NCT00017550

Brief Summary

RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be effective treatment for myelodysplastic syndrome. It is not yet known whether immunosuppressive therapy is more effective than supportive care in treating myelodysplastic syndrome. PURPOSE: Randomized phase II trial to compare the effectiveness of antithymocyte globulin with that of supportive care in treating patients who have myelodysplastic syndrome.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2000

Typical duration for phase_2

Geographic Reach
2 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
Last Updated

January 27, 2021

Status Verified

March 1, 2003

Enrollment Period

3.2 years

First QC Date

June 6, 2001

Last Update Submit

January 24, 2021

Conditions

Myelodysplastic Syndromes

Keywords

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

Interventions

anti-thymocyte globulinBIOLOGICAL

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

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

Sponsors & Collaborators

Study Sites (28)

Washington Cancer Institute

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

Location

University of Florida Health Science Center

Gainesville, Florida, 32610-0296, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Veterans Affairs Medical Center - Tampa (Haley)

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Rush Cancer Institute

Chicago, Illinois, 60612, United States

Location

Indiana Blood and Marrow Transplant

Beech Grove, Indiana, 46107, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

University of Missouri Kansas City School of Medicine

Kansas City, Missouri, 64111, United States

Location

Saint Louis University Cancer Center

St Louis, Missouri, 63110-2539, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Texas Oncology P.A.

Dallas, Texas, 75230-2503, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3596, United States

Location

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

Department of Medicine

Vancouver, British Columbia, V5Z 4E3, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

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 ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

  • Elizabeth C. Squiers, MD

    Sangstat Medical Corporation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

September 1, 2000

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

January 27, 2021

Record last verified: 2003-03

Locations

CA(3)US(25)