Carfilzomib for the Prevention of Graft Versus Host Disease
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|