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

CompletedPhase 2

Sponsor: Genzyme, a Sanofi Company

Conditions: Myelodysplastic Syndromes

Interventions: anti-thymocyte globulin

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (28)

Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Beech Grove, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Valhalla, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Dallas, Texas, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada