Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia

Phase 2

Completed

• Conditions: Leukemia
• Interventions: Drug: Cyclophosphamide; Procedure: Allogeneic Bone Marrow Transplantation; Procedure: Autologous Bone Marrow Transplantation; Radiation: Total Body Irradiation (TBI)

• Registration Number: NCT00002844
• 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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with chronic lymphocytic leukemia.

Detailed Description

OBJECTIVES: Examine the potential role for high dose cyclophosphamide, total body irradiation and bone marrow transplantation for patients with chronic lymphocytic leukemia who are at high risk for disease progression.

OUTLINE: Patients receive daily intravenous infusions of cyclophosphamide for two days, followed by total body irradiation in four daily exposures. After completion of the total body irradiation, allogeneic or autologous bone marrow is infused intravenously.

PROJECTED ACCRUAL: 50 patients are expected to be accrued.

Study Timeline

• Study Start: 1991-03-05
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-06-05
• Study Completion: 2002-06-05
• Study First Submitted QC: 2004-06-22
• Study First Posted: 2004-06-23
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclophosphamide + TBI + BMT	Allogeneic Bone Marrow Transplantation	TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)
Cyclophosphamide + TBI + BMT	Autologous Bone Marrow Transplantation	TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)
Cyclophosphamide + TBI + BMT	Total Body Irradiation (TBI)	TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)
Cyclophosphamide + TBI + BMT	Cyclophosphamide	TBI = Total Body Irradiation and BMT = Bone Marrow Transplantation (allogeneic or autologous bone marrow)

Primary Outcome Measures

Name	Time	Method
Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia	1 year

Trial Locations

Locations (1)

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