Status:
COMPLETED
Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT)
Lead Sponsor:
Neovii Biotech
Collaborating Sponsors:
University Medical Center Freiburg
Conditions:
Graft vs Host Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 met...
Detailed Description
To assess the efficacy of ATG-FRESENIUS S in addition to standard therapy (cyclosporine A / methotrexate) with respect to early treatment failure defined by the occurrence of severe acute GvHD grade I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00655343
Start Date
February 1 2003
End Date
March 1 2009
Last Update
December 12 2011
Active Locations (1)
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1
Universität Freiburg, Medizinische Klinik, Abteilung Innere Medizin I, Hämatologie/Onkologie
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79110