Duvelisib for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how well the drug duvelisib prevents T-cell lymphoma from returning after it disappears following initial treatment. Duvelisib blocks signals that cause cancer cells to grow, potentially stopping their spread. The trial targets individuals with peripheral T-cell lymphomas who have completed their first round of chemotherapy and are in complete remission. It is particularly suited for those who cannot or choose not to undergo a stem cell transplant, another treatment option. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop taking my current medications to join the trial?
The trial requires you to stop taking medications or foods that strongly affect CYP3A enzymes at least 2 weeks before starting the study. If you need to take a strong CYP3A4 inhibitor for a fungal infection during the trial, your dose may need to be adjusted.
Is there any evidence suggesting that duvelisib is likely to be safe for humans?
Research has shown that duvelisib is generally well-tolerated by patients. In earlier studies, many people took the medication without serious issues. Common side effects included diarrhea, tiredness, and nausea, but these were usually manageable.
Another study found that duvelisib had an acceptable safety profile, meaning most side effects were not severe. Most patients continued taking the medication even if they experienced some discomfort.
While duvelisib is still being tested for T-cell lymphoma, it is already approved for other conditions. This approval indicates it is safe enough for use in those cases, although each condition can present different risks.
Overall, evidence suggests that duvelisib may be a safe option for many patients, but discussing potential side effects with a healthcare provider is important.12345Why do researchers think this study treatment might be promising?
Most treatments for T-cell lymphoma, like chemotherapy and radiation, aim to destroy cancer cells but often affect healthy cells too. Duvelisib is unique because it is a targeted therapy that specifically inhibits PI3K enzymes, which play a crucial role in the growth and survival of cancer cells. This targeted approach may lead to fewer side effects and improved effectiveness compared to traditional treatments. Researchers are excited about duvelisib because it offers a new way to attack the cancer with potentially better outcomes for patients.
What evidence suggests that duvelisib might be an effective treatment for T-cell lymphoma?
Research has shown that duvelisib, the treatment under study in this trial, may help treat T-cell lymphomas. In earlier studies, about 48% of patients showed improvement, meaning nearly half got better. Additionally, around 33% of patients experienced a complete response, with their cancer symptoms disappearing entirely. This treatment blocks signals that help cancer cells grow, potentially stopping the disease from spreading. These results suggest that duvelisib might be effective in preventing cancer from returning after the initial treatment.678910
Who Is on the Research Team?
Christina Poh
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with peripheral T-cell lymphomas who have responded to initial therapy and are in need of maintenance treatment. Participants must be able to undergo procedures like bone marrow biopsy and imaging tests such as CT and PET scans.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive duvelisib orally twice daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year.
Extension
Participants who remain in continuous complete response may continue to receive duvelisib for an additional 13 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Duvelisib
Trial Overview
The trial is testing duvelisib, a kinase inhibitor, as a maintenance therapy to prevent the return of cancer after successful initial treatment. It involves regular monitoring through biospecimen collection, bone marrow aspiration/biopsy, and imaging studies.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive duvelisib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who remain in continuous complete response may continue to receive duvelisib for an additional 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy during screening, as well as PET/CT scans and blood sample collection throughout the study. Patients may also undergo bone marrow aspiration and biopsy on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
1.
ashpublications.org
ashpublications.org/bloodadvances/article/9/16/4286/537797/Real-world-evidence-of-duvelisib-and-romidepsin-inReal-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) ...
Duvelisib in Patients with Relapsed/Refractory Peripheral T ...
The median follow-up for PFS was 6.24 mo. Efficacy outcomes: ORR: 48%, complete response rate (CRR): 33%, median progression-free survival (mPFS): ...
Duvelisib plus Romidepsin in relapsed/refractory T cell ...
Preclinical studies indicated that duvelisib is effective in T-cell lymphomas with constitutive PI3K activation, inducing cell death in 3 out of 4 lymphoma ...
TERZO Trial Seeks to Validate Duvelisib as an Effective ...
Previously reported data from PRIMO demonstrated an overall response rate of 48% and a complete response rate of 33.3% with duvelisib (n = 123).
Utility of Low-Dose Duvelisib for Advanced Mycosis Fungoides
Specifically, a recent phase I trial demonstrated the efficacy of duvelisib in peripheral T-cell lymphomas and cutaneous T-cell lymphomas, ...
6.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/3061/533672/Duvelisib-in-Patients-with-Relapsed-RefractoryDuvelisib in Patients with Relapsed/Refractory Peripheral T ...
Efficacy outcomes: ORR: 48%, complete response rate (CRR): 33%, median progression-free survival (mPFS): 3.45 mo, median duration of response ( ...
Safety and efficacy of dual PI3K-δ, γ inhibitor, duvelisib in ...
This systematic review and meta-analysis aimed to evaluate the safety and efficacy of duvelisib in treating different relapsed or refractory (RR) lymphoid ...
Duvelisib in patients with relapsed/refractory peripheral T ...
Median follow-up time was 11.5 mos; median treatment duration was 8.3 weeks. Efficacy outcomes were ORR 48%, complete response rate (CRR) 33%, ...
NCT03372057 | A Study of Duvelisib in Participants With ...
This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of phosphoinositide-3-kinase-delta, gamma (PI3K-δ,γ), in ...
The PRIMO study: A phase 2 study of duvelisib efficacy and ...
In a Phase 1 study duvelisib monotherapy demonstrated encouraging clinical activity and an acceptable safety profile (Flinn, Blood 2017), with ...
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