Carfilzomib for the Prevention of Graft Versus Host Disease
|ClinicalTrials.gov Identifier: NCT01991301|
Recruitment Status : Unknown
Verified December 2015 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Graft-versus-host Disease||Drug: carfilzumib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of Carfilzomib -a Novel Proteasome Inhibitor- for the Prevention of Acute Graft Versus Host Disease|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
Carfilzomib at a dose of 20mg/m2 I.V. will be administrated at day 1, 2 post infusion of the stem cell (SC) graft to the first 10 patients. If no > grade II toxicity* the next 10 patients will receive Carfilzomib (27 mg/m2) at day 1,2 and 8, 9, 15 and 16. If no > grade II toxicity* the next 10 patients will receive 2-3 cycles of Carfilzomib (27 mg/m2) administered at day 1,2 8,9,15 and 16 post SC graft infusion.
carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease.
- incidence of acute graft-versus host disease [ Time Frame: 3 months ]We will evaluate the incidence of acute GVHD, grading and organ involvementBY STANDARD INTERNATIONAL CRITERIA.
- incidence of chronic graft-versus-host disease [ Time Frame: 1 year ]We will evaluate the progression of acute graft-versus-host disease to chronic graft-versus-host disease and the grading and organ involvement.
- survival rate [ Time Frame: 2 years ]We will evaluate overall and disease-free survival after stem cell transplantation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991301
|Contact: Arnon Nagler, MD||972 3 530 email@example.com|
|Contact: Avichai Shimoni, MD||972 3 530 firstname.lastname@example.org|
|Chaim Sheba Medical Center||Recruiting|
|Tel-Hashomer, Israel, 52621|
|Contact: Arnon Nagler, MD 972 3 530 5830 email@example.com|
|Contact: Avichai Shimoni, MD 972 3 530 5830 firstname.lastname@example.org|
|Principal Investigator: Arnon Nagler, MD|
|Principal Investigator:||Arnon Nagler, MD||Chaim Sheba Medical Center|