DRKS00000002
Completed
Phase 3
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
eovii Biotech GmbH0 sites202 target enrollmentStarted: August 8, 2008Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- eovii Biotech GmbH
- Enrollment
- 202
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (—)
- Sex
- All
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);
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.
Investigators
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