Overview
Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT)
Status:
Completed
Completed
Trial end date:
2009-03-01
2009-03-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Neovii BiotechCollaborator:
University Medical Center FreiburgTreatments:
CyclosporineCyclosporins
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.