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Sponsors and Collaborators: |
Fresenius Biotech GmbH Zentrum Klinische Studien/Center for Clinical Trials (ZKS/CCT) |
Information provided by: | Fresenius Biotech GmbH |
ClinicalTrials.gov Identifier: | NCT00655343 |
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.
Condition | Intervention | Phase |
Graft vs Host Disease |
Drug: ATG-Fresenius S |
Phase III |
ChemIDplus related topics: | Methotrexate Cyclosporine Cyclosporin Globulin, Immune Immunoglobulins Sodium chloride |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | GvHD Prophylaxis With ATG-Fresenius S in Allogeneic Stem Cell Transplantation From Matched Unrelated Donors: A Randomized Phase III Multicenter Trial Comparing a Standard GvHD Prophylaxis With Cyclosporine A and Methotrexate With Additional Pretransplant ATG-Fresenius S |
Enrollment: | 202 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
ATG-Fresenius S (20 mg/kg body weight at days -3 to -1 (total dose: 60 mg/kg) cyclosporine A (target trough level > 200ng/ml (day -1 until day +100) methotrexate: 15mg/m2 at day +1, 10mg/m2 at days +3, +6, and +11 |
Drug: ATG-Fresenius S
20 mg rabbit immunoglobulin (IgG) in 1 ml of sterile solution 20 mg/kg body weight per day diluted in 500 ml physiological saline, slow intravenous infusion at days -3, -2, -1 prior to transplantation |
2: No Intervention
cyclosporine A (target trough level > 200ng/ml (day -1 until day +100) methotrexate: 15mg/m2 at day +1, 10mg/m2 at days +3, +6, and +11 |
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 III-IV or early mortality within 100 days post transplantation compared to standard therapy alone.
All patients receive myeloablative therapy. Recommended regimens: For patients with ALL: fractionated TBI (8-12 Gy) plus cyclophosphamide (1-2 x 60 mg/kg) [etoposide/melfalan are also allowed]. For all other indications: either TBI (8-12 Gy) or busulfan (per os 14-16 mg/kg b.w. or equivalent for IV administration) plus cyclophosphamide (1-2 x 60 mg/kg) or thiotepa ≥ 15 mg/kg or BCNU ≥ 300 mg/m2.
Conditioning regimens may differ from centre to centre; each centre decides for constant (disease specific) regimen(s) throughout the whole study period.
Standard GvHD prophylaxis consists of cyclosporine A (target trough level ≥ 200 ng/ml starting from day -1 until day +100) and short course methotrexate (15 mg/m2 at day +1, 10 mg/m2 at days +3, +6 and +11).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participation of patients in simultaneous diagnostic and comprehensive therapeutical trials for certain entities is allowed.
Patients suffering from one of the following diseases:
Exclusion Criteria:
Germany, Baden-Württemberg | |||||
Universität Freiburg, Medizinische Klinik, Abteilung Innere Medizin I, Hämatologie/Onkologie | |||||
Freiburg, Baden-Württemberg, Germany, 79110 |
Fresenius Biotech GmbH |
Zentrum Klinische Studien/Center for Clinical Trials (ZKS/CCT) |
Principal Investigator: | Juergen Finke, Prof. Dr. | Albert-Ludwigs-University Freiburg |
Study ID Numbers: | AP-AS-21-DE |
First Received: | April 3, 2008 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00655343 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
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