Status:
WITHDRAWN
Anti-CD3 & Anti-CD7 Ricin A Immunotoxin-Combination for Acute Graft Versus Host Disease
Lead Sponsor:
Henogen
Conditions:
Acute Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
In this study, a combination of two T-cell directed antibodies both conjugated to a cell-killing toxin will be evaluated. Previous in vitro studies have demonstrated that this so-called immunotoxin-co...
Detailed Description
"The experimental design is a non-controlled multicentric fixed-dose Phase I/II study. A total of 12 evaluable patients will be enrolled in 4 transplant centers throughout the Netherlands, in a 9 to 1...
Eligibility Criteria
Inclusion
- Patients suffering from severe acute GVHD (Grade II-IV) progressing after 3 days, or non-improving after 5 days, of prednisolone at 2 mg/kg a day.
- Age ≥ 18 years.
- Patients or their guardians should have given written informed consent using forms approved by the Institutional Review Board.
Exclusion
- Patients receiving concomitant investigational therapeutics/prophylaxis for acute GVHD at the time of enrollment.
- Patients with histological signs/symptoms suggestive of chronic GVHD.
- Patients requiring mechanical ventilation, requiring vasopressor support, requiring hemodialysis, having serum creatinine \> 266 μmol/l (\> 3 mg/dl), or having a serum albumin level of 20 g/l or less.
- Patients having uncontrolled bacterial, viral or fungal infections at the start of therapy.
- Patients with current evidence of active intrapulmonary disease.
- Patients with known hypersensitivity to any of the components of the study drug (murine mAb or RTA).
- Patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00640497
Start Date
January 1 2010
End Date
January 1 2012
Last Update
April 29 2009
Active Locations (3)
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1
Department of Hematology Radboud University Nijmegen (RUN)
Nijmegen, Netherlands, 6525 GA
2
Department of Hematology Erasmus MC/Daniel den Hoed Cancer CenterGroene Hilledijk
Rotterdam, Netherlands, 3153075 EA
3
L.F. , Department of HematologyUMC Utrecht
Utrecht, Netherlands, 1003584 CX