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

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049634

Purpose

RATIONALE: Giving chemotherapy drugs before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored.

PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or myeloproliferative disorder.

Condition	Intervention	Phase
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases	Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: in vitro-treated peripheral blood stem cell transplantation	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclophosphamide Busulfan Methotrexate Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence of grade II, III, and IV graft-versus-host disease [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2002
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.
Determine the incidence of graft failure, relapse, and transplant-related mortality by day 100 in patients treated with this regimen.
Determine the incidence of chronic GVHD, in terms of number and duration of immunosuppressant therapies, in patients treated with this regimen.
Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral blood stem cells.

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.

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049634

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Ann E. Woolfrey, MD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Fred Hutchinson Cancer Research Center ( Ann E. Woolfrey )
Study ID Numbers:	CDR0000258137, FHCRC-1628.00, NCI-H02-0099
Study First Received:	November 12, 2002
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00049634 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

chronic myelomonocytic leukemia
de novo myelodysplastic syndromes
essential thrombocythemia
polycythemia vera
previously treated myelodysplastic syndromes
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation

secondary acute myeloid leukemia
secondary myelodysplastic syndromes
chronic eosinophilic leukemia
chronic neutrophilic leukemia
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Cyclophosphamide
Leukemia, Myeloid, Acute
Cyclosporins
Leukemia
Preleukemia

Pathologic Processes
Antifungal Agents
Syndrome
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Disease
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 25, 2009