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Fludarabine And Busulfan As Conditioning For Patients With Chronic Myeloid Leukemia Or Myelodysplastic Syndrome Transplanted With Hematopoietic Stem Cells From HLA-Compatible Related Or Unrelated Donors


Phase 2
N/A
65 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

Fludarabine And Busulfan As Conditioning For Patients With Chronic Myeloid Leukemia Or Myelodysplastic Syndrome Transplanted With Hematopoietic Stem Cells From HLA-Compatible Related Or Unrelated Donors


OBJECTIVES: I. Determine the incidence of nonrelapse mortality at 100 days after allogeneic
peripheral blood stem cell transplantation in patients with chronic myelogenous leukemia
(CML) or myelodysplastic syndrome (MDS) treated with fludarabine and busulfan. II. Determine
the incidence of donor stem cell engraftment in patients treated with this regimen. III.
Determine the incidence and severity of acute graft-vs-host disease in patients treated with
this regimen. IV. Determine the incidence of persistent or recurrent CML or MDS in patients
treated with this regimen. V. Determine the safety of this regimen in these patients.

OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -9 to -6
and oral busulfan every 6 hours on days -5 to -2. Patients undergo allogeneic peripheral
blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis
comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine orally or IV twice daily
on days -1 to 100 followed by a taper until day 180. Patients are followed every 6 months
for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia (CML) (BCR/abl or
Philadelphia (Ph) chromosome positive) Accelerated phase More than 10% and less than 30%
myeloblasts and promyelocytes in marrow or peripheral blood Perturbations of white count,
platelet count, or hematocrit uncontrolled by chemotherapy with busulfan or hydroxyurea
Progressive splenomegaly refractory to chemotherapy Extramedullary tumor Presence of a
nonconstitutional cytogenetic abnormality in addition to a single Ph chromosome, except
for -Y Persistent unexplained fever or bone pain Blast phase More than 30% myeloblasts and
promyelocytes in marrow or peripheral blood Remission after blast phase Less than 10%
blasts in marrow and peripheral blood with a history of blast phase Any phase of CML if
there is a contraindication to conditioning therapy with cyclophosphamide OR Diagnosis of
myelodysplastic syndrome (MDS) with any of the following subtypes: Refractory anemia (RA)
or RA with ringed sideroblasts (RARS) High-risk cytogenetics (i.e., monosomy 7 or complex
abnormalities) RA with excess blasts (RAEB) Presence of 5-20% blasts in marrow and less
than 5% blasts in peripheral blood RAEB in transformation 21-30% blasts in marrow OR more
than 5% blasts in peripheral blood Chronic myelomonocytic leukemia Presence of no more
than 20% blasts in marrow, less than 5% blasts in peripheral blood, and more than 1,000
monocytes/uL of peripheral blood Secondary acute myeloid leukemia arising from
pre-existing MDS More than 30% blasts in marrow Any stage of MDS if there is a
contraindication to conditioning therapy with cyclophosphamide Related or unrelated donor
compatible for HLA-A, B, C, DRB1, and DQB1 antigens Mismatch for a single HLA-A, B, C,
DRB1, and DQB1 allele within the same broad serotype (e.g., A*0101 vs 0102) or crossover
group (e.g., A*0101 vs 0301) allowed

PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Not specified Life
expectancy: Not severely limited by diseases other than malignancy Hematopoietic: See
Disease Characteristics Hepatic: No hepatic disease AST no greater than 2 times normal
Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 50% for
age, weight, and height Cardiovascular: No cardiac insufficiency requiring treatment No
symptomatic coronary artery disease Pulmonary: No severe hypoxemia (pO2 less than 70 mm Hg
and DLCO less than 70% predicted) No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less
than 60% predicted) Other: HIV negative Not pregnant or nursing

PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent growth factors during
methotrexate administration

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Claudio Anasetti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1519.00

NCT ID:

NCT00027924

Start Date:

October 2001

Completion Date:

May 2003

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109