Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 65 and under NCI FHCRC-1536.00 NCI-G01-2009, NCT00024050

Objectives

1. 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.
2. Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen.
3. Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen.
4. Determine the incidence of relapse in these patients treated with this regimen.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

H. Joachim Deeg, MD, Protocol chair		Ph: 206-667-5985 Email: jdeeg@fhcrc.org

Registry Information
Official Title		Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
Trial Start Date		2001-02-20
Registered in ClinicalTrials.gov		NCT00024050
Date Submitted to PDQ		2001-07-16
Information Last Verified		2003-10-17
NCI Grant/Contract Number		CA18029, CA15704

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