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Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
This study has been completed.
Study NCT00024050   Information provided by Fred Hutchinson Cancer Research Center
First Received: September 13, 2001   Last Updated: July 2, 2009   History of Changes

September 13, 2001
July 2, 2009
February 2001
August 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00024050 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.

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.

Phase II
Interventional
Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Drug: busulfan
  • Drug: cyclophosphamide
  • Drug: cyclosporine
  • Drug: methotrexate
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
up to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00024050
 
CDR0000068887, FHCRC-1536.00, NCI-G01-2009
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: H. Joachim Deeg, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP