Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00002838

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: Filgrastim (G-CSF) Drug: Cyclophosphamide Drug: Fludarabine Phosphate Procedure: Peripheral Blood Stem Cell Transplantation	Phase 1/Phase 2

Detailed Description

OBJECTIVES: I. Determine the feasibility and toxicity of using allogeneic peripheral blood stem cell transplantation after intensive, but non-myeloablative chemotherapy with fludarabine/cyclophosphamide in patients with advanced chronic lymphocytic leukemia. II. Determine the engraftment kinetics and degree of chimerism available with this strategy.

OUTLINE: This is a nonrandomized, dose-seeking study. Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest. Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days, with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined. Three days after intensive chemotherapy, allogeneic stem cells are infused. Responding patients who do not experience worse than grade 1 acute graft-vs.-host disease receive additional stem cell infusions after 60 and 120 days. Patients are followed monthly for 4 months, at 6 and 12 months, then yearly for 5 years.

PROJECTED ACCRUAL: Up to 25 patients will be entered.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia

Study Start Date :

Dec 1, 1995

Actual Primary Completion Date :

Jul 1, 2002

Actual Study Completion Date :

Jul 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination Chemotherapy + PSCT PSCT = Peripheral Stem Cell Transplantation	Biological: Filgrastim (G-CSF) Other Names: G-CSF Neupogen Drug: Cyclophosphamide Other Names: Cytoxan Neosar Drug: Fludarabine Phosphate Other Names: Fludara Procedure: Peripheral Blood Stem Cell Transplantation Other Names: PBSCT Stem Cell Transplant

Arm

Intervention/Treatment

Experimental: Combination Chemotherapy + PSCT

PSCT = Peripheral Stem Cell Transplantation

Biological: Filgrastim (G-CSF)

Other Names:

G-CSF

Neupogen

Drug: Cyclophosphamide

Other Names:

Cytoxan

Neosar

Drug: Fludarabine Phosphate

Other Names:

Fludara

Procedure: Peripheral Blood Stem Cell Transplantation

Other Names:

PBSCT

Stem Cell Transplant

Outcome Measures

Primary Outcome Measures

Feasibility + Toxicity of Combination Chemotherapy Plus Peripheral Stem Cell Transplantation [Monthly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Advanced chronic lymphocytic leukemia (Rai stage 3 or 4) with at least one of the following high-risk factors: Beta-2 microglobulin 3 or greater Abnormalities of chromosome 17 Other cytogenetic abnormalities Refractory to fludarabine-based chemotherapy or failure to achieve complete remission after 6 courses of a fludarabine-based regimen HLA-identical sibling donor willing and able to undergo apheresis for harvest of G-CSF-stimulated peripheral blood stem cells

PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1 Hematopoietic:

Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic pulmonary disease Other: No active uncontrolled infection

PRIOR CONCURRENT THERAPY: See Disease Characteristics