Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

Phase 3

Completed

• Conditions: Myelodysplastic Syndromes
• Interventions: Behavioral: Supportive care; Drug: ATG + CSA

• Registration Number: NCT00004208
• Lead Sponsor: Swiss Group for Clinical Cancer Research

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

Study Timeline

• Study First Submitted: 2000-01-21
• Study Start: 2000-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-10
• Study Completion: 2011-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm B: Supportive care	Supportive care	Patients randomized to this arm will be treated as outpatients.
Arm A: ATG + CSA	ATG + CSA	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.

Primary Outcome Measures

Name	Time	Method
Best response rate (CR + PR)	6 months

Secondary Outcome Measures

Name	Time	Method
Leukemia-free survival	2 and 5 years
Response rate at month 3, time to response, quality and duration of response, and proportions of relapse/progression in responders	2 and 5 years after first response
Overall survival	2 and 5 years
Transformation-free survival	2 and 5 years

Trial Locations

Locations (1)

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland