Ibrutinib for Lymphoma

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: Warfarin, Strong CYP3A4/5 inhibitors

Disqualifiers: CNS involvement, Stroke, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called ibrutinib (Imbruvica) as a maintenance therapy for individuals with mantle cell lymphoma (MCL) who have responded well to chemotherapy. Ibrutinib blocks an enzyme that influences the growth and survival of certain white blood cells. The trial aims to determine if ibrutinib is safe and effective in preventing cancer recurrence. Individuals diagnosed with MCL who have completed specific chemotherapy treatments without disease progression might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on strong CYP3A4/5 inhibitors or require warfarin. If you're on a strong CYP3A4/5 inhibitor, you might be eligible if you can switch to a different medication before joining the study.

Is there any evidence suggesting that ibrutinib is likely to be safe for humans?

Research shows that ibrutinib is generally well-tolerated by patients with various B-cell lymphomas, such as chronic lymphocytic leukemia (CLL). Studies indicate it has a manageable side effect profile, meaning that while some side effects can occur, most are not severe.

A safety review found serious side effects in 5% or more of patients, but these are less common. Real-world studies also confirm that ibrutinib is effective and has a safety profile similar to other treatments.

Overall, while some patients may experience side effects, ibrutinib is considered a safe option for treating certain lymphomas. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lymphoma?

Ibrutinib is unique because it targets a specific protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the survival and spread of cancer cells in lymphoma. Unlike the standard chemotherapy treatments, which can affect both healthy and cancerous cells, ibrutinib is more selective, potentially leading to fewer side effects. Researchers are excited about ibrutinib because it offers a targeted approach that could improve outcomes for patients with lymphoma by directly interfering with the cancer cell's survival pathways.

What evidence suggests that ibrutinib might be an effective treatment for mantle cell lymphoma?

Research has shown that ibrutinib, which participants in this trial will receive, may effectively treat mantle cell lymphoma (MCL). In several studies, 89% to 93% of patients did not experience disease progression within a year, known as the 12-month progression-free survival rate. The overall response rate, measuring how well tumors shrink or disappear with treatment, ranged from 71% to 90%. Although some real-world studies have noted challenges with side effects, ibrutinib has effectively controlled the disease for many patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Barbara Pro, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for patients with mantle cell lymphoma who've responded to induction chemotherapy. They must have finished chemo at least 14 days ago but no more than 90 days prior, or show engraftment post-auto stem cell transplant. Participants need an ECOG performance status of <=2, indicating they can perform daily activities with some limitations.

Inclusion Criteria

I meet the timing requirements for chemotherapy and stem cell transplant.

I may or may not have measurable cancer, but if I do, it will be monitored.

I have had radiotherapy before.

Exclusion Criteria

My lymphoma has spread to my brain or spinal cord.

I have received specific treatments before.

Patients receiving ongoing treatment with investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy to which they must respond before starting ibrutinib maintenance

Varies

Ibrutinib Maintenance

Participants receive ibrutinib orally once daily on days 1-28, with courses repeating every 28 days for up to 4 years

Up to 4 years

Monthly visits for the first 6 months, then every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 4 years post-first dose

Every 3 months for 2 years, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ibrutinib

Trial Overview The study tests if the drug Ibrutinib is effective as a maintenance therapy after initial chemo in MCL patients. It involves taking Ibrutinib and monitoring its effects on the disease through lab biomarker analysis to see how well it helps control cancer growth.

How Is the Trial Designed?

Group I: Treatment (ibrutinib) Experimental Treatment 2 Interventions

Patients receive ibrutinib orally PO QD on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity, or patient preference.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36534239/

Systematic Literature Review of Real-World Effectiveness ... Twelve-month progression-free survival rates ranged from 89% to 93%, and the overall response rate ranged from 71% to 90% across four studies.

2. ashpublications.org ashpublications.org/bloodadvances/article/9/15/3801/537228/Real-world-survival-outcomes-in-first-line

Real-world survival outcomes in first-line ibrutinib-treated ... Real-world studies have also confirmed the benefit of 1L ibrutinib treatment; specifically, real-world OS (rwOS) rates were reported to be 89% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2950328025000639

Real-world outcomes with ibrutinib in relapsed or refractory ... Real-world outcomes after initiation of ibrutinib for R/R MCL were poorer than observed in clinical trials, and dose limiting toxicities were common.

4. imbruvicahcp.com imbruvicahcp.com/cll

CLL and SLL Treatment | IMBRUVICA® (ibrutinib) HCP The median time to first dose reduction was 23.7 months, with a range of 1.6 to 78.4 months. Be aware that outcomes in a subgroup of patients with and without ...

5. news.abbvie.com news.abbvie.com/2017-06-05-Long-Term-IMBRUVICA-R-ibrutinib-Efficacy-and-Safety-Data-at-ASCO-2017-Show-Sustained-Survival-Rates-in-Up-to-Four-Years-in-Previously-Treated-Chronic-Lymphocytic-Leukemia-Small-Lymphocytic-Lymphoma-CLL-SLL-Patients-Including-Those-with-High-Ris

Long-Term IMBRUVICA® (ibrutinib) Efficacy and Safety ... Data show 59 percent progression free survival and 74 percent overall survival in CLL/SLL patients treated with IMBRUVICA, with high-risk patients trending to ...

6. bloodresearch.or.kr bloodresearch.or.kr/journal/view.html?doi=10.5045/br.2020.2020158

Safety and efficacy analysis of ibrutinib in 32 patients with ... Ibrutinib is a good treatment option for CLL and other B-cell lymphomas; it has an acceptable side effect profile with high and promising CR/PR rates.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9492818/

Real-World Effectiveness and Safety of Ibrutinib in Clinical ... The FIRE study investigated the real-world effectiveness and safety of ibrutinib in prospectively observed patients with chronic lymphocytic leukemia (CLL)

8. sciencedirect.com sciencedirect.com/science/article/pii/S2950328024000645

Real-world safety profile of therapy with ibrutinib or ... The ELEVATE-RR trial compared treatment with ibrutinib vs acalabrutinib in previously treated CLL, showing similar progression-free survival with both agents, ...