Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

Swiss Group for Clinical Cancer Research

Status and phase: Completed; Phase 3

Conditions: Myelodysplastic Syndromes

Treatments: Drug: ATG + CSA; Behavioral: Supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT00004208

SWS-SAKK-33/99 (Other Identifier)

SAKK 33/99

Details and patient eligibility

About

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).

Full 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

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Arm A: ATG + CSA

Active Comparator group

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.

Treatment:

Drug: ATG + CSA

Arm B: Supportive care

Other group

Description:

Patients randomized to this arm will be treated as outpatients.

Treatment:

Behavioral: Supportive care