, Colorado, United States, 80122 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Sky Ridge Medical Center | Recruiting |
| Lone Tree, Colorado, United States, 80124 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Hope Cancer Care Center at Longmont United Hospital | Recruiting |
| Longmont, Colorado, United States, 80501 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| McKee Medical Center | Recruiting |
| Loveland, Colorado, United States, 80539 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Parker Adventist Hospital | Recruiting |
| Parker, Colorado, United States, 80138 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| St. Mary - Corwin Regional Medical Center | Recruiting |
| Pueblo, Colorado, United States, 81004 | |
| Contact: Eduardo R. Pajon, MD 303-399-8020ext2261 | |
| Exempla Lutheran Medical Center | Recruiting |
| Wheat Ridge, Colorado, United States, 80033 | |
| Contact: Clinical Trials Office - Exempla Lutheran Medical Center 303-403-3605 | |
| United States, Delaware | |
| Tunnell Cancer Center at Beebe Medical Center | Recruiting |
| Lewes, Delaware, United States, 19958 | |
| Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171 | |
| CCOP - Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-623-4450 | |
| United States, Florida | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| United States, Idaho | |
| St. Joseph Regional Medical Center | Recruiting |
| Lewiston, Idaho, United States, 83501 | |
| Contact: Yoshio Inoue 208-743-2511 | |
| United States, Illinois | |
| Illinois CancerCare - Bloomington | Recruiting |
| Bloomington%, Illinois, United States, 61701 | |
| Contact: Nguyet A. Le-Lindqwister 309-662-2102 | |
| Illinois CancerCare - Canton | Recruiting |
| Canton, Illinois, United States, 61520 | |
| Contact: Nguyet A. Le-Lindqwister 309-647-5240 | |
| Graham Hospital | Recruiting |
| Canton, Illinois, United States, 61520 | |
| Contact: Nguyet A. Le-Lindqwister 309-647-5240 | |
| Memorial Hospital | Recruiting |
| Carthage, Illinois, United States, 62321 | |
| Contact: Nguyet A. Le-Lindqwister 217-357-3131 | |
| Illinois CancerCare - Carthage | Recruiting |
| Carthage, Illinois, United States, 62321 | |
| Contact: Nguyet A. Le-Lindqwister 217-357-6877 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
| Hematology and Oncology Associates | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Clinical Trails Office - Hematology and Oncology Associates 312-695-1301 | |
| Decatur Memorial Hospital Cancer Care Institute | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-4750 | |
| Eureka Community Hospital | Recruiting |
| Eureka, Illinois, United States, 61530 | |
| Contact: Nguyet A. Le-Lindqwister 309-467-2371 | |
| Illinois CancerCare - Eureka | Recruiting |
| Eureka, Illinois, United States, 61530 | |
| Contact: Nguyet A. Le-Lindqwister 309-467-2371 | |
| Galesburg Clinic, PC | Recruiting |
| Galesburg, Illinois, United States, 61401 | |
| Contact: Nguyet A. Le-Lindqwister 309-344-1000 | |
| Illinois CancerCare - Galesburg | Recruiting |
| Galesburg, Illinois, United States, 61401 | |
| Contact: Nguyet A. Le-Lindqwister 309-344-9269 | |
| Mason District Hospital | Recruiting |
| Havana, Illinois, United States, 62644 | |
| Contact: Nguyet A. Le-Lindqwister 309-543-4431 | |
| Illinois CancerCare - Havana | Recruiting |
| Havana, Illinois, United States, 62644 | |
| Contact: Nguyet A. Le-Lindqwister 309-543-8557 | |
| Kellogg Cancer Care Center | Recruiting |
| Highland Park, Illinois, United States, 60035 | |
| Contact: Jane N. Winter, MD 312-695-4538 | |
| Provena St. Mary's Regional Cancer Center - Kankakee | Recruiting |
| Kankakee, Illinois, United States, 60901 | |
| Contact: Jane N. Winter, MD 312-695-4538 | |
| Illinois CancerCare - Kewanee Clinic | Recruiting |
| Kewanee, Illinois, United States, 61443 | |
| Contact: Nguyet A. Le-Lindqwister 309-852-0598 | |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Recruiting |
| Libertyville, Illinois, United States, 60048 | |
| Contact: Jane N. Winter, MD 312-695-4538 | |
| Illinois CancerCare - Macomb | Recruiting |
| Macomb, Illinois, United States, 61455 | |
| Contact: Nguyet A. Le-Lindqwister 309-833-3503 | |
| McDonough District Hospital | Recruiting |
| Macomb, Illinois, United States, 61455 | |
| Contact: Nguyet A. Le-Lindqwister 309-833-4101 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Illinois CancerCare - Monmouth | Recruiting |
