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Pentostatin, Cyclophosphamide And Rituximab (PCR) For B-Cell Chronic Lymphocytic Leukemia (CLL) And Small B-Cell Lymphocytic Lymphoma (SLL): Four Phase II Trials With Patient Stratification Based On Prior Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

Pentostatin, Cyclophosphamide And Rituximab (PCR) For B-Cell Chronic Lymphocytic Leukemia (CLL) And Small B-Cell Lymphocytic Lymphoma (SLL): Four Phase II Trials With Patient Stratification Based On Prior Therapy


OBJECTIVES:

- Determine the efficacy of pentostatin, cyclophosphamide, and rituximab, in terms of
response rate, time to treatment failure, time to disease progression, durability of
response, and overall survival, in patients with B-cell chronic lymphocytic leukemia or
small B-cell lymphocytic lymphoma.

- Determine the safety of this regimen, in terms of acute, subacute, and chronic
toxicity, in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (no prior chemotherapy for chronic lymphocytic leukemia vs prior purine
analog-based therapy [fludarabine or cladribine] but no alkylator therapy vs prior
alkylator-based therapy [chlorambucil or cyclophosphamide] but no prior purine analog
therapy vs prior therapy with alkylators and purine analogs, but not as combination
therapy).

- First course: Patients receive rituximab IV over 1-4 hours on days 1-3 and pentostatin
IV over 10-30 minutes and cyclophosphamide IV over 30-60 minutes on day 1.

- All subsequent courses: Patients receive rituximab IV over 60 minutes, pentostatin IV
over 10-30 minutes, and cyclophosphamide IV over 30-60 minutes on day 1. Treatment
repeats every 3 weeks for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 160-240 patients (40-60 per stratum) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small B-cell lymphocytic
lymphoma (SLL) with the following:

- Lymph node biopsy interpreted as SLL or consistent with CLL or all of the
following:

- Peripheral lymphocyte count greater than 5,000/mm^3 with small to moderate
peripheral lymphocytes and no more than 55% prolymphocytes

- Bone marrow aspirate containing at least 30% lymphoid cells

- Immunophenotypic evaluation of peripheral blood lymphocytes demonstrating
monoclonality of B lymphocytes with all of the following:

- CD19 or CD20 coexpressed with CD5 antigen in the absence of other
pan-T- cell markers (e.g., CD2 or CD3)

- Expression of CD23 on CLL cells or Dim B-cell expression of kappa or
lambda light chains

- Measurable disease with any of the following:

- 1 or more lymph nodes at least 1.5 cm by CT scan

- Splenomegaly by CT scan

- Peripheral lymphocyte count greater than 5,000/mm3 with coexpression of CD5 and
B-cell markers

- Bone marrow aspirate with at least 30% lymphoid cells

- No mantle cell lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 2 years

Hematopoietic

- See Disease Characteristics

- No immune thrombocytopenia

- No hemolytic anemia

Hepatic

- Bilirubin no greater than 3 times upper limit of normal (ULN)

- SGOT no greater than 3 times ULN (unless due to hemolysis or CLL)

- No hepatitis

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- No cardiac dysfunction

- No New York Heart Association class III or IV heart disease

- No myocardial infarction within the past month

Other

- HIV negative

- No active acute or chronic infection

- No immunosuppressive diseases

- No autoimmune disorder

- No secondary malignancy that is projected to limit life expectancy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Chemotherapy

- No prior rituximab

- At least 4 weeks since prior biologic therapy

Chemotherapy

- At least 4 weeks since prior chemotherapy

- No prior combination chemotherapy and rituximab or other antibody therapy

- No prior combination chemotherapy comprising an alkylating agent and a purine
nucleoside analog (i.e., cyclophosphamide or chlorambucil in combination with
fludarabine, cladribine, or pentostatin)

- No prior pentostatin

Endocrine therapy

- At least 4 weeks since prior corticosteroids

- No concurrent supra-physiologic doses of corticosteroids

Radiotherapy

- At least 4 weeks since prior radiotherapy

Surgery

- At least 4 weeks since prior major surgery

Other

- No concurrent immunosuppressive therapy (e.g., cyclosporine)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Hoag Memorial Hospital Presbyterian

Authority:

United States: Federal Government

Study ID:

CDR0000258096

NCT ID:

NCT00049413

Start Date:

June 2002

Completion Date:

December 2005

Related Keywords:

  • Leukemia
  • Lymphoma
  • B-cell chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Hoag Cancer Center at Hoag Memorial Hospital PresbyterianNewport Beach, California  92663