Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004208
• Other study ID #: SAKK 33/99
• Secondary ID: SWS-SAKK-33/99
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2000
• Last updated: March 10, 2015
• Start date: August 2000
• Est. completion date: October 2011

Study information

• Verified date: March 2015
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2011
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• ATG + CSA
Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)

Behavioral:
• Supportive care
Patients randomized to this arm will be treated as outpatients.

Locations

Country	Name	City	State
Switzerland	Universitaetsspital-Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 tri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best response rate (CR + PR)		6 months	No
Secondary	Response rate at month 3, time to response, quality and duration of response, and proportions of relapse/progression in responders		2 and 5 years after first response	No
Secondary	Overall survival		2 and 5 years	No
Secondary	Leukemia-free survival		2 and 5 years	No
Secondary	Transformation-free survival		2 and 5 years	No