Back to resultsAntithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome
Primary Purpose
Myelodysplastic Syndromes
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
ATG + CSA
Supportive care
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
Eligibility Criteria
Hypoplastic MDS, or MDS subtype RA, RAS or RAEB with ≤ 10% blasts, or RAEB with 10-20% blasts and the patient refusing or not eligible for the MDS high risk protocol (EORTC 06961) Transfusion dependence < 24 months or neutrophils < 0.5 × 109/l. ECOG/SAKK performance status ≤ 2 Age > 18 years No active uncontrolled infection No prior chemotherapy or radiotherapy No history of heart failure, clinically relevant cardiac arrhythmia or other hemato-oncological disease
Sites / Locations
- Universitaetsspital-Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Arm A: ATG + CSA
Arm B: Supportive care
Arm Description
Treatment consists of 15 mg/kg ATG (Mérieux; horse antithymocyte globulin; i.e. 1.5 vial/10 kg of body weight/day) given over 8-12 hours for 5 consecutive days. Cyclosporine A (CSA) will be administered orally in a dose of 2.5 mg/kg bid starting day 1 and continued through day 180.
Patients randomized to this arm will be treated as outpatients.
Outcomes
Primary Outcome Measures
Best response rate (CR + PR)
Secondary Outcome Measures
Response rate at month 3, time to response, quality and duration of response, and proportions of relapse/progression in responders
Overall survival
Leukemia-free survival
Transformation-free survival
Full Information
NCT ID
NCT00004208
First Posted
January 21, 2000
Last Updated
March 10, 2015
Sponsor
Swiss Group for Clinical Cancer Research
1. Study Identification
Unique Protocol Identification Number
NCT00004208
Brief Title
Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome
Official Title
Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS). A Randomized Trial Comparing ATG + CSA With Best Supportive Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this trial is to evaluate the efficacy and toxicity of intensive immuno-suppression with ATG + CSA versus best supportive care in patients with transfusion dependent low and intermediate risk myelodysplastic syndrome (MDS).
Detailed Description
This trial will answer the question whether immuno-suppression improves hematopoesis and reduces transfusion requirements analogous to patients with aplastic anemia as the short-term outcome, and whether immuno-suppression accelerates leukemic transformation and influences survival as the long-term outcome.
Primary endpoint: best response (CR + PR) rate at month 6
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: ATG + CSA
Arm Type
Active Comparator
Arm Description
Treatment consists of 15 mg/kg ATG (Mérieux; horse antithymocyte globulin; i.e. 1.5 vial/10 kg of body weight/day) given over 8-12 hours for 5 consecutive days.
Cyclosporine A (CSA) will be administered orally in a dose of 2.5 mg/kg bid starting day 1 and continued through day 180.
Arm Title
Arm B: Supportive care
Arm Type
Other
Arm Description
Patients randomized to this arm will be treated as outpatients.
Intervention Type
Drug
Intervention Name(s)
ATG + CSA
Intervention Description
Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)
Intervention Type
Behavioral
Intervention Name(s)
Supportive care
Intervention Description
Patients randomized to this arm will be treated as outpatients.
Primary Outcome Measure Information:
Title
Best response rate (CR + PR)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Response rate at month 3, time to response, quality and duration of response, and proportions of relapse/progression in responders
Time Frame
2 and 5 years after first response
Title
Overall survival
Time Frame
2 and 5 years
Title
Leukemia-free survival
Time Frame
2 and 5 years
Title
Transformation-free survival
Time Frame
2 and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Hypoplastic MDS, or MDS subtype RA, RAS or RAEB with ≤ 10% blasts, or RAEB with 10-20% blasts and the patient refusing or not eligible for the MDS high risk protocol (EORTC 06961)
Transfusion dependence < 24 months or neutrophils < 0.5 × 109/l.
ECOG/SAKK performance status ≤ 2
Age > 18 years
No active uncontrolled infection
No prior chemotherapy or radiotherapy
No history of heart failure, clinically relevant cardiac arrhythmia or other hemato-oncological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob R. Passweg, MS
Organizational Affiliation
Kantonsspital Basel
Official's Role
Study Chair
Facility Information:
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21149672
Citation
Passweg JR, Giagounidis AA, Simcock M, Aul C, Dobbelstein C, Stadler M, Ossenkoppele G, Hofmann WK, Schilling K, Tichelli A, Ganser A. Immunosuppressive therapy for patients with myelodysplastic syndrome: a prospective randomized multicenter phase III trial comparing antithymocyte globulin plus cyclosporine with best supportive care--SAKK 33/99. J Clin Oncol. 2011 Jan 20;29(3):303-9. doi: 10.1200/JCO.2010.31.2686. Epub 2010 Dec 13.
Results Reference
result
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Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome
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