| Monmouth, Illinois, United States, 61462 | |
| Contact: Nguyet A. Le-Lindqwister 309-734-3141 | |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | Recruiting |
| Niles, Illinois, United States, 60714 | |
| Contact: Jane N. Winter, MD 312-695-4538 | |
| BroMenn Regional Medical Center | Recruiting |
| Normal, Illinois, United States, 61761 | |
| Contact: Nguyet A. Le-Lindqwister 309-454-1400 | |
| Community Cancer Center | Recruiting |
| Normal, Illinois, United States, 61761 | |
| Contact: Nguyet A. Le-Lindqwister 309-451-8500 | |
| Illinois CancerCare - Community Cancer Center | Recruiting |
| Normal, Illinois, United States, 61761 | |
| Contact: Nguyet A. Le-Lindqwister 309-662-2102 | |
| Community Hospital of Ottawa | Recruiting |
| Ottawa, Illinois, United States, 61350 | |
| Contact: Nguyet A. Le-Lindqwister 815-433-3100 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Recruiting |
| Ottawa, Illinois, United States, 61350 | |
| Contact: Nguyet A. Le-Lindqwister 815-431-9270 | |
| Illinois CancerCare - Pekin | Recruiting |
| Pekin, Illinois, United States, 61603 | |
| Contact: Nguyet A. Le-Lindqwister 309-353-0214 | |
| Cancer Treatment Center at Pekin Hospital | Recruiting |
| Pekin, Illinois, United States, 61554 | |
| Contact: Nguyet A. Le-Lindqwister 309-353-0512 | |
| CCOP - Illinois Oncology Research Association | Recruiting |
| Peoria, Illinois, United States, 61615 | |
| Contact: Nguyet A. Le-Lindqwister 309-243-3605 | |
| Methodist Medical Center of Illinois | Recruiting |
| Peoria, Illinois, United States, 61636 | |
| Contact: Clinical Trials Office - Methodist Medical Center of Illinois 309-243-3000 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
| Peoria, Illinois, United States, 61615 | |
| Contact: Nguyet A. Le-Lindqwister 309-243-3000 | |
| Proctor Hospital | Recruiting |
| Peoria, Illinois, United States, 61614 | |
| Contact: Nguyet A. Le-Lindqwister 309-691-1000 | |
| Illinois Valley Community Hospital | Recruiting |
| Peru, Illinois, United States, 61354 | |
| Contact: Nguyet A. Le-Lindqwister 815-223-3000 | |
| Illinois CancerCare - Peru | Recruiting |
| Peru, Illinois, United States, 61354 | |
| Contact: Nguyet A. Le-Lindqwister 815-780-3185 | |
| Illinois CancerCare - Princeton | Recruiting |
| Princeton, Illinois, United States, 61356 | |
| Contact: Nguyet A. Le-Lindqwister 815-875-3010 | |
| Perry Memorial Hospital | Recruiting |
| Princeton, Illinois, United States, 61356 | |
| Contact: Nguyet A. Le-Lindqwister 815-875-2811 | |
| Hematology Oncology Associates - Skokie | Recruiting |
| Skokie, Illinois, United States, 60076 | |
| Contact: Jane N. Winter, MD 312-695-4538 | |
| Illinois CancerCare - Spring Valley | Recruiting |
| Spring Valley, Illinois, United States, 61362 | |
| Contact: Nguyet A. Le-Lindqwister 815-664-1487 | |
| Regional Cancer Center at Memorial Medical Center | Recruiting |
| Springfield, Illinois, United States, 62781-0001 | |
| Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me 217-788-4233 | |
| United States, Indiana | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Recruiting |
| Beech Grove, Indiana, United States, 46107 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Reid Hospital & Health Care Services | Recruiting |
| Richmond, Indiana, United States, 47374 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| United States, Iowa | |
| McFarland Clinic, PC | Recruiting |
| Ames, Iowa, United States, 50010 | |
| Contact: Clinical Trials Office - McFarland Clinic, PC 515-239-2621 | |
| Mercy Medical Center - Sioux City | Recruiting |
| Sioux City, Iowa, United States, 51102 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Siouxland Hematology-Oncology Associates, LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| St. Luke's Regional Medical Center | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Chanute | Recruiting |
| Chanute, Kansas, United States, 66720 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Dodge City | Recruiting |
| Dodge City, Kansas, United States, 67801 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - El Dorado | Recruiting |
| El Dorado, Kansas, United States, 67042 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas - Fort Scott | Recruiting |
| Fort Scott, Kansas, United States, 66701 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas-Independence | Recruiting |
