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A Phase I-II Study of Pentostatin With Cyclophosphamide for Previously Treated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia


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

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Trial Information

A Phase I-II Study of Pentostatin With Cyclophosphamide for Previously Treated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia


OBJECTIVES:

- Determine the dose of cyclophosphamide, with filgrastim (G-CSF) support, that can be
safely administered with pentostatin and rituximab in patients with previously treated
intermediate- or high-risk chronic lymphocytic leukemia or other low-grade B-cell
malignancies. (Phase I closed to accrual effective 11/27/2001.)

- Characterize the toxicity of this regimen in these patients.

- Determine the incidence of response in these patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of cyclophosphamide (CTX).

- Phase I: Patients receive CTX IV followed by pentostatin IV on day 1 of course 1.
Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 3
and continuing until blood counts recover. During the second and subsequent courses,
patients receive CTX IV, pentostatin IV, and rituximab IV on day 1. Patients also
receive G-CSF as in course 1. Treatment repeats every 3 weeks for 3 courses in the
absence of disease progression or unacceptable toxicity. Patients with at least a
partial response after the third course receive an additional 3 courses.

Cohorts of 3-6 patients receive escalating doses of CTX until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity.

(Phase I closed to accrual effective 11/27/2001.)

- Phase II: Patients receive CTX at the recommended phase II dose and treatment as above.

Patients are followed at least every 3 months for 1 year and then periodically thereafter.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I portion of this
study. (Phase I closed to accrual effective 11/27/2001.) A total of 14-30 patients will be
accrued for the phase II portion of this study within 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Intermediate- or high-risk chronic lymphocytic leukemia (CLL) as defined by the
three-stage Rai system

- Rai intermediate disease must be active disease (including weight loss, fatigue,
fevers, evidence of progressive marrow failure, splenomegaly, progressive
lymphadenopathy, and progressive lymphocytosis with a rapid doubling time)

- Other low-grade B-cell neoplasms, including small lymphocytic lymphoma (and its
variants), Waldenstrom's macroglobulinemia, and follicular lymphoma allowed

- Autoimmune hemolytic anemia or autoimmune thrombocytopenia allowed regardless of
disease stage

- B-cells demonstrated by immunophenotypic (or immunohistochemical) analysis of the
malignant lymphocytes

- Must be previously treated

- For CLL, absolute lymphocytosis in the blood at least 5,000 lymphocytes/mm^3 OR

- Bone marrow lymphocytosis at least 30% of all nucleated cells

- No Rai intermediate-risk disease that meets the criteria of Montserrat "smoldering
leukemia" NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been
adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace
the former terminology of "low", "intermediate", or "high" grade lymphoma. However,
this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 4 weeks

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- No active infections requiring systemic antibiotics

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy

- Concurrent intravenous immunoglobulin allowed

- Concurrent epoetin alfa allowed

Chemotherapy:

- At least 4 weeks since prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Concurrent prednisone therapy allowed as long as dose is stable or decreasing over
the past 4 weeks

- No increase in prednisone therapy while on study

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mark Adam Weiss, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-083

NCT ID:

NCT00003658

Start Date:

September 1998

Completion Date:

October 2005

Related Keywords:

  • Leukemia
  • Lymphoma
  • Waldenström macroglobulinemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • 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

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021