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Completed

NCT Number: NCT00004208

Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

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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Key information

Conditions

Myelodysplastic Syndromes Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATG + CSA

Drug

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

Supportive Care

Behavioral

Patients randomized to this arm will be treated as outpatients.

Primary outcomes

  1. Best response rate (CR + PR)

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. Overall survival

    Time frame: 2 and 5 years

  3. Leukemia-free survival

    Time frame: 2 and 5 years

  4. Transformation-free survival

    Time frame: 2 and 5 years

Sponsors and collaborators

Lead sponsor

Swiss Cancer Institute

Other

Registry information

Official study title

Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS). A Randomized Trial Comparing ATG + CSA With Best Supportive Care

Important dates

Study start
2000
Primary completion
2006
Study completion
2011
First posted
Jan 27, 2003
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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