Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

March 10, 2015 updated by: Swiss Group for Clinical Cancer Research

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4031
        • Universitaetsspital-Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: ATG + CSA
Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)
Other: Arm B: Supportive care
Patients randomized to this arm will be treated as outpatients.
Behavioral: Supportive care
Patients randomized to this arm will be treated as outpatients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best response rate (CR + PR)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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 and 5 years after first response
Overall survival
Time Frame: 2 and 5 years
2 and 5 years
Leukemia-free survival
Time Frame: 2 and 5 years
2 and 5 years
Transformation-free survival
Time Frame: 2 and 5 years
2 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

  • Study Chair: Jakob R. Passweg, MS, Kantonsspital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 33/99
  • SWS-SAKK-33/99 (Other Identifier: SAKK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myelodysplastic Syndromes

Clinical Trials on ATG + CSA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe