Long-term Ibrutinib for Lymphoma

(CAN3001 Trial)

Recruiting at 84 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: Ibrutinib

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

Disqualifiers: Significant risk conditions, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Duration: Until disease progression or unacceptable toxicity

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather long-term safety and effectiveness data for ibrutinib, a treatment for lymphoma, and to continue providing it to individuals already benefiting from it. Ibrutinib has been used in some completed studies to treat lymphoma, and this trial targets those who have been on it for at least six months and still find it helpful. This trial suits those currently in an ibrutinib study who continue to receive and benefit from the treatment. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of ibrutinib for wider use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain blood thinners like warfarin or strong CYP3A4/5 inhibitors unless approved by the sponsor.

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

Research has shown that ibrutinib is generally well-tolerated by people with chronic lymphocytic leukemia (CLL) and other B-cell lymphomas. Studies have found that its side effects are usually manageable, with the most common being a low blood platelet count, diarrhea, and fatigue.

One study compared ibrutinib with a similar treatment and found that both had similar safety levels, indicating that ibrutinib is a relatively safe choice for many patients. While side effects can occur, most people can manage them.

These findings provide a clear picture of ibrutinib’s safety in humans, as it is already used to treat certain blood cancers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ibrutinib is unique because it targets a specific protein called Bruton's tyrosine kinase (BTK), which plays a key role in the growth and survival of lymphoma cells. Most treatments for lymphoma, like chemotherapy, attack rapidly dividing cells in a broader, less targeted way, often leading to more side effects. Researchers are excited about Ibrutinib because it offers a more precise approach, potentially reducing side effects while effectively controlling the disease. This targeted action provides hope for improved outcomes in patients with lymphoma, especially those who may not respond well to traditional therapies.

What is the effectiveness track record for ibrutinib in treating lymphoma?

Research has shown that ibrutinib, the treatment under study in this trial, effectively treats certain types of lymphoma. Studies have found that it benefits 71% to 90% of patients. Among those taking ibrutinib, about 89% to 93% do not experience disease progression within a year. Real-world evidence also supports its benefits, with survival rates around 89% for some patients. These findings suggest that ibrutinib can be a promising option for people with lymphoma. ^{1 3 5 6 7}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for patients already enrolled in completed ibrutinib studies, having received at least 6 months of treatment. They should benefit from continued use and agree to contraception. Excluded are those needing strong CYP3A4/5 inhibitors or anticoagulants like warfarin.

Inclusion Criteria

My doctor believes the benefits of my current cancer treatment outweigh the risks.

I am currently being treated with ibrutinib alone or with nivolumab, or I am in a specific ibrutinib study.

I have been in an ibrutinib study for over 6 months.

Exclusion Criteria

I need blood thinners like warfarin.

I need treatment with specific strong medications, approved by the trial sponsor.

Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue with the current ibrutinib dosing regimen established in the parent ibrutinib study

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants receive long-term access to ibrutinib until alternative access is available or the study ends

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Ibrutinib

Trial Overview The study aims to collect long-term data on the safety and effectiveness of the drug Ibrutinib for various lymphomas, leukemias, and graft-versus-host disease. It provides ongoing access to Ibrutinib for eligible participants.

How Is the Trial Designed?

Group I: Ibrutinib Experimental Treatment 1 Intervention

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in United States as Imbruvica for:

• Chronic lymphocytic leukemia/small lymphocytic lymphoma
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma
• Graft-versus-host disease

Approved in Canada as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia
• Marginal zone lymphoma

Approved in Japan as Imbruvica for:

• Chronic lymphocytic leukemia
• Mantle cell lymphoma
• Waldenström's macroglobulinemia

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

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

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Pharmacyclics LLC.

Industry Sponsor

Trials

114

Recruited

13,800+

Dr. Maky Zanganeh

Pharmacyclics LLC.

Chief Executive Officer

Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France

Dr. Ellie Im

Pharmacyclics LLC.

Chief Medical Officer

MD from an unspecified institution

Published Research Related to This Trial

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 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 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]

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 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 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, a Bruton's kinase inhibitor, has shown a high overall response rate of 68% in patients with relapsed or refractory mantle cell lymphoma, with a median progression-free survival of 13.9 months, indicating its efficacy as a treatment option.

In a phase 3 trial for chronic lymphocytic leukemia, ibrutinib demonstrated a significantly higher response rate (43% vs. 4% for ofatumumab) and improved overall survival (90% vs. 81% at 12 months), while being well tolerated with no dose-limiting toxicity, making it a suitable option for older patients and those not eligible for intensive chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of a novel, Bruton's tyrosine kinase inhibitor, ibrutinib. Lee, CS., Rattu, MA., Kim, SS.[2021]

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. 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, ...