Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aim is to evaluate the influence of the anti-T-lymphocyte globulin ATG-Fresenius S given pre-transplant in addition to standard GvHD prophylaxis with cyclosporine A and a short course of methotrexate with respect to efficacy and safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neovii Biotech
• Collaborator: University Medical Center Freiburg
• Treatments: Cyclosporine; Cyclosporins; Methotrexate

Criteria

Inclusion Criteria:

Participation of patients in simultaneous diagnostic and comprehensive therapeutical trials for certain entities is allowed.

• Patients 18-60 years of age;

• Patients suffering from one of the following diseases:

• AML: 1st complete remission (CR1) or beyond 1st remission (CR2, CR3), in relapse, not in remission (primary refractory, induction failure);

• ALL: 1st complete remission (CR1) or beyond 1st remission (CR2, CR3), in relapse, not in remission (primary refractory, induction failure);

• MDS, if transplantation is medically indicated: 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 (CP1): accelerated phase, blast crisis, chronic phase (CP2, CP3);

• OMF, if transplantation is medically indicated: Osteomyelofibrosis;

• Patients designated to undergo allogeneic bone marrow transplantation or allogeneic peripheral blood stem cell transplantation;

• Patients with a HLA-A, -B (DNA-based, 2 digits), HLA-DRB1, -DQB1 (DNA-based 4 digits) matched (8 out of 8 alleles) unrelated donor; serological typing is not required

• 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 (e.g. ejection fraction <50%), pulmonary (e.g. FEV1 <50%), renal (e.g. creatinine > 1.5 mg/dl), metabolic (e.g. bilirubin > 2.0 mg/dl) 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 (β-HCG test) or lactating women;

• Patients who formerly underwent transplantation including previous autologous transplants;

• Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the study.