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. - SCT trial

Fresenius Biotech GmbH0 个研究点目标入组 200 人开始时间: 2004年9月14日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•·Patients, 18-55 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).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•·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.

发起方

Fresenius Biotech GmbH