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Bone Marrow Transplantation for Chronic Lymphocytic Leukemia


Phase 2
16 Years
65 Years
Not Enrolling
Both
Leukemia

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Trial Information

Bone Marrow Transplantation for Chronic Lymphocytic Leukemia


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effectiveness of high dose cyclophosphamide, total body irradiation and bone marrow transplantation for chronic lymphocytic leukemia

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Richard E. Champlin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

DM90-106

NCT ID:

NCT00002844

Start Date:

March 1991

Completion Date:

June 2002

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • Cyclophosphamide
  • Cytoxan
  • Neosar
  • Bone Marrow Transplantation
  • total body irradiation
  • chronic lymphocytic leukemia
  • allogeneic
  • autologous
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009