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Clinical Trial 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.


Clinical Trial Description

PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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 unacceptable toxicity. After completion of study treatment, participants will be followed up for every 3 months ;


Study Design


Related Conditions & MeSH terms

  • B-Cell Prolymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic
  • Leukemia, Prolymphocytic, B-Cell
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Recurrence
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Lymphoplasmacytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Small Lymphocytic Lymphoma
  • Richter Syndrome
  • Waldenstrom Macroglobulinemia

NCT number NCT03479268
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 22, 2018
Completion date June 22, 2024

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