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

Phase 1

Completed

• Conditions: Leukemia
• Interventions: Biological: Filgrastim (G-CSF); Drug: Cyclophosphamide; Drug: Fludarabine Phosphate; Procedure: Peripheral Blood Stem Cell Transplantation

• Registration Number: NCT00002838
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 1995-12
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-07
• Study Completion: 2002-07
• Study First Submitted QC: 2004-06-15
• Study First Posted: 2004-06-16
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination Chemotherapy + PSCT	Peripheral Blood Stem Cell Transplantation	PSCT = Peripheral Stem Cell Transplantation
Combination Chemotherapy + PSCT	Filgrastim (G-CSF)	PSCT = Peripheral Stem Cell Transplantation
Combination Chemotherapy + PSCT	Cyclophosphamide	PSCT = Peripheral Stem Cell Transplantation
Combination Chemotherapy + PSCT	Fludarabine Phosphate	PSCT = Peripheral Stem Cell Transplantation

Primary Outcome Measures

Name	Time	Method
Feasibility + Toxicity of Combination Chemotherapy Plus Peripheral Stem Cell Transplantation	Monthly

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States