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 个研究点目标入组 202 人开始时间: 2008年8月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•- 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.

发起方

eovii Biotech GmbH