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Clinical Trials (PDQ®)

  • First Published: 11/20/2003
  • Last Modified: 1/31/2012

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

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCIECOG-2903
NCT00074282, E2903

Objectives

Primary

  1. Determine the objective response rate (complete remission, partial remission [PR], or nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by lenalidomide.
  2. Determine the presence of minimal residual disease in patients treated with this regimen.

Secondary

  1. Determine the toxicity of this regimen in these patients.
  2. Evaluate the toxicity of the combined therapy, PCR with lenalidomide, in patients with previously treated B-CLL.
  3. Determine the overall and progression-free survival of patients treated with this regimen.
  4. Evaluate the number of patients who after PCR (or during PCR for PD), only achieve a PR, SD, or PD and who subsequently convert to a higher response category after lenalidomide.
  5. Correlate VH gene mutation status and CD38 expression of the CLL B-cell clones with clinical outcome in patients treated with this regimen.
  6. Correlate the differential expression of genes in the leukemic cells with clinical outcome in patients treated with this regimen.
  7. Correlate surface phenotype and genetic defects of the CLL B-cell clones with clinical outcome and gene expression patterns in patients treated with this regimen.

Exploratory

  1. Assess the angiogenic profile (i.e., secretion levels of pro- versus anti-angiogenic molecules) of CLL B cell clones as well as bone marrow angiogenesis (i.e., vascular density by immunohistochemistry) at baseline, after PCR, after lenalidomide, every six months (serum only), and at time of response assessment (marrow).
  2. Determine the VH gene mutation status and CD38 expression of the B-CLL clones at study entry and at the end of the therapy and assess the association between the VH gene mutation status and CD38 expression and clinical outcome.
  3. Determine surface phenotype (by flow cytometry) and genetic defects (by CLL FISH panel) information on CLL-B cell clones and associate with clinical outcome.
  4. Monitor the T-cell status by repertoire and flow cytometry analysis to determine the nature and extent of T-cell deficiency induced by the PCR and lenalidomide treatment and assess any association with clinical outcome and toxicities.

Entry Criteria

Disease Characteristics:

  • Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:
    • Peripheral blood absolute lymphocyte count greater than 5,000/mm3
    • 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/mm3)
    • 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

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

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

Expected Enrollment

110

A total of 26-110 patients will be accrued for this study within 1.5 years.

Outcomes

Primary Outcome(s)

Response (CR, nPR, PR) rate in all patients treated with PCR
Minimal-residual disease (MRD) as assessed by both flow cytometry and real-time allele-specific oligonucleotide polymerase chain reaction (RT-PCR)

Secondary Outcome(s)

Toxicity as measured by CTCAE criteria every month
Overall survival and progression-free survival as measured by Kaplan-Meier method during study treatment
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

Outline

This is a multicenter study.

Pentostatin, cyclophosphamide, and rituximab (PCR)* therapy: Patients receive pentostatin IV over 10-30 minutes, cyclophosphamide IV over 30-60 minutes, and rituximab** IV on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 or pegfilgrastim SC on day 1 and continuing until blood counts recover. Treatment repeats every 28 days for a total of 6 courses in the absence of unacceptable toxicity.

 [Note: *Patients demonstrating progression while receiving PCR must have completed 2 courses of PCR prior to proceeding to lenalidomide therapy.]

 [Note: **Patients receive rituximab IV on days 1, 3, and 5 for course 1 only; for courses 2-6, patients receive rituximab on day 1 only.]

Lenalidomide*** therapy: Eight weeks after completion of PCR therapy or when diagnosed with progressive disease, patients receive lenalidomide orally (PO) on days 1-28. In the absence of disease progression or unacceptable toxicity, treatment repeats every 28 days for patients with partial remission (PR), stable disease, or progressive disease after PCR. Patients who achieve complete remission proceed to clinical observation.

 [Note: ***The alemtuzumab therapy was replaced by lenalidomide therapy in May, 2011.]

