CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Carfilzomib +1 moredrug
Likely dose
Carfilzomib 20 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02145403
NCT02145403Phase 2Completed
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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

University of Michigan Rogel Cancer Center·interventional·Posted May 22, 2014·Updated Jan 3, 2022

In Brief

A Phase 2 clinical trial evaluating Carfilzomib and Tacrolimus for Hematologic Malignancies and 2 related conditions. Completed, enrolled 53 participants across 1 site.

Detailed Summary

The investigators hypothesize that adding carfilzomib to standard conditioning regimen for allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant relapse and treatment-related mortality by decreasing severe GVHD, leading to overall improvement in transplant outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancies, Relapse, Graft-Versus-Host Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 22, 2014
Enrollment StartOct 1, 2014
Primary CompletionNov 26, 2018
Study CompletionOct 16, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.1 years ago

Interventions

Carfilzomibdrug

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.

Tacrolimusdrug

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.