Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgki… (NCT03479268) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pevonedistat and Ibrutinib in Treating Participants With Relapsed or Refractory CLL or Non-Hodgkin Lymphoma
United States18 participantsStarted 2018-04-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Dose escalation cohort:
* Histologically or flow cytometry confirmed diagnosis of B-CLL/small lymphocytic lymphoma (SLL) according to National Cancer Institute sponsored Working Group (NCI-WG) 1996 guidelines
* The following types of NHL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO):
* Mantle cell lymphoma (MCL)
* Follicular lymphoma (FL) - grades 1-3a
* Lymphoplasmacytic lymphoma (LPL)
* Marginal zone lymphoma (MZL)
* CLL in Richter's transformation
* B-cell prolymphocytic leukemia (B-PLL)
* Diffuse large B-cell lymphoma (DLBCL)
* Expansion cohort - histologically or flow cytometry confirmed diagnosis of B-CLL/SLL according to NCI-WG 1996 guidelines; patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma
* Patients with MCL underwent \>= 1 chemoimmunotherapy-based regimen; patients with FL and MZL underwent \>= 1 prior chemotherapy-based and/or immunotherapy-based regimen; patients with DLBCL and CLL in Richter's transformation underwent \>= 1 chemoimmunotherapy-based regimen and are not transplant-eligible; patients with CLL, B-PLL and LPL underwent \>= 1 chemotherapy-based, or immunotherapy-based or targeted therapy regimen (e.g., PI3K inhibitors \[idelalisib\], venetoclax, ibrutinib or an investigational agent, inclu…
What they're measuring
1
Incidence of dose limiting toxicities (DLTs)
Timeframe: Up to 42 days
2
Incidence of adverse events (AEs), serious AEs (SAEs), dose interruptions, reductions and dose intensity Common Terminology Criteria for Adverse Events version 4.03
Timeframe: Up to 30 days after last course of treatment