Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi


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

Thank you

Trial Information

Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi


OBJECTIVES:

- Determine the non-relapse toxicity and mortality on day 100 and at 1 year after
transplantation in patients with low or intermediate-risk myelodysplastic syndrome
treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell
transplantation.

- Determine the incidence of donor stem cell engraftment and relapse-free survival in
these patients treated with this regimen.

- Determine the incidence and severity of acute and chronic graft-versus-host disease and
invasive fungal infections in these patients treated with this regimen.

- Determine the incidence of relapse in these patients treated with this regimen.

OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or
unrelated compatible donor. PBSC are selected for CD34+ cells.

Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on
days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0.

As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day
-1 and continuing orally twice daily (if feasible) until day 51 followed by a taper.
Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Patients are followed through day 100, every 6 months for 2 years, and then annually
thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of low or intermediate-risk myelodysplastic syndrome

- Refractory anemia (RA)

- RA with ringed sideroblasts

- No advanced myelodysplastic syndrome (i.e., at least 5% blasts in the marrow, more
than 1% blasts in the peripheral blood, or blasts in the cerebrospinal fluid)

- No poor-risk cytogenetics (i.e., abnormalities of chromosome 7 or complex
abnormalities)

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

- Mismatch for a single HLA-A, B, C, DRB1, or DQB1 allele allowed

PATIENT CHARACTERISTICS:

Age:

- 65 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- AST no greater than 2 times normal

Renal:

- Creatinine no greater than 2 times upper limit of normal

- Creatinine clearance at least 50%

Cardiovascular:

- No cardiac insufficiency requiring treatment

- No symptomatic coronary artery disease

Pulmonary:

- No severe hypoxemia (pO2 less than 70 mm Hg with DLCO less than 70% predicted)

- No mild hypoxemia (pO2 less than 80 mm Hg with DLCO less than 60% predicted)

Other:

- No other disease that would limit life expectancy

- HIV negative

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

H. Joachim Deeg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1536.00

NCT ID:

NCT00024050

Start Date:

February 2001

Completion Date:

August 2007

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109