Diffuse Large B Cell Non-Hodgkin Lymphoma Clinical Trial
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)
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.
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.
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