ADAM17 Inhibitor/ Rituximab After Auto HCT for DLBCL
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|ClinicalTrials.gov Identifier: NCT02141451|
Recruitment Status : Active, not recruiting
First Posted : May 19, 2014
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Non-Hodgkin Lymphoma||Drug: Rituximab Drug: INCB7839||Phase 1 Phase 2|
The primary goal of the dose finding phase is to determine the maximum tolerated dose (MTD) of INCB7839. Up to three dose levels will be tested (100 mg bid, 200 mg bid, and 300 mg bid). As the 300 mg bid has been proven safe in the non-transplant setting, dose escalation follows a Fast-Track Design with 1 patient enrolled per dose level unless a grade 2 or greater treatment emergent event occurs within the 1st 14 days of INCB7839. At that point, dose escalation converts to a standard 3+3 design and two additional patients are enrolled at the current dose level. If dose level 3 is completed without dose limiting toxicity (DLT) in the 1st 3 patients, an additional 3 patients will be enrolled at this level (without the staggering required by the DLT rules) prior to moving to the phase II component.
Once the phase I dose escalation is completed, an additional 12 patients will be enrolled at the MTD (or dose level 3, if no DLT) to obtain a more detailed toxicity profile as well as a preliminary estimate of progression free survival at 6 months post-transplant.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||January 23, 2019|
|Estimated Study Completion Date :||May 2020|
Rituximab will be given after day +28 re-staging and again 1 and 7 weeks later, followed by INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab
Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later
Other Name: Rituxan
INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab
- Maximum Tolerated Dose of INCB7839 [ Time Frame: 2 weeks ]The Phase I design will continue until the MTD is declared or until the first dose is declared to be above MTD. Phase I dose limiting toxicity (DLT) is defined as Grade 3-5 non-hematologic, non-infectious toxicity including thromboembolic complications and select hematologic events including: grade 4 neutropenia lasting for ≥ 7 days, febrile neutropenia, grade 4 thrombocytopenia lasting ≥ 7 days despite dose delay or grade 3 thrombocytopenia associated with bleeding.
- Rate of progression free survival [ Time Frame: 6 months ]This Phase 2 primary end point will be estimated with Kaplan-Meier curves.
- Incidence of Serious Adverse Events [ Time Frame: 1 year ]To determine incidence of serious adverse events
- Rate of disease free survival [ Time Frame: 1 year ]To evaluate 1 year disease-free survival
- Rate of overall survival [ Time Frame: 1 year ]To evaluate 1 year overall survival
- Mean time to progression [ Time Frame: 1 year ]To determine mean time to relapse/progression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141451
|United States, Minnesota|
|University of Minnesota Medical Center, Fairview|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Veronika Bachanova, MD||University of Minnesota Medical Center, Fairview|