Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

Swiss Cancer Institute86 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndromes

Interventions

ATG + CSADRUG

Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)

Supportive careBEHAVIORAL

Patients randomized to this arm will be treated as outpatients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitaetsspital-Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Best response rate (CR + PR)

Time frame: 6 months

Secondary Outcomes

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

Overall survival

Time frame: 2 and 5 years

Leukemia-free survival

Time frame: 2 and 5 years

Transformation-free survival

Time frame: 2 and 5 years

Data from ClinicalTrials.gov

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