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

This study has been completed.
Sponsor:
Collaborator:
University Medical Center Freiburg - Clinical Trials Unit
Information provided by (Responsible Party):
Neovii Biotech
ClinicalTrials.gov Identifier:
NCT00655343
First received: April 3, 2008
Last updated: December 9, 2011
Last verified: December 2011

April 3, 2008
December 9, 2011
February 2003
March 2007   (final data collection date for primary outcome measure)
Primary: Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation. [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00655343 on ClinicalTrials.gov Archive Site
Time to onset of acute GvHD, incidence and severity of infections until day +100, time to engraftment, incidence of cGvHD, disease free survival, relapse, death without relapse, overall survival, safety, tolerability. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT)
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

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Graft vs Host Disease
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

Other Names:
  • ATG-Fresenius
  • Anti-T-Lymphocyte globulin
  • Experimental: ATG-F

    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

    Intervention: Drug: ATG-Fresenius S
  • No Intervention: non-ATG-F

    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


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
March 2009
March 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00655343
AP-AS-21-DE
Yes
Neovii Biotech
Neovii Biotech
University Medical Center Freiburg - Clinical Trials Unit
Principal Investigator: Juergen Finke, Prof. Dr. Albert-Ludwigs-University Freiburg
Neovii Biotech
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP