Completed

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

What is being tested

ATG + CSA

+ Supportive care

DrugBehavioral

Who is being recruted

Anemia+4

+ Bone Marrow Diseases

+ Hematologic Diseases

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: August 2000

See protocol details

Summary

Principal SponsorSwiss Cancer Institute

Last updated: March 11, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2000

Actual date on which the first participant was enrolled.

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

NCT00004208

Principal SponsorSwiss Cancer Institute

Last updated: March 11, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia, RefractoryAnemia, Refractory, with Excess of BlastsMyelodysplastic Syndromes

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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 II

Patients randomized to this arm will be treated as outpatients.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Universitaetsspital-Basel

Basel, SwitzerlandOpen Universitaetsspital-Basel in Google Maps

CompletedOne Study Center