GvHD prophylaxis with ATG-Fresenius S in allogeneic Stem Cell Transplantation from matched unrelated donors:A randomised phase III multicenter trial comparing a standard GvHD prophylaxis with cyclosporine A and methotrexate with additional pretransplant ATG-FRESENIUS S

Phase 3

• Conditions: GvHD prophylaxis; C95; Leukaemia of unspecified cell type

• Registration Number: DRKS00000002
• Lead Sponsor: eovii Biotech GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-08
• Study Completion: 2015-02-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Patients, 18-60 years of age;
- Patients suffering from one of the following diseases:
- AML: 1st complete remission, beyond 1st remission, in relapse not in remission (induction failure, primary refractory);
- ALL: 1st complete remission, beyond 1st remission, in relapse not in remission (induction failure, primary refractory);
- MDS: RA (with poor risk factors as classified by the International Prognostic Scoring System of MDS), RARS, RAEB, RAEB-t, CMML;
- CML: beyond 1st chronic phase: accelerated phase, blast crisis, chronic phase (CP) 2, CP 3;
- Patients designated to undergo allogeneic bone marrow transplantation or allogeneic peripheral blood stem cell transplantation;
- Patients with an HLA-A, -B (serologic and DNA-based), HLA-DRB1, -DQB1 (high DNA-based resolution) matched (8 out of 8 alleles) unrelated donor;
- Patients with a Karnofsky Performance Score (KPS): ? 60%;
- Patients who underwent all obligatory screening examinations (special examinations within the last 4 weeks);
- Patients who have given their written informed consent to participate in the study.

Exclusion Criteria

- Patients with significant cardiac, renal, metabolic and/or CNS disease, currently uncontrolled by treatment, which may interfere with the completion of the study;
- Patients with any bacterial, viral, or fungal infections not under adequate antimicrobial control;
- Patients who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs-Ag), or Hepatitis C antibody, or who are known to have a positive result to the test of HIV antibodies;
- Patients with any additional concurrent or previous malignant disease;
- Patients with known hypersensitivity to rabbit immunoglobulin antibodies in past patient history or with known allergy to any substance chemically related to the study medication;
- Pregnant or lactating women;
- Patients who formerly underwent transplantation;
- Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the appearance of acute GvHD (Level III-IV) and premature mortality in the first 100 days following transplantation.

Secondary Outcome Measures

Name	Time	Method
Time to onset of acute GvHD (grade I-IV, II-IV, III-IV), incidence and severity of infections until<br>day +100, time to engraftment, incidence of chronic GvHD (limited and extensive, extensive) over time,<br>disease free survival, incidence of relapse over time, incidence of death without relapse over time, overall<br>survival, safety and tolerability.