CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Rituximab +1 moredrug
Likely dose
Rituximab 375 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/NCT02141451
NCT02141451Phase 2Completed
CompareCT.gov

Study of the ADAM17 Inhibitor INCB7839 Combined With Rituximab After Autologous Hematopoietic Cell Transplantation (HCT) For Patients With Diffuse Large B Cell Non-Hodgkin Lymphoma (DLBCL)

Masonic Cancer Center, University of Minnesota·interventional·Posted May 19, 2014·Updated Feb 19, 2020

In Brief

A Phase 2 clinical trial evaluating Rituximab and INCB7839 for Diffuse Large B Cell Non-Hodgkin Lymphoma. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This is a single institution phase I/II study using an ADAM17 inhibitor (INCB7839) with rituximab as consolidation therapy after an autologous hematopoietic cell transplant (HCT) for patients with diffuse large B cell lymphoma (DLBCL). The study consists of two phases. The dose finding phase is a modified version of a phase I trial and the extended phase is a modified version of a phase II trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B Cell Non-Hodgkin Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 19, 2014
Enrollment StartMay 1, 2014
Primary CompletionJan 23, 2019
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.1 years ago

Interventions

Rituximabdrug

Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later

INCB7839drug

INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab