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Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004208
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Tracking Information
First Submitted Date  ICMJE January 21, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE August 2000
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
Best response rate (CR + PR) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • 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 ]
  • Overall survival [ Time Frame: 2 and 5 years ]
  • Leukemia-free survival [ Time Frame: 2 and 5 years ]
  • Transformation-free survival [ Time Frame: 2 and 5 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome
Official Title  ICMJE Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS). A Randomized Trial Comparing ATG + CSA With Best Supportive Care
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndromes
Intervention  ICMJE
  • Drug: ATG + CSA
    Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)
  • Behavioral: Supportive care
    Patients randomized to this arm will be treated as outpatients.
Study Arms  ICMJE
  • 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.

    Intervention: Drug: ATG + CSA
  • Arm B: Supportive care
    Patients randomized to this arm will be treated as outpatients.
    Intervention: Behavioral: Supportive care
Publications * Passweg JR, Giagounidis AA, Simcock M, Aul C, Dobbelstein C, Stadler M, Ossenkoppele G, Hofmann WK, Schilling K, Tichelli A, Ganser A. Immunosuppressive therapy for patients with myelodysplastic syndrome: a prospective randomized multicenter phase III trial comparing antithymocyte globulin plus cyclosporine with best supportive care--SAKK 33/99. J Clin Oncol. 2011 Jan 20;29(3):303-9. doi: 10.1200/JCO.2010.31.2686. Epub 2010 Dec 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2012)
86
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004208
Other Study ID Numbers  ICMJE SAKK 33/99
SWS-SAKK-33/99 ( Other Identifier: SAKK )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swiss Group for Clinical Cancer Research
Study Sponsor  ICMJE Swiss Group for Clinical Cancer Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jakob R. Passweg, MS Kantonsspital Basel
PRS Account Swiss Group for Clinical Cancer Research
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP