S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

This study has been terminated.
(toxicity in one arm)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01412879
First received: August 6, 2011
Last updated: July 23, 2014
Last verified: June 2014
  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
Intervention Model: Parallel Assignment
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • PFS at 2 years [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.


Secondary Outcome Measures:
  • Toxicity of R-HCVAD/MTX/Ara-C and autologous stem cell transplant (ASCT) or R-bendamustine and ASCT [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

  • Response rate (complete and partial response) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.

  • Overall survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.


Enrollment: 53
Study Start Date: November 2011
Estimated Primary Completion Date: June 2015 (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
Criteria

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
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (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 Multi Gated Acquisition Scan (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 Lactate dehydrogenase (LDH) and a Complete Blood Count (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412879

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Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80222
Rose Medical Center
Denver, Colorado, United States, 80220
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
St. Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
United States, Idaho
St. Joseph Regional Medical Center
Lewiston, Idaho, United States, 83501
United States, Illinois
Illinois CancerCare - Bloomington
Bloomington%, Illinois, United States, 61701
Illinois CancerCare - Canton
Canton, Illinois, United States, 61520
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Illinois CancerCare - Carthage
Carthage, Illinois, United States, 62321
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare - Eureka
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Illinois CancerCare - Havana
Havana, Illinois, United States, 62644
Kellogg Cancer Care Center
Highland Park, Illinois, United States, 60035
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, United States, 60901
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States, 61443
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Illinois CancerCare - Macomb
Macomb, Illinois, United States, 61455
McDonough District Hospital
Macomb, Illinois, United States, 61455
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States, 61462
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States, 60714
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Illinois CancerCare - Pekin
Pekin, Illinois, United States, 61603
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare - Peru
Peru, Illinois, United States, 61354
Illinois CancerCare - Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States, 61362
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
CCOP - Dayton
Dayton, Ohio, United States, 45420
Grandview Hospital
Dayton, Ohio, United States, 45405
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Community Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Toledo Hospital
Toledo, Ohio, United States, 43606
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Willamette Falls Hospital
Oregon City, Oregon, United States, 97045
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States, 29605
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, United States, 29650
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Texas
Baylor University Medical Center - Dallas
Dallas, Texas, United States, 75246
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, Washington
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Overlake Cancer Center at Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center Cancer Center
Burien, Washington, United States, 98166
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
St. Francis Hospital
Federal Way, Washington, United States, 98003
Swedish Medical Center - Issaquah Campus
Issaquah, Washington, United States, 98029
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States, 98274
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, United States, 98370
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
Polyclinic First Hill
Seattle, Washington, United States, 98122
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Harborview Medical Center
Seattle, Washington, United States, 98104
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States, 98284
Evergreen Hematology and Oncology, PS
Spokane, Washington, United States, 99218
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
CCOP - Northwest
Tacoma, Washington, United States, 98405
St. Clare Hospital
Tacoma, Washington, United States, 98499
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
Allenmore Hospital
Tacoma, Washington, United States, 98405
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, United States, 98684
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98664
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Steven H. Bernstein, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01412879     History of Changes
Other Study ID Numbers: CDR0000707601, S1106, U10CA032102
Study First Received: August 6, 2011
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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
Bendamustine
Nitrogen Mustard Compounds
Liposomal doxorubicin
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

ClinicalTrials.gov processed this record on August 28, 2014