| Independence, Kansas, United States, 67301 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Kingman | Recruiting |
| Kingman, Kansas, United States, 67068 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Lawrence Memorial Hospital | Recruiting |
| Lawrence, Kansas, United States, 66044 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Liberal | Recruiting |
| Liberal, Kansas, United States, 67901 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - McPherson | Recruiting |
| McPherson, Kansas, United States, 67460 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Newton | Recruiting |
| Newton, Kansas, United States, 67114 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Parsons | Recruiting |
| Parsons, Kansas, United States, 67357 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Pratt | Recruiting |
| Pratt, Kansas, United States, 67124 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Salina | Recruiting |
| Salina, Kansas, United States, 67401 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wellington | Recruiting |
| Wellington, Kansas, United States, 67152 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| CCOP - Wichita | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Associates in Womens Health, PA - North Review | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| Cancer Center of Kansas, PA - Winfield | Recruiting |
| Winfield, Kansas, United States, 67156 | |
| Contact: Shaker R. Dakhil, MD, FACP 316-262-4467 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| United States, Maryland | |
| Union Hospital of Cecil County | Recruiting |
| Elkton MD, Maryland, United States, 21921 | |
| Contact: Frank Beardell, MD 302-737-7700 | |
| United States, Michigan | |
| Hickman Cancer Center at Bixby Medical Center | Recruiting |
| Adrian, Michigan, United States, 49221 | |
| Contact: Clinical Trials Office - Hickman Cancer Center at Bixby Medica 517-265-0116 | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Mercy Memorial Hospital - Monroe | Recruiting |
| Monroe, Michigan, United States, 48162 | |
| Contact: Rex B. Mowat 734-240-8400 | |
| United States, Minnesota | |
| Fairview Ridges Hospital | Recruiting |
| Burnsville, Minnesota, United States, 55337 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Mercy and Unity Cancer Center at Mercy Hospital | Recruiting |
| Coon Rapids, Minnesota, United States, 55433 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Fairview Southdale Hospital | Recruiting |
| Edina, Minnesota, United States, 55435 | |
| Contact: Clinical Trials Office - Fairview Southdale Hospital 612-625-3650 | |
| Mercy and Unity Cancer Center at Unity Hospital | Recruiting |
| Fridley, Minnesota, United States, 55432 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Hutchinson Area Health Care | Recruiting |
| Hutchinson, Minnesota, United States, 55350 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| HealthEast Cancer Care at St. John's Hospital | Recruiting |
| Maplewood, Minnesota, United States, 55109 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Minnesota Oncology - Maplewood | Recruiting |
| Maplewood, Minnesota, United States, 55109 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Hennepin County Medical Center - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Clinical Trials Office - Hennepin County Medical Center - Minn 612-873-5911 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Recruiting |
| Minneapolis, Minnesota, United States, 55407 | |
| Contact: Clinical Trials Office - Virginia Piper Cancer Institute 612-863-5654 | |
| New Ulm Medical Center | Recruiting |
| New Ulm, Minnesota, United States, 56073 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Humphrey Cancer Center at North Memorial Outpatient Center | Recruiting |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor 763-520-1893 | |
| CCOP - Metro-Minnesota | Recruiting |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Park Nicollet Cancer Center | Recruiting |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| United Hospital | Recruiting |
| Saint Paul, Minnesota, United States, 55102 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| St. Francis Cancer Center at St. Francis Medical Center | Recruiting |
| Shakopee, Minnesota, United States, 55379 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Regions Hospital Cancer Care Center | Recruiting |
| St. Paul, Minnesota, United States, 55101 | |
