Duvelisib + BMS-986345 for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug combination for individuals with certain types of lymphoma, a cancer affecting the immune system. The goal is to determine a safe dose and assess how well participants tolerate the combination of two drugs, BMS-986345 and duvelisib (also known as Copiktra, an oral medication). It is suitable for those who have tried other lymphoma treatments without success and have no other viable options. Participants should have a measurable tumor and should not have recently undergone a stem cell transplant or certain other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug combination.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot take certain medications like potent CYP3A4 inhibitors or inducers within 14 days before starting the study treatment. It's best to discuss your current medications with the trial team to see if any need to be adjusted.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that duvelisib, one of the treatments in this trial, raised safety concerns in past studies. Specifically, it posed a higher risk of death and serious side effects compared to another cancer medicine. While duvelisib can be effective, it requires careful monitoring due to these potential risks.
Regarding BMS-986345, limited public information exists on its safety because the study involving it remains in an early stage. Early-stage studies typically focus on determining the safest dose and assessing how well participants tolerate the treatment.
In summary, duvelisib presents known risks that require monitoring, and BMS-986345 is still under study to evaluate its safety. Participants should consider these factors when deciding whether to join the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining Duvelisib with BMS-986345 for lymphoma because this treatment approach could offer a new way to tackle the disease. Most treatments for lymphoma focus on disrupting the growth of cancer cells through traditional chemotherapy or monoclonal antibodies. However, Duvelisib is a PI3K inhibitor, targeting specific proteins involved in cancer cell survival, while BMS-986345 is being tested to enhance this effect by working in tandem with Duvelisib. This combination aims to improve effectiveness and potentially reduce the progression of the disease, offering hope for better outcomes compared to existing therapies.
What evidence suggests that this trial's treatments could be effective for lymphoma?
Research has shown that duvelisib, a pill, yields promising results in treating certain blood cancers like lymphoma. In studies, duvelisib effectively targeted cancer in patients who had already received multiple treatments. It blocks specific proteins that aid cancer cell growth. This trial tests the combination of duvelisib with BMS-986345 to determine if it can safely and effectively treat lymphoma. While the effectiveness of BMS-986345 remains under study, combining it with duvelisib might enhance its efficacy.678910
Who Is on the Research Team?
Hayder Saeed, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
Adults with certain types of lymphoid malignancies, including various T-cell lymphomas and B-cell lymphomas, who have progressed after prior therapies. Participants must be over 18, have a performance status indicating they can carry out daily activities with little or no assistance, and not be pregnant or planning to conceive. They should also have adequate organ function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Dose escalation to determine the maximum tolerated dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CC-486
- Duvelisib
Trial Overview
The trial is testing the safety and optimal dose of BMS-986345 when used in combination with duvelisib for treating specific lymphoid cancers. It aims to determine how well patients tolerate this drug combo.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Dose escalation to determine the maximum tolerated dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy. Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 6 dose levels will be used.
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Secura Bio, Inc.
Industry Sponsor
Citations
A Phase II Study of Duvelisib (IPI-145) in Patients With ...
In the DYNAMO study, oral duvelisib monotherapy demonstrated clinically meaningful activity and a manageable safety profile in heavily pretreated, ...
2.
accessdata.fda.gov
accessdata.fda.gov/drugsatfda_docs/nda/2018/211155Orig1Orig2s000MultidisciplineR.pdf211155Orig1s000 211155Orig2s000 - accessdata.fda.gov
The pivotal evidence of effectiveness comes from the efficacy results in Study-IPI-145-07 and Study IPI-145-06. Is the proposed dosing ...
Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical ...
Duvelisib demonstrated favorable clinical activity and an acceptable safety profile in these high‐risk, heavily pretreated, relapsed/refractory iNHL patients.
DYNAMO: A Phase II Study of Duvelisib (IPI-145) in ...
In the DYNAMO study, oral duvelisib monotherapy demonstrated clinically meaningful activity and a manageable safety profile in heavily pretreated, double- ...
A Phase 3 Extension Study of Duvelisib and Ofatumumab ...
A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants with chronic ...
Duvelisib in Combination With BMS-986345 in Lymphoid ...
The purpose of the study is to find a safe dose and to evaluate the safety and tolerability of the drug BMS-986345, in combination with duvelisib. Official ...
7.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/3065/533780/A-Phase-I-Study-of-Duvelisib-in-Combination-withA Phase I Study of Duvelisib in Combination with Oral ...
A Phase I Study of Duvelisib in Combination with Oral Azacitidine (BMS-986345) in Mature T Cell Lymphoma Available ... lymphoma (RR TCL) is a poor ...
Duvelisib + BMS-986345 for Lymphoma · Info for Participants
Trial Overview The trial is testing the safety and optimal dose of BMS-986345 when used in combination with duvelisib for treating specific lymphoid cancers. It ...
Real-world evidence of duvelisib and romidepsin in relapsed ...
A previous phase 1/2 study of duvelisib/romidepsin (duv/romi) reported an overall response rate (ORR) of 58% and a complete response rate (CRR) of 42% with ...
10.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05065866/duvelisib-in-combination-with-bms-986345-in-lymphoid-malignancyDuvelisib in Combination With BMS-986345 in Lymphoid ...
The purpose of the study is to find a safe dose and to evaluate the safety and tolerability of the drug BMS-986345, in combination with ...
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