Tolinapant + Decitabine/Cedazuridine for Peripheral T-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
The primary purpose of the study is to assess safety, and to identify the recommended phase 2 dose (RP2D) of tolinapant in combination with oral decitabine/cedazuridine in Phase 1 and to assess preliminary efficacy as determined by overall response rate (ORR) in Phase 2.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot use certain medications like CYP3A4 inhibitors/inducers within 2 weeks of starting the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.
What data supports the effectiveness of the drug Tolinapant + Decitabine/Cedazuridine for Peripheral T-Cell Lymphoma?
Research shows that decitabine, a component of the treatment, has been effective in treating other blood cancers like acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), with significant improvements in survival and response rates. Additionally, decitabine has shown potential when combined with other agents in treating peripheral T-cell lymphoma, suggesting it could be beneficial in this new combination.12345
What safety data exists for Tolinapant + Decitabine/Cedazuridine treatment?
The combination of decitabine and cedazuridine has been studied for safety in conditions like myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Common serious side effects included low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and fever with low white blood cell counts (febrile neutropenia).12367
What makes the drug Tolinapant + Decitabine/Cedazuridine unique for treating Peripheral T-Cell Lymphoma?
This drug combination is unique because it combines Tolinapant, which may enhance the effectiveness of other cancer treatments, with Decitabine/Cedazuridine, an oral formulation that increases the bioavailability of Decitabine, a DNA methyltransferase inhibitor. This combination could potentially offer a more effective and convenient oral treatment option for Peripheral T-Cell Lymphoma, a condition with limited standard treatments.12389
Eligibility Criteria
This trial is for people with a specific type of cancer called Peripheral T-cell Lymphoma (PTCL) that has come back or didn't respond to treatment. They should have tried at least two treatments before, be expected to live more than 12 weeks, and not be pregnant or breastfeeding. They can't join if they've had certain heart problems, uncontrolled infections, significant mental illness or substance abuse issues, other active cancers needing treatment (except some breast/prostate/bladder cancers), recent other cancer treatments like chemotherapy or CAR-T therapy within specified time frames, known HIV/HBV/HCV infection, CNS lymphoma history, allogeneic transplant history or autotransplant within the last 100 days.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive tolinapant in combination with oral decitabine/cedazuridine to determine the recommended phase 2 dose (RP2D)
Phase 2 Treatment
Participants receive tolinapant at the identified RP2D in combination with decitabine/cedazuridine
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Decitabine + Cedazuridine
- Tolinapant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Taiho Oncology, Inc.
Lead Sponsor
Tim Whitten
Taiho Oncology, Inc.
Chief Executive Officer since 2018
MBA and Pharmacy degree
Harold Keer
Taiho Oncology, Inc.
Chief Medical Officer
MD, PhD
Astex Pharmaceuticals, Inc.
Lead Sponsor
Dr. Harren Jhoti
Astex Pharmaceuticals, Inc.
Chief Executive Officer since 2007
PhD in Biochemistry from Birkbeck College, London
Dr. Harold N. Keer
Astex Pharmaceuticals, Inc.
Chief Medical Officer since 2020
MD