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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002838

Enrollment

Registered

2004-06-16

Start date

1995-12-31

Completion date

2002-07-31

Last updated

2012-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia

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.

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.

Interventions

BIOLOGICALFilgrastim (G-CSF)

DRUGCyclophosphamide

DRUGFludarabine Phosphate

PROCEDUREPeripheral Blood Stem Cell Transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Feasibility + Toxicity of Combination Chemotherapy Plus Peripheral Stem Cell Transplantation	Monthly

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026