| Contact: Clinical Trials Office - Regions Hospital Cancer Care Center 651-254-1517 | |
| Lakeview Hospital | Recruiting |
| Stillwater, Minnesota, United States, 55082 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Ridgeview Medical Center | Recruiting |
| Waconia, Minnesota, United States, 55387 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Willmar Cancer Center at Rice Memorial Hospital | Recruiting |
| Willmar, Minnesota, United States, 56201 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| Minnesota Oncology - Woodbury | Recruiting |
| Woodbury, Minnesota, United States, 55125 | |
| Contact: Patrick J. Flynn, MD 612-884-6300 | |
| United States, Missouri | |
| Saint Louis University Cancer Center | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Clinical Trials Office - Saint Louis University Cancer Center 314-977-4440 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Nancy L. Bartlett, MD 314-362-5654 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Hamilton | Recruiting |
| Hamilton, New Jersey, United States, 08690 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham 609-631-6946 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Cancer Institute of New Jersey at Cooper - Voorhees | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jonathan W. Friedberg 585-275-5345 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 Jamesline@osumc.edu | |
| Good Samaritan Hospital | Recruiting |
| Dayton, Ohio, United States, 45406 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| CCOP - Dayton | Recruiting |
| Dayton, Ohio, United States, 45420 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Grandview Hospital | Recruiting |
| Dayton, Ohio, United States, 45405 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Samaritan North Cancer Care Center | Recruiting |
| Dayton, Ohio, United States, 45415 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| David L. Rike Cancer Center at Miami Valley Hospital | Recruiting |
| Dayton, Ohio, United States, 45409 | |
| Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami 937-208-2079 | |
| Community Cancer Center | Recruiting |
| Elyria, Ohio, United States, 44035 | |
| Contact: Contact Person 440-324-0400 | |
| Hematology Oncology Center | Recruiting |
| Elyria, Ohio, United States, 44035 | |
| Contact: Rex B. Mowat 440-324-0401 | |
| Blanchard Valley Medical Associates | Recruiting |
| Findlay, Ohio, United States, 45840 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Middletown Regional Hospital | Recruiting |
| Franklin, Ohio, United States, 45005-1066 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Wayne Hospital | Recruiting |
| Greenville, Ohio, United States, 45331 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| Charles F. Kettering Memorial Hospital | Recruiting |
| Kettering, Ohio, United States, 45429 | |
| Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita 937-298-3399 ext. 57556 | |
| Lima Memorial Hospital | Recruiting |
| Lima, Ohio, United States, 45804 | |
| Contact: Rex B. Mowat 419-228-3335 | |
| Northwest Ohio Oncology Center | Recruiting |
| Maumee, Ohio, United States, 43537-1839 | |
| Contact: Rex B. Mowat 419-891-5600 | |
| St. Charles Mercy Hospital | Recruiting |
| Oregon, Ohio, United States, 43616 | |
| Contact: Rex B. Mowat 419-696-7200 | |
| North Coast Cancer Care, Incorporated | Recruiting |
| Sandusky, Ohio, United States, 44870 | |
| Contact: Rex B. Mowat 419-626-9090 | |
| Flower Hospital Cancer Center | Recruiting |
| Sylvania, Ohio, United States, 43560 | |
| Contact: Clinical Trials Office - Flower Hospital Cancer Center 419-824-1842 | |
| Mercy Hospital of Tiffin | Recruiting |
| Tiffin, Ohio, United States, 44883 | |
| Contact: Rex B. Mowat 419-447-3130 | |
| Medical University of Ohio Cancer Center | Recruiting |
| Toledo, Ohio, United States, 43614 | |
| Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen 419-383-6583 | |
| Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Clinical Trials Office - Toledo Hospital 419-824-1842 | |
| St. Anne Mercy Hospital | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact: Rex B. Mowat 419-407-2663 | |
| St. Vincent Mercy Medical Center | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Rex B. Mowat 419-251-4515 | |
| Toledo Clinic, Incorporated - Main Clinic | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact: Rex B. Mowat 419-479-5605 | |
| CCOP - Toledo Community Hospital | Recruiting |
