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

Alternate Title

Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 to 65 NCI FHCRC-1628.00 NCI-H02-0099, NCT00049634

Objectives

1. Determine the incidence of grades II, III, and IV graft-vs-host disease (GVHD) in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia transformed from MDS, or myeloproliferative disorders treated with immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cell transplantation.
2. Determine the incidence of graft failure, relapse, and transplant-related mortality by day 100 in patients treated with this regimen.
3. Determine the incidence of chronic GVHD, in terms of number and duration of immunosuppressant therapies, in patients treated with this regimen.
4. Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral blood stem cells.

Entry Criteria

Disease Characteristics:

• Diagnosis of 1 of the following:
  • Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA)
  • RA with excess blasts (RAEB) (greater than 5% blasts)
  • RAEB in transformation (greater than 20% but less than 30% blasts)
  • Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS
  • Myeloproliferative disorder, including chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis



• No chronic myelogenous leukemia with or without excess (greater than 5%) blasts

• Must have an HLA-identical, related donor

Prior/Concurrent Therapy:

Biologic therapy

• No prior marrow transplantation
• No concurrent growth factors for 21 days after study transplantation

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 18 to 65

Performance status

• Not specified

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)*
• SGOT/SGPT less than 2 times ULN*

 [Note: * Unless due to malignancy]

Renal

• Creatinine no greater than 2.0 mg/dL

  OR

• Glomerular filtration rate at least 60 mL/min

Cardiovascular

• Cardiac ejection fraction at least 45%

Pulmonary

• DLCO at least 60% of predicted

Other

• HIV negative
• Human antimouse antibody negative
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other medical condition that would preclude study participation
• No hypersensitivity to cyclosporine

Expected Enrollment

A total of 30 patients will be accrued for this study within 3 years.

Outcomes

Incidence of grade II, III, and IV graft-versus-host disease

Outline

Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cells are infused on day 0.

Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours (orally twice daily when tolerated) on days -1 to 80 and then gradually tapered over 5 months beginning on day 81.

Patients are followed regularly through day 100 and then at 1 year.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Ann Woolfrey, MD, Protocol chair		Ph: 206-667-4453

U.S.A.
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Ann Woolfrey, MD	Ph:  206-667-4453
	Seattle Cancer Care Alliance
		Clinical Trials Office - Seattle Cancer Care Alliance	Ph:  800-804-8824

Registry Information
Official Title		A Phase I/II Study of Immunologically Engineered rhG-CSF Mobilized Peripheral Blood Stem Cells (PBSC) for Allogeneic Transplant from HLA Identical, Related Donors for Treatment of Myeloid Malignancies
Trial Start Date		2002-01-30
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00049634
Date Submitted to PDQ		2002-09-19
Information Last Verified		2008-12-28
NCI Grant/Contract Number		HL36444, CA15704, CA18029

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