Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia

Leukemia Clinical Trial

Official title:

Bone Marrow Transplantation for Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002844
• Other study ID #: DM90-106
• Secondary ID: P30CA016672MDA-D
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 1991
• Est. completion date: June 5, 2002

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 5, 2002
• Est. primary completion date: June 5, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

DISEASE CHARACTERISTICS: Chronic lymphocytic leukemia (CLL) patients after initial relapse who have achieved a complete or partial remission with fludarabine therapy or after initial relapse or progression Prolymphocytic leukemia in first remission or after relapse Patients 15-65 years old who lack an HLA-identical sibling are eligible for autologous BM transplantation Patients 16-50 years old with an HLA identical or one antigen mismatched related donor are eligible for allogeneic BM transplantation

PATIENT CHARACTERISTICS: Age: 15-65 (See Disease Characteristics) Performance status:

Zubrod no more than 2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% of predicted Other: No severe concomitant medical or psychiatric illnesses

PRIOR CONCURRENT THERAPY: No extensive prior radiotherapy which would prevent administration of total body radiation Patients may also participate in study MDA-DM-92082 for retroviral gene marking of the autologous marrow and blood cells

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Cyclophosphamide
Daily intravenous infusions of cyclophosphamide for two days,

Procedure:
• Allogeneic Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.
• Autologous Bone Marrow Transplantation
After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

Radiation:
• Total Body Irradiation (TBI)
Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia		1 year

External Links

•   UT MD Anderson Cancer Center Website