Long-term Ibrutinib for Lymphoma
(CAN3001 Trial)
Recruiting in Palo Alto (17 mi)
+80 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
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
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial aims to provide ongoing access to ibrutinib for patients who have benefited from it in previous studies. Ibrutinib is an oral medication that blocks a protein involved in cancer growth, helping to slow or stop the disease. The study will monitor safety and effectiveness over time. Ibrutinib has been studied extensively and is used to treat various B cell malignancies, including chronic lymphocytic leukemia and mantle cell lymphoma.
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.
What evidence supports the effectiveness of the drug Ibrutinib (Imbruvica) for treating lymphoma?
Ibrutinib has shown to be effective in treating certain types of lymphoma, such as mantle cell lymphoma and chronic lymphocytic leukemia, with studies reporting high response rates and improved survival. It works by blocking signals that help cancer cells grow, and it is generally well-tolerated by patients.
12345Is ibrutinib safe for long-term use in humans?
Ibrutinib (Imbruvica) is generally considered safe for treating certain blood cancers, but some patients may experience side effects like bleeding and irregular heartbeats. In clinical trials, less than 10% of patients stopped using it due to side effects, though rare serious bleeding events have been reported.
12467What makes the drug Ibrutinib unique for treating lymphoma?
Ibrutinib is unique because it is an oral medication that specifically targets Bruton's tyrosine kinase, a key player in B-cell receptor signaling, which helps stop the growth of cancerous B cells. It is particularly effective for patients with certain genetic mutations and has shown impressive response rates and survival benefits in clinical trials, making it a promising option for those with relapsed or refractory lymphoma.
12346Eligibility Criteria
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.
+2 more
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
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: IbrutinibExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Avera Medical GroupSioux Falls, SD
Willamette Valley Cancer CenterEugene, OR
The Ohio State University- James Cancer HospitalColumbus, OH
St. Joseph Hospital Center for Cancer Prevention and TreatmentOrange, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLCLead Sponsor
Pharmacyclics LLC.Industry Sponsor
References
[Ibrutinib: A new drug of B-cell malignancies]. [2021]Ibrutinib (Imbruvica®) is a first-in-class, orally administered once-daily, that inhibits B-cell antigen receptor signaling downstream of Bruton's tyrosine kinase (BTK). Ibrutinib has been approved in USA in February 2014 and in France in October 2014 for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL) and for the treatment of patients with CLL and a chromosome 17 deletion (del 17p) or TP53 mutation. In clinical studies, ibrutinib induced an impressive overall response rate (68%) in patients with relapsed/refractory MCL (phase II study). In CLL, ibrutinib has shown to significantly improve progression-free survival, response rate and overall survival in patients with relapsed/refractory CLL, including in those with del 17p. Ibrutinib had an acceptable tolerability profile. Less than 10% of patients discontinued their treatment because of adverse events. Results are pending in other B-cell lymphomas subtypes such as in diffuse large B-cell lymphoma and in follicular lymphoma. An approval extension has already been enregistered for Waldenström disease in USA in January 2015. Given its efficacy and tolerability, ibrutinib is an emerging treatment option for patients with B-cell malignancies.
Ibrutinib: first global approval. [2022]Ibrutinib (Imbruvica™) is a small molecule, first-in-class, once-daily, orally available, Bruton's tyrosine kinase inhibitor that is under development for the treatment of B cell malignancies, including chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL), as well as multiple myeloma (MM), follicular lymphoma (FL) and Waldenstrom's macroglobulinemia (WM). It has been developed by Pharmacyclics, Inc. and Janssen Biotech, Inc. Ibrutinib acts by blocking B-cell antigen receptor signalling, thereby reducing malignant proliferation of B cells and inducing cell death. Based chiefly on findings from a phase Ib/II study, ibrutinib has been approved in the USA for the treatment of MCL in previously treated patients and is one of the first approvals through the US FDA's Breakthrough Therapy Designation Pathway. An application has been filed in the EU seeking regulatory approval in this indication. In both the USA and EU, further applications have been filed with regulatory bodies seeking approval for the use of ibrutinib in patients with previously treated CLL/small lymphocytic lymphoma (SLL). Phase III trials are underway worldwide to evaluate ibrutinib in the treatment of patients with CLL/SLL, DLBCL and MCL, and the agent is in phase II development for use in WM, FL and MM. This article summarizes the milestones in the development of ibrutinib leading to its first approval in MCL.
