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

NCT00049634 | Completed Phase 1

• 4 other identifiers: 1628.00FHCRC-1628.00NCI-H02-0099CDR0000258137
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Interventions

busulfan DRUG

cyclophosphamide DRUG

cyclosporine DRUG

methotrexate DRUG

in vitro-treated peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelomonocytic, Chronic; Thrombocythemia, Essential; Polycythemia Vera; Anemia, Refractory, with Excess of Blasts; Pdgfra-Associated Chronic Eosinophilic Leukemia; Leukemia, Neutrophilic, Chronic; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Busulfan; Cyclophosphamide; Cyclosporine; Methotrexate

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ann E. Woolfrey, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: February 1, 2007
• Last Updated: September 16, 2010

Record last verified: 2010-09

Locations

US (2)