Pentostatin, Cyclophosphamide, and Rituximab Followed By Lenalidomide in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00074282
First received: December 10, 2003
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and lenalidomide work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab, and lenalidomide work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Biological: filgrastim
Biological: pegfilgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: lenalidomide
Drug: pentostatin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Lenalidomide for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response (CR, nPR, PR) rate in all patients treated with PCR [ Designated as safety issue: No ]
  • Minimal-residual disease (MRD) as assessed by both flow cytometry and real-time allele-specific oligonucleotide polymerase chain reaction (RT-PCR) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as measured by CTCAE criteria every month [ Designated as safety issue: Yes ]
  • Overall survival and progression-free survival as measured by Kaplan-Meier method during study treatment [ Designated as safety issue: No ]
  • Rate of molecular complete remission (MCR) after the treatment of PCR and alemtuzumab (before May 2011) or lenalidomide after May 2011) in patients who achieve a CR or nPR [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: December 2004
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:

    • Peripheral blood absolute lymphocyte count greater than 5,000/mm^3
    • Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
    • Phenotypically characterized CLL defined by the following:

      • Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2)
      • B cell expresses either kappa or lambda light chains
      • Surface immunoglobulin with low cell surface density expression
  • Requires chemotherapy, as indicated by any of the following:

    • Disease-related symptoms

      • Weight loss of 10% or more within the past 6 months
      • Extreme fatigue
      • Fevers greater than 100.5°F for 2 weeks without evidence of infection
      • Night sweats without evidence of infection
    • Evidence of progressive marrow failure manifested by the development of or worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia (platelet count no greater than 100,000/mm^3)
    • Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
    • Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
    • Progressive lymphocytosis with an increase of greater than 50% over a 2-month period OR an anticipated doubling time of less than 6 months
  • Demonstrated progression after at least 1 course of either an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a meaningful response OR relapsed after prior therapy

    • Patients who have relapsed after a pentostatin-based regimen are eligible provided the response was greater than 12 months prior to study entry
  • No bone marrow dysplasia related to prior therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert syndrome)

Renal

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance ≥ 30 mL/min

Cardiovascular

  • No New York Heart Association class III or IV heart failure

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 methods of effective contraception (including 1 barrier method) for at least 28 days before starting lenalidomide, while participating in the study, and for at least 28 days after discontinuation/stopping lenalidomide
  • No other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Chemotherapy
  • At least 8 weeks since prior rituximab

Chemotherapy

  • See Disease Characteristics
  • At least 6 weeks since prior chemotherapy
  • At least 1 year since prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy

    • PCR therapy at least 1 year prior to study entry allowed
  • No prior lenalidomide

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent oral or IV antibiotics for active infection
  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: NCT00074282

