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Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
First Received: June 6, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Sangstat Medical Corporation
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00017550
  Purpose

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.


Condition Intervention Phase
Myelodysplastic Syndromes
Biological: anti-thymocyte globulin
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: An Open Label, Prospective, Stratified, Randomized, Controlled, Multi-Center, Phase IIB Study of the Impact of Thymoglobulin Therapy on Transfusion Needs of Patients With Early Myelodysplastic Syndrome (MDS)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2001
Detailed Description:

OBJECTIVES:

  • Compare the clinical response rate of patients with early myelodysplastic syndrome treated with rabbit anti-thymocyte globulin vs standard supportive care.
  • Evaluate the safety of anti-thymocyte globulin in these patients.
  • Compare the time to and duration of clinical response, rates of partial response and therapy failure, and rate of disease progression in patients treated with these regimens.
  • Compare the ECOG performance score, number of transfusions and/or growth factor use, and maximum time between transfusions in patients treated with these regimens.
  • Compare the infection risk, use of medical resources, and quality of clinical response in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to myelodysplastic syndrome (MDS) subtype (refractory anemia (RA) vs RA with excess blasts or hypocellular MDS). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive rabbit anti-thymocyte globulin (ATG) IV over at least 8-12 hours on days 1-4.
  • Arm II: Patients receive standard supportive therapy for 6 months. At the end of 6 months, patients may receive ATG as in arm I.

Patients are followed for 6 months.

PROJECTED ACCRUAL: A total of 72 patients (48 in arm I and 24 in arm II) will be accrued within a minimum of 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017550

  Hide Study Locations
Locations
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0296
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush Cancer Institute
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Blood and Marrow Transplant
Beech Grove, Indiana, United States, 46107
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Missouri
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110-2539
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
University of Missouri Kansas City School of Medicine
Kansas City, Missouri, United States, 64111
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
New York Medical College
Valhalla, New York, United States, 10595
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Texas
Texas Oncology P.A.
Dallas, Texas, United States, 75230-2503
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226-3596
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Department of Medicine
Vancouver, British Columbia, Canada, V5Z 4E3
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Sangstat Medical Corporation
Investigators
Study Chair: Elizabeth C. Squiers, MD Sangstat Medical Corporation
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068709, SMC-101-1020, RUSH-MDS-2000-04
Study First Received: June 6, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00017550     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory anemia
refractory anemia with excess blasts
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes

Additional relevant MeSH terms:
Disease
Precancerous Conditions
Immunologic Factors
Hematologic Diseases
Myelodysplastic Syndromes
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Antilymphocyte Serum
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 27, 2009