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A PHASE III RANDOMIZED STUDY COMPARING G-CSF MOBILIZED PERIPHERAL BLOOD STEM CELLS WITH MARROW AS THE SOURCE OF STEM CELLS FOR ALLOGENEIC TRANSPLANTS FROM HLA IDENTICAL, RELATED DONORS FOR THE TREATMENT OF CHRONIC MYELOID LEUKEMIA


Phase 3
15 Years
65 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A PHASE III RANDOMIZED STUDY COMPARING G-CSF MOBILIZED PERIPHERAL BLOOD STEM CELLS WITH MARROW AS THE SOURCE OF STEM CELLS FOR ALLOGENEIC TRANSPLANTS FROM HLA IDENTICAL, RELATED DONORS FOR THE TREATMENT OF CHRONIC MYELOID LEUKEMIA


OBJECTIVES: I. Compare the incidence of persistent cytogenetic or hematologic relapse in
patients with chronic myeloid leukemia in chronic or accelerated phase treated with
transplantation using filgrastim (G-CSF)-mobilized peripheral blood stem cells vs bone
marrow from HLA-identical, related donors. II. Compare survival and nonrelapse mortality in
patients treated with these regimens. III. Compare incidence and severity of acute and
chronic graft versus host disease in patients treated with these regimens. IV. Compare
hospitalization and treatment associated expenses for patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(15-39 vs 40-65), interval from diagnosis to transplantation (under 2 years vs 2 years or
more, and permutations of patient and donor gender. Patients are randomized to one of two
treatment arms. Arm I: Patients receive a preparative regimen comprising busulfan orally or
IV 4 times daily on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic
filgrastim (G-CSF)-mobilized peripheral blood stem cells are infused on day 0. Arm II:
Busulfan and cyclophosphamide are administered as in arm I. Allogeneic bone marrow is
infused on day 0. Patients receive graft-versus-host disease prophylaxis comprising
methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours or orally every
12 hours on days -1 to 80 and then tapered. Patients are followed every 6 months for 2 years
and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of chronic myeloid leukemia (CML) in chronic phase No
chromosomal abnormalities other than a single Philadelphia chromosome (Ph) and less than
10% blasts in bone marrow and peripheral blood OR Diagnosis of CML in accelerated phase
Must meet 1 of the following criteria: More than 10% and less than 30% myeloblasts plus
promyelocytes in bone marrow or peripheral blood Major perturbations of WBC, platelet
count, or hematocrit uncontrolled by chemotherapy with busulfan or hydroxyurea Progressive
splenomegaly Extramedullary tumor Presence of any nonconstitutional cytogenetic
abnormality in addition to a single Ph chromosome Persistent unexplained fever or bone
pain Ph positive OR bcr/abl positive by reverse-transcriptase polymerase chain reaction or
Southern blot No CML in blast phase

PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Not specified Life expectancy:
At least 6 months based on any concurrent nonmalignant disease Hematopoietic: Not
specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless
due to CML) SGOT and SGPT no greater than 2 times ULN (unless due to CML) Renal:
Creatinine no greater than 1.4 mg/dL Cardiovascular: Cardiac ejection fraction at least
45% Pulmonary: DLCO at least 50% predicted Other: HIV negative Donor Entry Criteria:
HLA-identical family member No psychological, physiological, or medical condition that
would preclude harvest of peripheral blood stem cells or bone marrow HIV negative
Hepatitis A, B, and C antigen negative Negative pregnancy test Age 12 years and over

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jerry Radich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1092.00

NCT ID:

NCT00002789

Start Date:

May 1996

Completion Date:

September 2001

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109