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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

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 3

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jennifer WoyachLead Sponsor

3 Previous Clinical Trials

67 Total Patients Enrolled

Karyopharm Therapeutics IncIndustry Sponsor

87 Previous Clinical Trials

7,545 Total Patients Enrolled

Jennifer Woyach, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

4 Previous Clinical Trials

119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards could be associated with participating in a Pharmacological Study?

"Our experts at Power believe that the safety of this pharmacological study ranks as a 1, due to it being in its preliminary phases with only minimal evidence of efficacy and security."

Answered by AI

What is the current number of participants in this research study?

"This research initiative is no longer open for patient recruitment, having been initially posted on March 11th 2015 and last updated April 29th 2022. However, if you are searching for other medical studies to participate in, there are 3744 trials with diffuse lymphoma looking for participants and 201 pharmacological clinical trials currently enlisting patients."

Answered by AI

Is the research team in search of participants to join their study?

"Unfortunately, this study is no longer taking on new participants. Initially posted in March of 2015 and last updated April 29th 2022, it has been closed for recruitment. However, there are currently 3,744 studies accepting patients with lymphoma diffuse and 201 trials recruiting for pharmacological research."

Answered by AI

Has there been past research on Pharmacological Study?

"In 2011, the National Institutes of Health Clinical Center initiated a Pharmacological Study at 9000 Rockville Pike. To date, 715 trials have been finished and 201 are currently active across numerous locations in Salt Lake City, Utah."

Answered by AI

How does Pharmacological Study usually serve as a helpful treatment?

"Mantle cell lymphoma (MCL) is often treated with Pharmacological Study, a medication that can also help patients manage Waldenstrom Macroglobulinemia, Chronic lymphocytic leukemia (CLL), and other therapeutic procedures."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Selinexor Combined with Ibrutinib Demonstrates Tolerability and Safety in Advanced B-cell Malignancies: A Phase I Study

Stephens, Deborah M., Ying Huang, Amy S. Ruppert, Janek S. Walker, Daniel Canfield, Casey B. Cempre, Qiang Fu, et al.. 2022. “Selinexor Combined with Ibrutinib Demonstrates Tolerability and Safety in Advanced B-cell Malignancies: A Phase I Study”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-21-3867.

Clinical Cancer ResearchJournal

Selinexor Combined with Ibrutinib Demonstrates Tolerability and Safety in Advanced B-cell Malignancies: A Phase I Study

clinicaltrials.govStudy

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

Jennifer Woyach 2015. "Selinexor and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Aggressive Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02303392.

All > Cll > Chronic Lymphocytic Leukemia