Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02145403|
Recruitment Status : Active, not recruiting
First Posted : May 22, 2014
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies Relapse Graft-Versus-Host Disease||Drug: Carfilzomib Drug: Tacrolimus||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and Graft-versus-host Disease in Allogeneic Hematopoietic Cell Transplantation for High-risk Hematologic Malignancies|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Carfilzomib will be administered IV over 30 minutes, starting at dose level 1 (20 mg/m2 IV) on Day +1, +2, +6 and +7.
Carfilzomib will be administered starting at dose level 1 (20 mg/m2 IV) on day +1, +2, +6 and +7.
Dose escalation will be performed on the day +6 and day +7 doses only in each dose level. Day +1 and day+2 doses will be fixed at 20 mg/m2 IV in all dose levels.
Other Name: Kyprolis®
Tacrolimus will be administered at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
- The proportion of patients who are alive and have not developed any "event" [ Time Frame: 1 year ]The proportion of patients who are alive and have not developed relapse/progression of primary disease or clinical grade III-IV acute graft-versus-host disease (GVHD) or chronic GVHD requiring systemic treatment.
- Progression/ Relapse-free survival time [ Time Frame: Up to 3 years ]Time from day 0 to the date of the first Progression/ Relapse.
- Overall survival time [ Time Frame: Up to 3 years ]The time from day 0 to the day of death from any cause.
- Number of regimen related toxicities [ Time Frame: Up to 30 days post treatment ]The type and number of adverse events related to the study drug.
- Cumulative incidence of acute GVHD [ Time Frame: Up to 3 years ]The cumulative incidence of acute Graft Versus Host Disease (GVHD)
- Cumulative incidence of chronic GVHD [ Time Frame: Up to 3 years ]The cumulative incidence of chronic Graft Versus Host Disease (GVHD)
- Cumulative incidence of non-relapse mortality [ Time Frame: Up to 3 years ]The cumulative incidence of non-relapse mortality
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): NCT02145403
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Attaphol Pawarode, M.D.||University of Michgan Cancer Center|