Extended Ibrutinib Treatment for Non-Hodgkin's Lymphoma

Recruiting at 108 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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial provides continued access to ibrutinib for patients who benefited from previous studies and cannot buy it locally. Ibrutinib is an oral medication that stops cancer cells from growing by blocking a protein they need. It is used in the treatment of chronic lymphocytic leukemia and has been studied for its effectiveness in relapsed CLL and as frontline therapy.

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 data supports the effectiveness of the drug Ibrutinib (Imbruvica) for treating Non-Hodgkin's Lymphoma?

Ibrutinib has shown effectiveness in treating certain types of Non-Hodgkin's Lymphoma, such as mantle cell lymphoma and chronic lymphocytic leukemia, by improving survival rates and response rates. It works by blocking signals that help cancer cells grow, and it has been approved for use in these conditions due to its positive results in clinical studies. ^{1 2 3 4 5}

Is ibrutinib safe for humans?

Ibrutinib, also known as Imbruvica, has been generally well-tolerated in clinical trials for various blood cancers, with less than 10% of patients stopping treatment due to side effects. However, some serious side effects like bleeding and heart rhythm problems have been reported, so these should be considered when evaluating its safety. ^{1 2 3 6 7}

How does the drug ibrutinib differ from other treatments for non-Hodgkin's lymphoma?

Ibrutinib is unique because it is an oral medication that specifically targets and inhibits Bruton's tyrosine kinase (BTK), a protein involved in the growth of B-cell cancers like non-Hodgkin's lymphoma. This targeted approach can lead to fewer side effects compared to traditional chemotherapy, and it offers a convenient once-daily dosing. ^{1 2 3 5 6}

Research Team

Kevin Wu

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia. [2021]

2. France pubmed.ncbi.nlm.nih.gov

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

3. New Zealand pubmed.ncbi.nlm.nih.gov

Ibrutinib: first global approval. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmaceutical approval update. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Imbruvica®▾(ibrutinib) patient support programme for chronic lymphocytic leukaemia and mantle cell lymphoma. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Spontaneous Iliopsoas Muscle Hemorrhage Secondary to Ibrutinib (Imbruvica; Pharmacyclics): Brief Report. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

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