Ibrutinib + Venetoclax for Leukemia
(TAILOR Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination Ibrutinib and Venetoclax for leukemia?
Research shows that the combination of Ibrutinib and Venetoclax improves outcomes in patients with chronic lymphocytic leukemia (CLL), achieving high rates of undetectable disease and potentially leading to durable treatment-free remission. This combination has also shown promising results in other conditions like mantle cell lymphoma, suggesting its effectiveness in treating certain types of leukemia.12345
Is the combination of Ibrutinib and Venetoclax generally safe for humans?
The combination of Ibrutinib and Venetoclax has shown a manageable safety profile in treating certain types of leukemia, with some patients experiencing side effects like tumor lysis syndrome (a condition where cancer cells break down rapidly) and dose-limiting toxicities. However, no new safety concerns were observed in recent studies, suggesting it is generally safe for use in humans.12367
What makes the drug combination of Ibrutinib and Venetoclax unique for treating leukemia?
The combination of Ibrutinib and Venetoclax is unique because it has shown promising results in improving outcomes for patients with chronic lymphocytic leukemia (CLL), especially those who are resistant to other treatments. This combination offers a potential new standard treatment option with a manageable safety profile, even in high-risk or relapsed cases.12358
Research Team
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for adults with untreated chronic lymphocytic leukemia who are not pregnant or breastfeeding, agree to use contraception, and have a certain level of physical function (ECOG status). They must have measurable disease by CT scan. People planning pregnancy soon after the study or those with other health conditions that could interfere are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ibrutinib and venetoclax with dosing adjustments based on cohort assignment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ibrutinib
- Venetoclax
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires
Pharmacyclics LLC.
Industry Sponsor
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