Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelodysplastic Syndromes
Intervention: anti-thymocyte globulin (Biological)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Sangstat Medical Corporation Official(s) and/or principal investigator(s): Elizabeth C. Squiers, MD, Study Chair, Affiliation: Sangstat Medical Corporation
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.
Clinical Details
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)
Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 and Contacts
Foothills Hospital, Calgary, Alberta T2N 2T9, Canada
Department of Medicine, Vancouver, British Columbia V5Z 4E3, Canada
Washington Cancer Institute, Washington, 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, Chicago, Illinois 60612, United States
Indiana Blood and Marrow Transplant, Beech Grove, Indiana 46107, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa 52242-1009, United States
University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States
Tulane University School of Medicine, New Orleans, Louisiana 70112, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
University of Missouri Kansas City School of Medicine, Kansas City, Missouri 64111, United States
Saint Louis University Cancer Center, Saint Louis, Missouri 63110-2539, United States
Siteman Cancer Center, Saint Louis, Missouri 63110, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States
Hackensack University Medical Center, Hackensack, New Jersey 07601, United States
Mount Sinai Medical Center, NY, New York, New York 10029, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York 10021, United States
James P. Wilmot Cancer Center, Rochester, New York 14642, United States
New York Medical College, Valhalla, New York 10595, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada
Texas Oncology P.A., Dallas, Texas 75230-2503, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226-3596, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 2001
Last updated: February 6, 2009
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