Extended Ibrutinib Treatment for Non-Hodgkin's Lymphoma

Not currently recruiting at 128 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Pharmacyclics Switzerland GmbH

Must be taking: Ibrutinib

Disqualifiers: Pregnancy, Breastfeeding, Cognitive impairment, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the extended use of ibrutinib for individuals with Non-Hodgkin's Lymphoma who participated in a previous study using this medication. Ibrutinib may help control the disease. The trial aims to determine if continued treatment with ibrutinib benefits those unable to access it in their region. It suits individuals who completed a prior ibrutinib study and wish to continue using the medication to manage their condition. As a Phase 4 trial, this study seeks to understand how this FDA-approved and effective treatment can benefit more patients.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on continuing ibrutinib treatment, so it's best to discuss your specific medications with the trial team.

What is the safety track record for this treatment?

Research shows that ibrutinib, the treatment under study, is generally well-tolerated by patients. The FDA has already approved it for treating certain types of non-Hodgkin's lymphoma, indicating it has passed safety checks for those conditions.

In a previous study, diarrhea was the most common side effect, affecting about 38% of patients. Another study found that increased bilirubin levels in the blood were a rare side effect. Overall, the safety profile remains consistent, with people usually experiencing the same kinds of side effects.

As a Phase 4 trial, this study focuses on long-term safety and effectiveness. The treatment is already considered safe from earlier studies, but researchers are now examining its long-term performance. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Ibrutinib for treating Non-Hodgkin's Lymphoma because it targets a specific protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the growth and survival of cancer cells. Unlike traditional chemotherapy that affects both healthy and cancerous cells, Ibrutinib's targeted approach potentially results in fewer side effects and better tolerability. Additionally, Ibrutinib is taken orally as a pill, offering a more convenient option compared to some treatments that require intravenous administration. This makes it a promising alternative for patients seeking effective and manageable treatment options.

What is the effectiveness track record for ibrutinib in treating Non-Hodgkin's Lymphoma?

Research has shown that ibrutinib, the treatment under study in this trial, effectively treats non-Hodgkin's lymphoma. One study reported that 85% of patients responded positively, with 35% achieving a complete response, meaning all signs of cancer disappeared. Another study found a 69% response rate, with some patients experiencing full or partial remission, indicating a reduction in cancer symptoms. These results suggest that ibrutinib can significantly help manage the disease. Patients in this trial should continue taking ibrutinib, as stopping it may lead to worse outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Kevin Wu

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for patients already in an ibrutinib study who've seen benefits but can't get the drug commercially. They must have finished all previous study requirements, agree to birth control methods, and not be pregnant or planning pregnancy.

Inclusion Criteria

Subject must have participated in an eligible ibrutinib clinical trial and may derive clinical benefit from continued treatment or restart of treatment with ibrutinib in the opinion of the treating physician

I am currently on continuous treatment with ibrutinib.

I have finished all tests in my current treatment plan and wish to keep taking ibrutinib.

Exclusion Criteria

I am willing and able to follow all study requirements.

Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol

I plan to try for a child during or within 3 months after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Extended Treatment

Participants receive continuous oral dosing with ibrutinib at the same dose and schedule as in the parent study

Up to 3 years

Visits per local standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ibrutinib

Trial Overview The trial provides ongoing access to ibrutinib for those benefiting from it after completing prior studies. It's open-label and multicenter, meaning both doctors and participants know they're getting ibrutinib, at various locations.

How Is the Trial Designed?

Group I: Ibrutinib Experimental Treatment 1 Intervention

Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Pharmacyclics Switzerland GmbH

Lead Sponsor

Trials

2

Recruited

670+

Janssen Biotech, Inc., including Johnson & Johnson

Collaborator

Trials

1

Recruited

600+

Published Research Related to This Trial

Ibrutinib is an effective treatment for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), showing better outcomes than traditional therapies like chlorambucil and ofatumumab in phase III trials involving elderly and previously-treated patients.

The drug has a good safety profile, although it can cause some adverse effects like bleeding and atrial fibrillation; it is recommended in treatment guidelines for patients with high-risk disease, including those with specific genetic mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib: A Review in Chronic Lymphocytic Leukaemia. Deeks, ED.[2021]

Ibrutinib is the first FDA-approved drug that inhibits Burton's tyrosine kinase (BTK), effectively reducing B-cell proliferation and promoting apoptosis, making it a significant treatment for relapsed chronic lymphocytic leukemia and Waldenström's macroglobulinemia.

Despite its efficacy, ibrutinib can lead to serious side effects, including rare but severe hemorrhagic events, as demonstrated by a case of back pain caused by iliopsoas muscle hemorrhage in a patient after starting the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous Iliopsoas Muscle Hemorrhage Secondary to Ibrutinib (Imbruvica; Pharmacyclics): Brief Report. Sarcon, A., Botta, GP., Patel, N., et al.[2018]

Ibrutinib (Imbruvica) is an effective treatment for chronic lymphocytic leukemia, targeting specific pathways to inhibit cancer cell growth.

