Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Jennifer Woyach
Study ID
NCT02303392
Phase
PHASE1
Status
Completed

Conditions

  • Prolymphocytic Leukemia
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Given PO
  • Ibrutinib — DRUG
    Given PO
  • Pharmacological Study — OTHER
    Correlative studies
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of selinexor when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving selinexor together with ibrutinib may be a better treatment for chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma.

Key Dates

Start date
Jun 9, 2015
Status verified
May 2025
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (selinexor, ibrutinib)
    Patients receive ibrutinib PO on days 8-28 of course 1 and on days 1-28 on subsequent courses and selinexor PO BID weekly on day 1 or bi-weekly on days 1 and 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose for Selinexor [ Time Frame: Day 28 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbusOhio43210-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Columbus, OH

By research site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center· Columbus, OHHuntsman Cancer Institute· Salt Lake City, UT

Related Studies