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Published Results

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Sanford Kempin, MD, Protocol chair
Ph: 212-604-6010
Neil Kay, MD, Protocol co-chair
Ph: 507-266-0523
Email: kay.neil@mayo.edu

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Colorado
  Aurora
 Aurora Presbyterian Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Boulder
 Boulder Community Hospital
 Clinical Trials Office - Boulder Community Hospital
Ph: 303-938-5253
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Clinical Trials Office - Penrose Cancer Center
Ph: 719-776-5275
  Denver
 CCOP - Colorado Cancer Research Program
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Porter Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 Presbyterian - St. Luke's Medical Center
 Clinical Trials Office - Presbyterian - St. Luke's Medical Center
Ph: 303-839-6000
 Rose Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Anthony Central Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
 St. Joseph Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Englewood
 Swedish Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Grand Junction
 St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Greeley
 North Colorado Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Littleton
 Littleton Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Lone Tree
 Sky Ridge Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Loveland
 McKee Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Parker
 Parker Adventist Hospital
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Thornton
 North Suburban Medical Center
 Eduardo Pajon, MD
Ph: 303-399-8020ext2261
  Wheat Ridge
 Exempla Lutheran Medical Center
 Clinical Trials Office - Exempla Lutheran Medical Center
Ph: 303-403-3605
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip Stella, MD
Ph: 734-712-1000
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Clinical Trials Office - Tunnell Cancer Center
Ph: 302-645-3171
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-623-4450
Florida
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Clinical Trials Office - Baptist Cancer Institute - Jacksonville
Ph: 904-202-7051
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Madhavi Venigalla, MD
Ph: 508-368-3168
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Clinical Trials Office - Saint Alphonsus Cancer Care Center
Ph: 208-367-7954
Illinois
  Chicago
 Hematology and Oncology Associates
 Clinical Trails Office - Hematology and Oncology Associates
Ph: 312-695-1301
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Ph: 312-695-1301
  Email: cancer@northwestern.edu
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-4750
  Highland Park
 Kellogg Cancer Care Center
 Shuo Ma
Ph: 847-480-3800
  Hinsdale
 Hinsdale Hematology Oncology Associates
 Elyse Schneiderman, MD
Ph: 630-654-1790
  Kankakee
 Provena St. Mary's Regional Cancer Center - Kankakee
 Shuo Ma
Ph: 815-937-8780
  Libertyville
 North Shore Oncology and Hematology Associates, Limited - Libertyville
 Shuo Ma
Ph: 847-367-6781
  Moline
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 Costas Constantinou, MD
Ph: 563-359-9876
  Niles
 Cancer Care and Hematology Specialists of Chicagoland - Niles
 Shuo Ma
Ph: 847-827-9060
  Rockford
 Swedish-American Regional Cancer Center
 Clinical Trials Office - Swedish-American Regional Cancer Center
Ph: 815-489-4413
  Skokie
 Hematology Oncology Associates - Skokie
 Shuo Ma
Ph: 847-568-9930
Indiana
  Elkhart
 Elkhart General Hospital
 Bilal Ansari, MD
Ph: 269-983-8260
  Kokomo
 Howard Community Hospital
 Bilal Ansari, MD
Ph: 269-983-8260
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Bilal Ansari, MD
Ph: 269-983-8260
  Mishawaka
 Saint Joseph Regional Medical Center
 Bilal Ansari, MD
Ph: 269-983-8260
  South Bend
 CCOP - Northern Indiana CR Consortium
 Bilal Ansari, MD
Ph: 269-983-8260
 Memorial Hospital of South Bend
 Clinical Trials Office - Memorial Hospital of South Bend
Ph: 800-284-7370
Iowa
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Wender, MD, PhD
Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Wender, MD, PhD
Ph: 712-252-0088
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Charles Wendling, Jr.
Ph: 225-761-5200
  Covington
 Ochsner Health Center - Covington
 Charles Wendling, Jr.
Ph: 985-875-2828
866-624-7637
  New Orleans
 New Orleans Cancer Institute at Memorial Medical Center
 Charles Wendling, Jr.
Ph: 504-894-2700