| Toledo, Ohio, United States, 43617 | |
| Contact: Contact Person 419-843-6147 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | Recruiting |
| Troy, Ohio, United States, 45373-1300 | |
| Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall 937-440-4842 | |
| Fulton County Health Center | Recruiting |
| Wauseon, Ohio, United States, 43567 | |
| Contact: Clinical Trials Office - Fulton County Health Center 419-330-2708 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Recruiting |
| Xenia, Ohio, United States, 45385 | |
| Contact: Howard M. Gross, MD 937-832-1093 | |
| United States, Oregon | |
| Clackamas Radiation Oncology Center | Recruiting |
| Clackamas, Oregon, United States, 97015 | |
| Contact: Stacy K. Lewis 503-513-3300 | |
| Providence Milwaukie Hospital | Recruiting |
| Milwaukie, Oregon, United States, 97222 | |
| Contact: Stacy K. Lewis 503-513-8300 | |
| Providence Newberg Medical Center | Recruiting |
| Newberg, Oregon, United States, 97132 | |
| Contact: Stacy K. Lewis 503-537-1555 | |
| Willamette Falls Hospital | Recruiting |
| Oregon City, Oregon, United States, 97045 | |
| Contact: Stacy K. Lewis 503-650-6758 | |
| CCOP - Columbia River Oncology Program | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Stacy K. Lewis 503-216-6260 | |
| Providence St. Vincent Medical Center | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Clinical Trials Office - Providence St. Vincent Medical Center 503-215-6412 | |
| Providence Cancer Center at Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213-2967 | |
| Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 | |
| United States, Pennsylvania | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Geisinger Hazleton Cancer Center | Recruiting |
| Hazleton, Pennsylvania, United States, 18201 | |
| Contact: Edward J. Gorak, II 570-459-2901 | |
| Geisinger Medical Group - Scenery Park | Recruiting |
| State College, Pennsylvania, United States, 16801 | |
| Contact: Edward J. Gorak, II 814-231-4560 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Recruiting |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce 570-271-5251 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas - Faris Road | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Suzanne R. Fanning 864-679-3900 | |
| Greenville Hospital Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Clinical Trials Office - Greenville Hospital Cancer Center 864-241-6251 | |
| Cancer Centers of the Carolinas - Grove Commons | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Clinical Trials Office - Cancer Centers of the Carolinas 864-241-6251 | |
| CCOP - Greenville | Recruiting |
| Greenville, South Carolina, United States, 29615 | |
| Contact: Suzanne R. Fanning 864-241-6251 | |
| Cancer Centers of the Carolinas - Greer Medical Oncology | Recruiting |
| Greer, South Carolina, United States, 29650 | |
| Contact: Suzanne R. Fanning 864-662-4000 | |
| Cancer Centers of the Carolinas - Seneca | Recruiting |
| Seneca, South Carolina, United States, 29672 | |
| Contact: Suzanne R. Fanning 864-888-3717 | |
| Cancer Centers of the Carolinas - Spartanburg | Recruiting |
| Spartanburg, South Carolina, United States, 29307 | |
| Contact: Suzanne R. Fanning 864-699-5700 | |
| United States, Texas | |
| Baylor University Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Clinical Trials Office - Baylor University Medical Center - Da 800-422-9567 | |
| United States, Virginia | |
| Fredericksburg Oncology, Incorporated | Recruiting |
| Fredericksburg, Virginia, United States, 22401 | |
| Contact: Rex B. Mowat 540-368-0500 | |
| United States, Washington | |
| Island Hospital Cancer Care Center at Island Hospital | Recruiting |
| Anacortes, Washington, United States, 98221 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Overlake Cancer Center at Overlake Hospital Medical Center | Recruiting |
| Bellevue, Washington, United States, 98004 | |
| Contact: Yoshio Inoue 425-454-2148 | |
| St. Joseph Cancer Center | Recruiting |
| Bellingham, Washington, United States, 98225 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Olympic Hematology and Oncology | Recruiting |
| Bremerton, Washington, United States, 98310 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Highline Medical Center Cancer Center | Recruiting |
| Burien, Washington, United States, 98166 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Providence Centralia Hospital | Recruiting |
