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Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00004208
First received: January 21, 2000
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Myelodysplastic Syndromes
 Drug: ATG + CSA
Behavioral: Supportive care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS). A Randomized Trial Comparing ATG + CSA With Best Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Best response rate (CR + PR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]
  • Leukemia-free survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]
  • Transformation-free survival [ Time Frame: 2 and 5 years ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: August 2000
Study Completion Date: October 2011
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
No Intervention: 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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004208

Locations
Switzerland
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Jakob R. Passweg, MS Kantonsspital Basel
  More Information

Publications:
Passweg JR, Giagounidis A, Simcock M, et al.: Immunosuppression for patients with low and intermediate risk myelodysplastic syndrome: a prospective randomized multicenter trial comparing antithymocyte globulin + cyclosporine with best supportive care: SAKK 33/99. [Abstract] Blood 110 (11): A-1461, 2007.

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00004208     History of Changes
Other Study ID Numbers: SAKK 33/99, SWS-SAKK-33/99
Study First Received: January 21, 2000
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
 de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Antilymphocyte Serum
Cyclosporins
Cyclosporine
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013