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Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia

Phase 1/Phase 2
65 Years
Not Enrolling

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Trial Information

Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Advanced chronic lymphocytic leukemia (Rai stage 3 or 4) with at
least one of the following high-risk factors: Beta-2 microglobulin 3 or greater
Abnormalities of chromosome 17 Other cytogenetic abnormalities Refractory to
fludarabine-based chemotherapy or failure to achieve complete remission after 6 courses of
a fludarabine-based regimen HLA-identical sibling donor willing and able to undergo
apheresis for harvest of G-CSF-stimulated peripheral blood stem cells

PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Zubrod 0 or 1
Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less
than 1.5 mg/dL Cardiovascular: No symptomatic cardiac disease Pulmonary: No symptomatic
pulmonary disease Other: No active uncontrolled infection

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility + Toxicity of Combination Chemotherapy Plus Peripheral Stem Cell Transplantation

Outcome Time Frame:


Safety Issue:


Principal Investigator

Issa Khouri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1995

Completion Date:

July 2002

Related Keywords:

  • Leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009