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

Primary Purpose

Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
busulfan
cyclophosphamide
cyclosporine
methotrexate
in vitro-treated peripheral blood stem cell transplantation
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center
  • Seattle Cancer Care Alliance

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 12, 2002
Last Updated
September 14, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00049634
Brief Title
Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Procedure
Intervention Name(s)
in vitro-treated peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Incidence of grade II, III, and IV graft-versus-host disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann E. Woolfrey, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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