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Conditioning With Targeted Busulfan, Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell (PBSC) Transplantation for Myelodysplasia and Myeloproliferative Disorders


Phase 1/Phase 2
N/A
65 Years
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

Conditioning With Targeted Busulfan, Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell (PBSC) Transplantation for Myelodysplasia and Myeloproliferative Disorders


OBJECTIVES:

- Determine the incidence of acute graft-vs-host disease (GVHD) requiring therapy in
patients with myelodysplastic syndromes or myeloproliferative disorders treated with
busulfan, cyclophosphamide, and anti-thymocyte globulin prior to transplantation with
filgrastim (G-CSF)-mobilized peripheral blood stem cells (or bone marrow) from related
or unrelated donors.

- Determine the incidence of relapse and relapse-free survival in patients treated with
this regimen.

- Determine the incidence of non-relapse mortality by day 100 and 1 year
posttransplantation in patients treated with this regimen.

- Determine the incidence of Epstein-Barr virus reactivation, infections, and chronic
GVHD in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of anti-thymocyte globulin.

- Conditioning and graft-vs-host disease (GVHD) prophylaxis: Patients receive oral
busulfan every 6 hours on days -7 to -4 (16 doses), cyclophosphamide IV on days -3 and
-2, and anti-thymocyte globulin IV over 3 hours on days -3, -2, and -1.

Cohorts of 15 patients receive adjusted doses of anti-thymocyte globulin to determine the
optimal dose at which Epstein-Barr virus (EBV) activation and GVHD are reduced. The optimal
dose is the dose at which 2 consecutive cohorts receive the same regimen.

- Stem cell transplantation: Patients undergo peripheral blood stem cell (PBSC) or bone
marrow transplantation on day 0.

- Posttransplantation GVHD prophylaxis: Patients receive cyclosporine IV continuously on
days -1 to 4 and then orally twice daily until day 180. Patients also receive
methotrexate on days 1, 3, 6, and 11.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-45 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Myelodysplastic syndromes (including those that have evolved to acute myeloid
leukemia)

- Myeloproliferative disorders

- No chronic myelogenous leukemia

- Other diseases eligible for conditioning with targeted busulfan,
cyclophosphamide, and anti-thymocyte globulin that are not candidates for other
studies

- Available related or unrelated donor compatible for HLA-A, -B, -C, DRB1, and DQB1

- A single allele mismatch at HLA-A, -B, -C, or DRB1 is allowed

PATIENT CHARACTERISTICS:

Age

- 65 and under

Performance status

- Not specified

Life expectancy

- No severe limitation due to other diseases

Hematopoietic

- Not specified

Hepatic

- AST no greater than 2 times normal

- No hepatic disease

Renal

- Creatinine no greater than 2 times upper limit of normal OR

- Creatinine clearance at least 50% for age, gender, and weight

Cardiovascular

- No cardiac insufficiency requiring treatment

- No symptomatic coronary artery disease

Pulmonary

- No severe or mild hypoxemia

- pO_2 at least 70 mm Hg and DLCO at least 70% of predicted OR

- pO_2 at least 80 mm Hg and DLCO at least 60% of predicted

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No growth factors given posttransplantation concurrently with methotrexate
immunosuppression

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

H. Joachim Deeg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1723.00

NCT ID:

NCT00054340

Start Date:

October 2002

Completion Date:

September 2006

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • graft versus host disease
  • polycythemia vera
  • chronic idiopathic myelofibrosis
  • essential thrombocythemia
  • untreated adult acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent childhood acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • chronic eosinophilic leukemia
  • chronic neutrophilic leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • childhood myelodysplastic syndromes
  • Graft vs Host Disease
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109