Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2011-10-31

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Myelodysplastic Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: 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.

Group Type ACTIVE_COMPARATOR

ATG + CSA

Intervention Type DRUG

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

Arm B: Supportive care

Patients randomized to this arm will be treated as outpatients.

Group Type OTHER

Supportive care

Intervention Type BEHAVIORAL

Patients randomized to this arm will be treated as outpatients.

Interventions

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ATG + CSA

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

Intervention Type DRUG

Supportive care

Patients randomized to this arm will be treated as outpatients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No