A review of a novel, Bruton's tyrosine kinase inhibitor, ibrutinib. [2021]Ibrutinib, a Bruton's kinase inhibitor, was granted an accelerated approval by the US Food and Drug Administration in November, 2013, for the treatment of relapsed or refractory mantle cell lymphoma and subsequently for the treatment of relapsed refractory chronic lymphocytic leukemia in February, 2014. In the pivotal phase 2 study of 111 patients with relapsed or refractory mantle cell lymphoma, the overall response rate in patients who received ibrutinib 560 mg daily was 68%. The median progression-free survival was 13.9 months, and the overall survival was 58% at 18 months. In a recently published phase 3 trial (RESONATE) that compared ibrutinib and ofatumumab for the treatment of relapsed and refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, ibrutinib at the daily dosage of 420 mg demonstrated a significantly higher overall response rate (43% in ibrutinib vs. 4% in ofatumumab) and a significantly improved overall survival at 12 months (90% ibrutinib vs. 81% ofatumumab). Similar clinical benefits were shown regardless of del (17 p). Ibrutinib was well tolerated, and dose-limiting toxicity was not observed. Ibrutinib has shown durable remission, improved progression-free survival and overall survival, and favorable safety profile in indolent B-cell lymphoid malignancies. Ibrutinib, as a monotherapy, is an effective treatment modality as a salvage therapy for treatment of mantle cell lymphoma and chronic lymphocytic leukemia / small lymphocytic lymphoma, particularly in older patients (age ≥70 years) who are not a candidate for intensive chemotherapy and/or those with del (17 p). In patients with chronic lymphocytic leukemia and del (17 p), the current practice guideline recommends ibrutinib as an upfront treatment option. Current on-going trials will further define its role as upfront therapy and/or as a combination therapy in indolent B-cell lymphoid malignancies.
Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia. [2021]Ibrutinib (Imbruvica): a novel targeted therapy for chronic lymphocytic leukemia.
Imbruvica®▾(ibrutinib) patient support programme for chronic lymphocytic leukaemia and mantle cell lymphoma. [2021]Single-agent ibrutinib is an effective therapy for three types of non-Hodgkin lymphoma: chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma, both in relapsed and refractory cases and as a frontline treatment; relapsed and refractory mantle cell lymphoma; and Waldenstrom's macroglobulinaemia in patients who have been treated previously with a different medication. This novel agent has changed the landscape for the aforementioned three subtypes of lymphoma therapies as an oral alternative to traditional chemoimmunotherapy. You&i™ is a no-cost support programme, funded by Janssen, that connects patients taking Imbruvica with a nurse who can answer their questions and help address treatment challenges. This programme offers patients information about their disease, their treatment regimen and side effects management by telephone. The You&i programme was tested at an NHS hospital. Case studies of patients and feedback from health professionals who have used this service show its potential benefits to the patient experience and service delivery.
Ibrutinib: A Review in Chronic Lymphocytic Leukaemia. [2021]Ibrutinib (Imbruvica®) is an oral irreversible inhibitor of Bruton's tyrosine kinase, a B-cell receptor (BCR) signalling kinase expressed by various haematopoietic cells, B-cell lymphomas and leukaemias. The drug is indicated for the treatment of certain haematological malignancies, including chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), which are the focus of this review. In phase III CLL/SLL trials, ibrutinib monotherapy was more effective than chlorambucil in the first-line treatment of elderly patients (RESONATE-2) and more effective than ofatumumab in previously-treated adults (RESONATE). Likewise, a combination of ibrutinib, bendamustine and rituximab was more effective in previously-treated adults than bendamustine plus rituximab in a phase III placebo-controlled study (HELIOS). These ibrutinib regimens were associated with significantly better progression-free survival, overall response rates, and overall survival than the comparators (in protocol-specified or planned analyses), with ibrutinib therapy providing benefit regardless of adverse prognostic factors, such as del(17p)/TP53 mutation and del(11q). Ibrutinib has an acceptable tolerability profile, although certain adverse events (e.g. bleeding and atrial fibrillation) require consideration. Redistribution lymphocytosis can occur, but is not indicative of disease progression. Although longer-term data would be beneficial, ibrutinib is a welcome treatment option for patients with CLL, including those who have higher-risk disease or are less physically fit. Indeed, current EU and US guidelines recommend/prefer the drug for the first- and/or subsequent-line treatment of certain patients, including those with del(17p)/TP53 mutation.
Spontaneous Iliopsoas Muscle Hemorrhage Secondary to Ibrutinib (Imbruvica; Pharmacyclics): Brief Report. [2018]Ibrutinib (Imbruvica; Pharmacyclics) is the first Food and Drug Administration-approved inhibitor of Burton's tyrosine kinase (BTK). Attenuation of BTK signaling ultimately leads to inhibition of B-cell proliferation and apoptosis. After a series of clinical trials, the Food and Drug Administration approved ibrutinib in patients with relapsed chronic lymphocytic leukemia in 2014 and Waldenström's macroglobulinemia in 2015. Those trials included rare grade 3+ hemorrhagic events associated with ibrutinib. Herein, we report a unique presentation of back pain due to iliopsoas muscle hemorrhage in a patient with Waldenström's macroglobulinemia after initiation of ibrutinib.