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


Phase 3
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

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Trial Information

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


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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best response rate (CR + PR)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jakob R. Passweg, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital Basel

Authority:

Switzerland: Swissmedic

Study ID:

SAKK 33/99

NCT ID:

NCT00004208

Start Date:

August 2000

Completion Date:

October 2011

Related Keywords:

  • Myelodysplastic Syndromes
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • Myelodysplastic Syndromes
  • Preleukemia

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