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Home > "A" Clinical Trials Conditions > Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome  Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome
Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome
For Condition: de novo myelodysplastic syndromes,refractory anemia with excess blasts,Refractory Anemia,refractory anemia with ringed sideroblasts,previously treated myelodysplastic syndromes,secondary myelodysplastic syndromes
Status: Recruiting
Sponsor(s): Swiss Institute for Applied Cancer Research ,
Synopsis: RATIONALE: Antithymocyte globulin and cyclosporine may improve blood counts in patients with myelodysplastic syndrome. It is not yet known whether antithymocyte globulin and cyclosporine are more effective than standard therapy for myelodysplastic syndrome. PURPOSE: Randomizedphase III trial to compare the effectiveness of antithymocyte globulin and cyclosporine with that of standard therapy in treating patients who have myelodysplastic syndrome.
Details: OBJECTIVES: - Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine versus best supportive care in patients with transfusion dependent low or intermediate risk myelodysplastic syndrome. - Determine whether immunosuppression improves hematopoiesis and reduces transfusion requirements of these patients. - Determine whether immunosuppression accelerates leukemic transformation and influences survival of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and risk group. Patients are randomized to 1 of 2 treatment arms: - Arm I: Patients receive antithymocyte globulin IV over 3 hours on days 1-5 and oral cyclosporine twice daily on days 1-180. - Arm II: Patients receive standard supportive care without antithymocyte globulin and cyclosporine. Patients are followed at 1, 3, and 6 months, then every 6 months for 1.5 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 84 patients (42 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) of less than 2 years duration with any of the following: - Hypoplasia - Refractory anemia - Refractory anemia with sideroblasts - Refractory anemia with excess of blasts (RAEB) with no greater than 10% blast cells in bone marrow - RAEB with 10-20% blast count, and patient refuses intensive chemotherapy on high risk MDS protocol (EORTC 06961) and is not eligible for bone marrow transplantation - Transfusion dependence, defined by any of the following: - Packed red blood cell transfusions greater than 2 units per month for a period of at least 2 months - Untransfused hemoglobin level no greater than 8 g/dL - Platelet transfusions greater than 1 unit per 2 weeks for a period of greater than 1 month - Untransfused platelet count no greater than 20,000/mm^3 - No chronic myelomonocytic leukemia - No refractory anemia with excess blasts in transformation - Not scheduled for a bone marrow transplantation PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG/SAKK 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 2.5 times upper limit of normal (ULN) - No active chronic hepatitis B or C Renal: - Creatinine no greater than 2.5 times ULN Cardiovascular: - No history of heart failure - No clinically relevant cardiac arrhythmia Other: - No other prior malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix - No history of allergy to horse proteins, anaphylactic reactions to animal proteins, or serum sickness - Not pregnant - Fertile patients must use effective contraception - HIV negative - No active uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
A.Tichelli, Study Chair, Universitatsklinken Basel
Universitatsklinken Basel *Recruiting*
Basel, , CH-4031
Switzerland
Recruiting A. Tichelli 41-61-265-4254
Additional Information:
Study ID Numbers: CDR0000067455; SWS-SAKK-33/99,EU-99029
Study Start Date:
Record last reviewed: May 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004208
Other Previously Treated Myelodysplastic Syndromes Studies:
1. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
2. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
3. Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
4. Thalidomide in Treating Patients With Myelodysplastic Syndrome
5. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other previously treated myelodysplastic syndromes Clinical Trials
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Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome
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