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

  Show 145 Study Locations
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 20, 2014