Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic Leukemia

Bone Marrow Transplantation for Chronic Lymphocytic Leukemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002844

Enrollment

Registered

2004-06-23

Start date

1991-03-05

Completion date

2002-06-05

Last updated

2018-10-25

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

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemia, Cyclophosphamide, Cytoxan, Neosar, Bone Marrow Transplantation, total body irradiation, chronic lymphocytic leukemia, allogeneic, autologous

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.

Interventions

DRUGCyclophosphamide

Daily intravenous infusions of cyclophosphamide for two days,

PROCEDUREAllogeneic Bone Marrow Transplantation

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

PROCEDUREAutologous Bone Marrow Transplantation

After completion of the TBI, allogeneic or autologous bone marrow infused intravenously.

RADIATIONTotal Body Irradiation (TBI)

Following 2 days of cyclophosphamide, TBI in four daily exposures then bone marrow transplant.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

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