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
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      
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      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
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      
CCOP - Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80222
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      
North Suburban Medical Center Recruiting
Thornton, Colorado, United States, 80229
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, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella, MD    734-712-1000      
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
Baptist Cancer Institute - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil    904-202-7051      
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Madhavi L. Venigalla, MD    508-368-3168      
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
United States, Illinois
Hematology and Oncology Associates Recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Trails Office - Hematology and Oncology Associates    312-695-1301      
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   
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Kellogg Cancer Care Center Recruiting
Highland Park, Illinois, United States, 60035
Contact: Shuo Ma    847-480-3800      
Hinsdale Hematology Oncology Associates Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Elyse C. Schneiderman, MD    630-654-1790      
Provena St. Mary's Regional Cancer Center - Kankakee Recruiting
Kankakee, Illinois, United States, 60901
Contact: Shuo Ma    815-937-8780      
North Shore Oncology and Hematology Associates, Limited - Libertyville Recruiting
Libertyville, Illinois, United States, 60048
Contact: Shuo Ma    847-367-6781      
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou, MD    563-359-9876      
Cancer Care and Hematology Specialists of Chicagoland - Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Shuo Ma    847-827-9060      
Swedish-American Regional Cancer Center Recruiting
Rockford, Illinois, United States, 61104-2315
Contact: Clinical Trials Office - Swedish-American Regional Cancer Cent    815-489-4413      
Hematology Oncology Associates - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Shuo Ma    847-568-9930      
United States, Indiana
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Bilal Ansari, MD    269-983-8260      
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Bilal Ansari, MD    269-983-8260      
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Bilal Ansari, MD    269-983-8260      
Saint Joseph Regional Medical Center Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Bilal Ansari, MD    269-983-8260      
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Bilal Ansari, MD    269-983-8260      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
United States, Iowa
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 - 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      
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      
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 - Wichita Recruiting
Wichita, Kansas, United States, 67214
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 - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Louisiana
Ochsner Health Center - Bluebonnet Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Charles V. Wendling, Jr.    225-761-5200      
Ochsner Health Center - Covington Recruiting
Covington, Louisiana, United States, 70433
Contact: Charles V. Wendling, Jr.    985-875-2828      
New Orleans Cancer Institute at Memorial Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Charles V. Wendling, Jr.    504-894-2700      
Ochsner Cancer Institute at Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Charles V. Wendling, Jr.    504-842-4360      
United States, Maryland
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Gregory A. Masters, MD    302-366-1200      
United States, Michigan
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD    734-712-1000      
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD    734-712-1000      
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp    313-593-8090      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center    810-762-8057      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute    810-762-8057      
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo    313-343-3166      
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD    734-712-1000      
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD    269-373-7458      
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD    269-373-7458      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center    517-364-2890      
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD    734-712-1000      
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD    734-712-1000      
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD    734-712-1000      
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw    989-776-8411      
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Bilal Ansari, MD    269-983-8260      
Lakeside Cancer Specialists, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Bilal Ansari, MD    269-983-8260      
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD    734-712-1000      
United States, Minnesota
MeritCare Bemidji Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston D. Steen, MD    701-234-2397      
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      
Minnesota Oncology - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
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      
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      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
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, New Jersey
Veterans Affairs Medical Center - East Orange Recruiting
East Orange, New Jersey, United States, 07018-1095
Contact: Basil S. Kasimis, MD, DSc    973-395-7809      
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
Beth Israel Medical Center - Petrie Division Recruiting
New York, New York, United States, 10003-3803
Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D    212-844-6286      
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
Roger Maris Cancer Center at MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
MetroHealth Cancer Care Center at MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Bruce J. Averbook, MD, FACS    216-778-4795      
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center    419-226-9617      
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      
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a    717-531-3779    CTO@hmc.psu.edu   
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: Witold B. Rybka, MD, FRCPC    717-531-1050      
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Recruiting
Reading, Pennsylvania, United States, 19612-6052
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center    610-988-9323      
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Edward J. Gorak, II    814-231-4560      
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16803
Contact: Witold B. Rybka, MD, FRCPC    717-531-1050      
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 Dakota
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center    605-328-1367      
United States, Wisconsin
Marshfield Clinic - Chippewa Center Recruiting
Chippewa Falls, Wisconsin, United States, 54729
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic Cancer Care at Regional Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Ali W. Bseiso, MD    715-387-5416      
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
Holy Family Memorial Medical Center Cancer Care Center Recruiting
Manitowoc, Wisconsin, United States, 54221-1450
Contact: Clinical Trials Office - Holy Family Memorial Medical Center C    920-320-2749      
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Gerald K. Bayer, MD    920-432-6049      
Saint Joseph's Hospital Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center    800-782-1581 ext. 94457      
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      
Marshfield Clinic - Lakeland Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Ali W. Bseiso, MD    715-387-5416      
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Indianhead Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Ali W. Bseiso, MD    715-387-5416      
St. Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Gerald K. Bayer, MD    920-432-6049      
Saint Michael's Hospital Cancer Center Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Wausau Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Ali W. Bseiso, MD    715-387-5416      
Diagnostic and Treatment Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Ali W. Bseiso, MD    715-387-5416      
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Sanford J. Kempin, MD Beth Israel Medical Center
Investigator: Neil E. Kay, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Kay NE, Kim HT, Kempin S, et al.: Predictors of clinical outcome to pentostatin, cyclophosphamide and rituximab (PCR) followed by campath for relapsed/refractory CLL : a study of the Eastern Cooperative Oncology Group, E2903. [Abstract] Blood 112 (11): A-1057, 2008.
Kempin S, Kay NE, Sun Z, et al.: Early results of pentostatin, cytoxan, rituximab (PCR) followed by CAMPATH-H (CA) for the treatment of relapse/refractory chronic lymphocytic leukemia (CLL) in ECOG protocol E2903. [Abstract] Blood 110 (11): A-3109, 2007.

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT00074282     History of Changes
Other Study ID Numbers: CDR0000343796, ECOG-2903
Study First Received: December 10, 2003
Last Updated: November 9, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Thalidomide
Rituximab
Lenalidomide
Pentostatin
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 23, 2014