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

NCT00024050 | Completed Phase 2

• 4 other identifiers: 1536.00FHCRC-1536.00NCI-G01-2009CDR0000068887
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

refractory anemia; refractory anemia with ringed sideroblasts; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; childhood myelodysplastic syndromes

Interventions

busulfan DRUG

cyclophosphamide DRUG

cyclosporine DRUG

methotrexate DRUG

allogeneic bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 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 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified 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 (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory

Interventions

Busulfan; Cyclophosphamide; Cyclosporine; Methotrexate; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; 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; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• H. Joachim Deeg, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Study Completion: August 1, 2007
• Last Updated: May 13, 2010

Record last verified: 2010-05

Locations

US (1)