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Charles Wendling, Jr.
Ph: 504-842-4360
888-624-7637
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Clinical Trials Office - Greater Baltimore Medical Center Cancer Center
Ph: 443-849-3706
  Elkton MD
 Union Hospital of Cecil County
 Gregory Masters, MD
Ph: 302-366-1200
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip Stella, MD
Ph: 734-712-1000
 Saint Joseph Mercy Cancer Center
 Philip Stella, MD
Ph: 734-712-1000
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Jackson
 Foote Memorial Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7458
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
  Lansing
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Pontiac
 St. Joseph Mercy Oakland
 Philip Stella, MD
Ph: 734-712-1000
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Bilal Ansari, MD
Ph: 269-983-8260
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Bilal Ansari, MD
Ph: 269-983-8260
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston Steen, MD
Ph: 701-234-2397
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Hutchinson
 Hutchinson Area Health Care
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Stillwater
 Lakeview Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
New Jersey
  East Orange
 Veterans Affairs Medical Center - East Orange
 Basil Kasimis, MD, DSc
Ph: 973-395-7809
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
New York
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine
Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  New York
 Beth Israel Medical Center - Petrie Division
 Clinical Trials Office - Beth Israel Medical Center - Petrie Division
Ph: 212-844-6286
North Dakota
  Fargo
 CCOP - MeritCare Hospital
 Preston Steen, MD
Ph: 701-234-2397
 Roger Maris Cancer Center at MeritCare Hospital
 Preston Steen, MD
Ph: 701-234-2397
Ohio
  Cleveland
 Case Comprehensive Cancer Center
 Clinical Trials Office - Case Comprehensive Cancer Center
Ph: 800-641-2422
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce Averbook, MD, FACS
Ph: 216-778-4795
  Lima
 St. Rita's Medical Center
 Clinical Trials Office - St. Rita's Medical Center
Ph: 419-226-9617
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  Hazleton
 Geisinger Hazleton Cancer Center
 Edward Gorak, II
Ph: 570-459-2901
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Clinical Trials Office - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Lewistown
 Lewistown Hospital
 Witold Rybka, MD, FRCPC
Ph: 717-531-1050
  Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Clinical Trials Office - McGlinn Family Regional Cancer Center
Ph: 610-988-9323
  State College
 Geisinger Medical Group - Scenery Park
 Edward Gorak, II
Ph: 814-231-4560
 Mount Nittany Medical Center
 Witold Rybka, MD, FRCPC
Ph: 717-531-1050
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Ph: 570-271-5251
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Hamied Rezazadeh, MD
Ph: 715-847-2121
  Chippewa Falls
 Marshfield Clinic - Chippewa Center
 Ali Bseiso, MD
Ph: 715-387-5416
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Ali Bseiso, MD
Ph: 715-387-5416
  Marshfield
 Marshfield Clinic - Marshfield Center
 Clinical Trials Office - Marshfield Clinic - Marshfield Center
Ph: 800-782-1581 ext. 94457
  Milwaukee
 Medical College of Wisconsin Cancer Center
 Clinical Trials Office - Medical College of Wisconsin Cancer Center
Ph: 414-805-4380
  Minocqua
 Marshfield Clinic - Lakeland Center
 Ali Bseiso, MD
Ph: 715-387-5416
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Ali Bseiso, MD
Ph: 715-387-5416
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Ali Bseiso, MD
Ph: 715-387-5416
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Ali Bseiso, MD
Ph: 715-387-5416
  Wausau
 Marshfield Clinic - Wausau Center
 Ali Bseiso, MD
Ph: 715-387-5416
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Clinical Trials Office - University of Wisconsin Cancer Center
Ph: 608-262-5223
  Weston
 Marshfield Clinic - Weston Center
 Ali Bseiso, MD
Ph: 715-387-5416
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Ali Bseiso, MD
Ph: 715-387-5416

Registry Information
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
Trial Start Date 2004-12-16
Trial Completion Date 2009-06-23 (estimated)
Registered in ClinicalTrials.gov NCT00074282
Date Submitted to PDQ 2003-11-04
Information Last Verified 2012-01-31
NCI Grant/Contract Number CA21115

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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