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Bruton's Tyrosine Kinase Inhibitor

Ibrutinib for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Erlene Seymour, M.D.

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with relapsed or refractory classical HL who have previously received autologous stem cell transplant and/or allogeneic stem cell transplant

Patients must have received prior autologous stem cell transplant at least 12 weeks (3 months) before the first dose of ibrutinib and/or allogeneic stem cell transplant must have been completed at least 6 months prior to the first dose of Ibrutinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of study entry until completion of testing up to 24 months

Awards & highlights

Study Summary

This trial is testing how effective ibrutinib is in treating classical Hodgkin lymphoma that has come back or didn't respond to initial treatment. Ibrutinib may stop cancer cell growth by blocking enzymes needed for cell growth, or by affecting the tumor's environment or the immune system.

Who is the study for?

Adults with classical Hodgkin lymphoma that has come back or didn't respond to treatment, including those who've had stem cell transplants. Participants need good blood counts without transfusions for a week, no recent other cancer treatments, and must use effective birth control. Excluded are those with certain prior conditions like brain disease, recent heart issues, active infections or immune deficiencies.Check my eligibility

What is being tested?

The trial is testing the effectiveness of a daily oral dose of Ibrutinib (560 mg) in patients with relapsed or refractory classical Hodgkin lymphoma. It explores how Ibrutinib might inhibit cancer growth by blocking enzymes needed for cell growth and modifying the tumor environment.See study design

What are the potential side effects?

Ibrutinib may cause side effects such as bleeding problems, high blood pressure, irregular heartbeat, new cancers, infections due to low white blood cells count; diarrhea; muscle and bone pain; rash; nausea; bruising; tiredness and fever.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have classical Hodgkin lymphoma and have had a stem cell transplant.

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I had a stem cell transplant more than 3 months ago for autologous or more than 6 months ago for allogeneic before starting Ibrutinib.

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My Hodgkin lymphoma has not improved after 2 treatments and I can't have a stem cell transplant.

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I am not able to have children or I have a negative pregnancy test if I can.

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I am able to care for myself and perform daily activities.

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I have had at least 2 treatments for Hodgkin lymphoma, including brentuximab vedotin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of study entry until completion of testing up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of study entry until completion of testing up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of study entry until completion of testing up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate (ORR) defined as the proportion of participants having a complete (CR) and partial (PR) response

Secondary outcome measures

Duration of response (DOR)

Incidence of Treatment-Emergent adverse Events (safety and tolerability)

Progression free survival (PFS)

Other outcome measures

Identify which genes and immune alterations are affected by ibrutinib.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib)Experimental Treatment3 Interventions

Patients receive ibrutinib PO QD. 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

Ibrutinib

2014

Completed Phase 3

~1880

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Barbara Ann Karmanos Cancer InstituteLead Sponsor

163 Previous Clinical Trials

9,251 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,632 Total Patients Enrolled

Erlene Seymour, M.D.Principal InvestigatorBarbara Ann Karmanos Cancer Institute

Frequently Asked Questions

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

What has been the aggregate participation rate of this clinical trial?

"As of June 24th, 2022 this clinical trial is now closed for enrollment. The study was initially posted on the first day of June 2016 and has since stopped participant recruitment. For those still looking to get involved in a medical trial, there are currently 1725 studies targeting lymphoma patients and 155 Pharmacological Study trials actively searching for participants."

Answered by AI

Are there any preceding examinations with Pharmacological Study?

"The initial research for the Pharmacological Study was conducted in 2011 at National Institutes of Health Clinical Center, 9000 Rockville Pike. To date, 687 trials have been completed and 155 experiments are ongoing. Of these active studies many originate from Detroit, Michigan."

Answered by AI

Has the Pharmacological Study been ratified by any governmental regulatory agencies?

"Since it is a Phase 2 study, with limited data backing the drug's safety and none for efficacy, our team has rated this pharmacological trial as a score of 2."

Answered by AI

Is the enrollment phase of this clinical trial currently open?

"This study, which was initially posted in June 2016 and last updated on the 24th of June 2022, is not seeking participants at this time. Nevertheless, there are 1880 other clinical trials actively looking for patient enrolment as we speak."

Answered by AI

Recent research and studies

HeliyonJournal

Pre-clinical Anti-tumor Activity of Bruton's Tyrosine Kinase Inhibitor in Hodgkin's Lymphoma Cellular and Subcutaneous Tumor Model

Muqbil, Irfana, Mahmoud Chaker, Amro Aboukameel, Ramzi M. Mohammad, Asfar S. Azmi, and Radhakrishanan Ramchandren. 2019. “Pre-clinical Anti-tumor Activity of Bruton's Tyrosine Kinase Inhibitor in Hodgkin's Lymphoma Cellular and Subcutaneous Tumor Model”. Heliyon. Elsevier BV. doi:10.1016/j.heliyon.2019.e02290.

clinicaltrials.govStudy

Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Dipenkumar Modi 2016. "Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02824029.