Tasimelteon (Hetlioz) is beneficial for individuals with non-24-hour sleep-wake disorder, helping to regulate sleep patterns, while anti-inhibitor coagulant complex (Feiba) is used to prevent or reduce bleeding episodes in patients with hemophilia A or B, demonstrating its efficacy in managing bleeding risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmaceutical approval update. Goldenberg, MM.[2021]

Ibrutinib is a targeted therapy specifically designed for treating chronic lymphocytic leukemia (CLL), which is a type of cancer that affects the blood and bone marrow.

This novel treatment works by inhibiting Bruton's tyrosine kinase (BTK), a key enzyme that helps cancer cells survive and proliferate, leading to improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia. Parmar, S., Patel, K., Pinilla-Ibarz, J.[2021]

Ibrutinib is an effective oral treatment for patients with relapsed/refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukaemia (CLL), showing a 68% overall response rate in MCL and significant improvements in progression-free survival and overall survival in CLL patients, including those with specific genetic mutations.

The drug has a good safety profile, with less than 10% of patients discontinuing treatment due to adverse effects, making it a promising option for patients with various B-cell malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ibrutinib: A new drug of B-cell malignancies]. Thieblemont, C.[2021]

Ibrutinib is a first-in-class oral Bruton's tyrosine kinase inhibitor that effectively blocks B-cell signaling, leading to reduced proliferation and increased cell death in B cell malignancies, including chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL).

It has received FDA approval for treating MCL in previously treated patients based on phase Ib/II study results and is currently undergoing further phase III trials for CLL, diffuse large B cell lymphoma (DLBCL), and other B cell cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib: first global approval. Cameron, F., Sanford, M.[2022]

Ibrutinib is an effective oral therapy for chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma, mantle cell lymphoma, and Waldenstrom's macroglobulinaemia, providing a significant alternative to traditional chemotherapy.

The You&i™ support program enhances patient experience by connecting them with nurses for guidance on treatment and side effects, demonstrating positive feedback from both patients and health professionals in a tested NHS hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imbruvica®▾(ibrutinib) patient support programme for chronic lymphocytic leukaemia and mantle cell lymphoma. Murthy, V., Weaving, S., Paneesha, S.[2021]

Citations

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Phase 2 trial of ibrutinib and nivolumab in patients with ... Ibrutinib and nivolumab showed a response rate of 78% and the best complete response rate was 50% for relapsed/refractory CNS lymphomas.

2. bloodresearch.or.kr bloodresearch.or.kr/journal/view.html?uid=2650&vmd=Full

A retrospective analysis of ibrutinib outcomes in relapsed ... During a median follow-up of 46.0 months, the response rate to ibrutinib was 69%, with 12 CRs and 8 partial responses. Disease progression (54.8 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6339827/

Ibrutinib Dose Adherence and Therapeutic Efficacy in Non- ... In this observational study, NHL and CLL patients demonstrated poor outcomes after discontinuing ibrutinib for disease progression.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265018306396

Ibrutinib Dose Adherence and Therapeutic Efficacy in Non- ... Conclusion. In this observational study, non-Hodgkin lymphoma and CLL patients experienced poor outcomes after discontinuing ibrutinib for disease progression.

5. news.abbvie.com news.abbvie.com/2016-12-04-Favorable-Response-Rates-Suggest-Promise-of-Ibrutinib-IMBRUVICA-Combination-Therapy-in-Two-Common-Types-of-Non-Hodgkins-Lymphoma

Favorable Response Rates Suggest Promise of Ibrutinib ... At a median time on study of 22 months, the overall response rate (ORR) was 85%, with 35% of patients achieving a complete response (CR).2 The ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1040842824003408

Efficacy and safety of ibrutinib in central nervous system ... Our analysis investigated the effect of Ibrutinib on the overall response rate in patients with central nervous system lymphoma, using data from 13 studies. The ...

7. news.abbvie.com news.abbvie.com/2017-01-19-U-S-FDA-Approves-IMBRUVICA-ibrutinib-as-First-Treatment-Specifically-Indicated-for-Relapsed-Refractory-Marginal-Zone-Lymphoma-MZL-a-Rare-Type-of-Non-Hodgkins-Lymphoma

U.S. FDA Approves IMBRUVICA® (ibrutinib) as First ... IMBRUVICA is now approved to treat patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.

8. innovativemedicine.jnj.com innovativemedicine.jnj.com/emea/newsroom/european-commission-approves-imbruvica-ibrutinib-as-the-first-targeted-therapy-for-patients-with-previously-untreated-mantle-cell-lymphoma-who-would-be-eligible-for-autologous-stem-cell-transplant

European Commission approves IMBRUVICA® (ibrutinib) ... The overall safety profile of the ibrutinib + CIT regimen was consistent with the previously known safety profile of ibrutinib.3 The most common ...

9. thelancet.com thelancet.com/journals/lanhae/article/PIIS2352-3026(18)30217-5/abstract

Safety and activity of ibrutinib in combination with ... One dose-limiting toxicity (grade 3 hyperbilirubinaemia) was reported at the 420 mg dose in the diffuse large B-cell lymphoma cohort, which ...

10. 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 ... The most common adverse event was diarrhea: 8 (38.1%) patients. The ORR was 66.6% (20.0% CR and 46.6% PR) in the final response assessment during the treatment.