AML, ALL, MDS, CML
Conditions
Interventions
Trade Name: ATG-Fresenius S
Product Name: ATG-Fresenius S
Product Code: Anti-T-lymphocyte globulin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rabbit Immunoglobulin
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare standard GvHD prophylaxis consisting of cyclosporine A and methotrexate with standard GvHD prophylaxis plus pre-transplant ATG-FRESENIUS S with respect to efficacy and safety.;Secondary Objective: Time to onset of acute GvHD (grade I-IV, II-IV, III-IV), incidence and severity of infections until day +100, time to engraftment, incidence of chronic GvHD (limited and extensive, extensive) over time, disease free survival, incidence of relapse over time, incidence of death without relapse over time, overall survival, safety and tolerability.;Primary end point(s): Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation. | — |
Countries
Finland, Italy, Spain
Outcome results
None listed