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Tyrosine Kinase Inhibitor

Pharmacological Study for Prolymphocytic Leukemia

Phase 1
Waitlist Available
Led By Jennifer Woyach, MD
Research Sponsored by Jennifer Woyach
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of selinexor when given with ibrutinib for patients with chronic lymphocytic leukemia or aggressive non-Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment.

Eligible Conditions
  • Prolymphocytic Leukemia
  • Mantle Cell Lymphoma
  • Lymphoma
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4 criteria
Secondary outcome measures
Clinical response defined as those with CR or PR measured by International Working Group Criteria for NHL patients and IWCLL 2008 guidelines for CLL patients
Incident of toxicity graded by CTCAE V4
Overall Survival (OS)
+4 more
Other outcome measures
Change in localization of tumor suppressor and oncogene proteins and messenger ribonucleic acids (mRNAs)
Changes in markers of down modulation or inhibition of the B-cell receptor pathway
Pharmacokinetic parameters

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (selinexor, ibrutinib)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Ibrutinib
2014
Completed Phase 4
~1890

Find a Location

Who is running the clinical trial?

Jennifer WoyachLead Sponsor
3 Previous Clinical Trials
67 Total Patients Enrolled
Karyopharm Therapeutics IncIndustry Sponsor
88 Previous Clinical Trials
7,605 Total Patients Enrolled
Jennifer Woyach, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
4 Previous Clinical Trials
119 Total Patients Enrolled
~3 spots leftby Jun 2025
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