| Centralia, Washington, United States, 98531-9027 | |
| Contact: Clinical Trials Office - Providence Centralia H 360-493-4300 | |
| Providence Regional Cancer Partnership | Recruiting |
| Everett, Washington, United States, 98201 | |
| Contact: Yoshio Inoue 425-297-5500 | |
| St. Francis Hospital | Recruiting |
| Federal Way, Washington, United States, 98003 | |
| Contact: Yoshio Inoue 253-944-7997 | |
| Swedish Medical Center - Issaquah Campus | Recruiting |
| Issaquah, Washington, United States, 98029 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Columbia Basin Hematology | Recruiting |
| Kennewick, Washington, United States, 99336 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Skagit Valley Hospital Cancer Care Center | Recruiting |
| Mount Vernon, Washington, United States, 98274 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Providence St. Peter Hospital Regional Cancer Center | Recruiting |
| Olympia, Washington, United States, 98506-5166 | |
| Contact: Yoshio Inoue 360-493-7514 | |
| Harrison Poulsbo Hematology and Onocology | Recruiting |
| Poulsbo, Washington, United States, 98370 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Good Samaritan Cancer Center | Recruiting |
| Puyallup, Washington, United States, 98372 | |
| Contact: Yoshio Inoue 253-697-4000 | |
| Minor and James Medical, PLLC | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Group Health Central Hospital | Recruiting |
| Seattle, Washington, United States, 98112 | |
| Contact: Clinical Trials Office - Group Health Central Hospital 206-287-2900 | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Polyclinic First Hill | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Recruiting |
| Seattle, Washington, United States, 98122-4307 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Harborview Medical Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| North Puget Oncology at United General Hospital | Recruiting |
| Sedro-Woolley, Washington, United States, 98284 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Evergreen Hematology and Oncology, PS | Recruiting |
| Spokane, Washington, United States, 99218 | |
| Contact: Saul E. Rivkin, MD 206-386-2441 | |
| Cancer Care Northwest - Spokane South | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South 509-228-1083 | |
| CCOP - Northwest | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Yoshio Inoue 253-403-1461 | |
| St. Clare Hospital | Recruiting |
| Tacoma, Washington, United States, 98499 | |
| Contact: Yoshio Inoue 253-588-1711 | |
| Franciscan Cancer Center at St. Joseph Medical Center | Recruiting |
| Tacoma, Washington, United States, 98405-3004 | |
| Contact: Clinical Trials Office - Franciscan Cancer Center 253-426-6914 | |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Clinical Trials Office - MultiCare Regional Cancer Center 253-403-3229 | |
| Allenmore Hospital | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Yoshio Inoue 253-459-6446 | |
| Northwest Cancer Specialists at Vancouver Cancer Center | Recruiting |
| Vancouver, Washington, United States, 98684 | |
| Contact: Stacy K. Lewis 360-944-9889 | |
| Southwest Washington Medical Center Cancer Center | Recruiting |
| Vancouver, Washington, United States, 98664 | |
| Contact: Stacy K. Lewis 360-514-2174 | |
| Wenatchee Valley Medical Center | Recruiting |
| Wenatchee, Washington, United States, 98801-2028 | |
| Contact: Clinical Trials Office - Wenatchee Valley Medical Center 509-665-5800 | |
| United States, West Virginia | |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Contact: Mehdi Hamadani 304-293-4500 | |
| United States, Wisconsin | |
| Gundersen Lutheran Center for Cancer and Blood | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org | |
| Medical College of Wisconsin Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
| Principal Investigator: | Steven H. Bernstein, MD | James P. Wilmot Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01412879 History of Changes |
| Other Study ID Numbers: | CDR0000707601, SWOG-S1106 |
| Study First Received: | August 6, 2011 |
| Last Updated: | October 7, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Cytarabine Methotrexate Rituximab Nitrogen Mustard Compounds Bendamustine |
Dexamethasone Doxorubicin Vincristine Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Leucovorin Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 21, 2013