This phase I trial studies the side effects and best dose of pevonedistat when given together
with ibrutinib in participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma that
has come back or has stopped responding to other treatments. Pevonedistat and ibrutinib may
stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
I. To evaluate the safety and tolerability of pevonedistat administered in combination with
ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and
non-Hodgkin lymphoma (NHL).
I. Overall response rate (ORR) will be determined based on the proportion of study
participants who achieve complete response (CR), complete response with incomplete marrow
recovery (CRi), partial response (PR) or nodular partial response (nPR) assessed after
completion of therapy.
II. Event-free survival (EFS), defined as the interval between the date of first study
treatment and the date of objective signs of disease recurrence, subsequent anti-leukemic
therapy, or death, whichever is first reported.
OUTLINE: This is a dose-escalation study of pevonedistat.
Participants receive pevonedistat intravenously (IV) over 1 hour on days 1, 3, and 5, and
ibrutinib orally (PO) daily on days 2-21 of course 1 and days 1-21 of subsequent courses.
Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity. Participants then receive only ibrutinib PO daily on days 1-21.
Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or
After completion of study treatment, participants will be followed up for every 3 months
Refractory Follicular Lymphoma, Recurrent Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Refractory Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia Refractory, Recurrent Non-Hodgkin Lymphoma, Refractory Lymphoplasmacytic Lymphoma, chronic lymphocytic leukemia, relapsed, Recurrent Lymphoplasmacytic Lymphoma, Refractory Small Lymphocytic Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Recurrent Marginal Zone Lymphoma, Richter's Transformation, Refractory Non Hodgkin Lymphoma, Richter Syndrome, Refractory Diffuse Large B Cell Lymphoma, B-cell prolymphocytic leukemia, Recurrent Mantle Cell Lymphoma, Richter's Syndrome, Refractory Mantle Cell Lymphoma
laboratory biomarker analysis,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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