Conditions

Keywords

refractory anemiarefractory anemia with excess blastsde novo myelodysplastic syndromespreviously treated myelodysplastic syndromes

Interventions

anti-thymocyte globulinBiological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed early myelodysplastic syndrome (MDS) with less than 10% bone marrow blasts * Refractory anemia (RA) * RA with excess blasts (RAEB) * Hypocellular myelodysplasia * Low or intermediate-1 prognostic risk * Transfusion-dependent * Need for 2 or more units of red blood cells or platelets per month for 2 or more months prior to study OR * History of prior transfusions and 2 consecutive (at least 21 days apart) hemoglobin levels less than 8.0 g/dL or platelet counts less than 20,000/mm\^3 during the past 2 months * Hemoglobin no greater than 12.0 g/dL after prior transfusion * No myelosclerosis occupying more than 30% of bone marrow space * No RA with ringed sideroblasts, RAEB in transformation, or chronic myelomonocytic leukemia * No therapy-related MDS * No history of immune-related hematologic disorder (e.g., idiopathic thrombocytopenic purpura) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * See Disease Characteristics * No other causes of cytopenia unrelated to MDS (e.g., gastrointestinal blood loss) * Iron present on marrow examination OR * Transferrin saturation at least 20% and ferritin at least 50 ng/mL Hepatic: * Bilirubin no greater than 2 mg/dL OR * SGOT/SGPT no greater than 2 times normal * No active or chronic hepatitis B or C Renal: * Creatinine no greater than 2 mg/dL Cardiovascular: * No symptomatic cardiac disease * No congestive heart failure (even if medically controlled) * No myocardial infarction within the past 6 months Pulmonary: * No severe pulmonary disease * If history of pulmonary insufficiency, must have pO\_2 at least 90 mm/Hg on room air or pCO\_2 no greater than 40 mm/Hg Other: * No history of unresolved B12 or folate deficiency since diagnosis of MDS * No untreated acute or chronic infection (afebrile for 7 days without antibiotics prior to study) * No active or chronic HIV * No concurrent cytomegalovirus infection * No other malignancy within the past 2 years except adequately treated localized squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * No concurrent drug or alcohol abuse * No significant medical or psychosocial problems * No known allergy to rabbit protein * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 8 weeks since prior biologic agents, colony-stimulating factors, or epoetin alfa for MDS * At least 8 weeks since other prior investigational biologic agents * No prior or concurrent bone marrow transplantation * No concurrent epoetin alfa * No concurrent growth factors except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenic fevers * No other concurrent biologic agents Chemotherapy: * At least 8 weeks since prior cytotoxic drugs for MDS * Concurrent chemotherapy for clinical indications of disease progression or leukemic transformation allowed Endocrine therapy: * At least 8 weeks since prior androgenic hormonal therapy for MDS * At least 8 weeks since prior danazol for MDS Radiotherapy: * No prior radiotherapy Surgery: * No prior organ transplantation Other: * At least 8 weeks since prior investigational drugs * At least 8 weeks since prior immunosuppressive drugs or other drugs for MDS * No concurrent immunosuppressive therapy * No other concurrent experimental drugs

Sponsors & Collaborators

Genzyme, a Sanofi Company
Industrylead

Study Sites (28)

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

University of Florida Health Science Center

Gainesville, Florida, 32610-0296, United States

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Rush Cancer Institute

MeSH Terms

Conditions

Myelodysplastic SyndromesAnemia, RefractoryAnemia, Refractory, with Excess of Blasts

Interventions

Antilymphocyte Serum

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood Proteins

Study Officials

Elizabeth C. Squiers, MD
Sangstat Medical Corporation
STUDY CHAIR

Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (28)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (28)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations