Actively Recruiting
A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma
Led by City of Hope Medical Center ยท Updated on 2026-06-02
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating duvelisib as a maintenance treatment for patients with peripheral T-cell lymphomas who have achieved complete response after their initial therapy but cannot or choose not to undergo stem cell transplantation. This phase II trial aims to determine the effectiveness and safety of duvelisib in preventing cancer from returning. The study also explores the relationship between certain biomarkers and clinical outcomes such as response rates and survival. Participants receive duvelisib orally twice daily for 28 days per cycle, with cycles repeating every 28 days for up to one year if no disease progression or unacceptable side effects occur. Those maintaining continuous complete response may continue treatment for up to an additional 13 cycles. During the study, patients undergo bone marrow tests, PET/CT scans, and blood sample collections to monitor their condition and treatment effects. After finishing the duvelisib treatment, participants are followed up at 4 to 6 weeks, then periodically for up to five years. Assessments include progression-free survival at one year, tolerability, patient-reported outcomes, time to next therapy, overall survival, and other health evaluations. This long-term monitoring helps researchers understand the treatment's impact and safety over time.
CONDITIONS
Brief Title
Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and assent when appropriate
- Age 18 years or older
- ECOG performance status 2 or less
- Histologically confirmed nodal T-follicular helper cell lymphomas or peripheral T-cell lymphoma not otherwise specified
- Completed first-line CHOP-based chemotherapy with documented complete response within 6 months
- Ineligible for or declined autologous stem cell transplantation
- Recovered to grade 1 or baseline for prior treatment toxicities except peripheral neuropathy (grade 2) or alopecia
- Platelet count at least 25,000/mm3
- Hemoglobin level at least 8 g/dL
- CD4 lymphocyte count at least 50/mm3
- Liver and kidney function within specified limits
- Negative for HIV, hepatitis C, active hepatitis B or under monitoring for hepatitis B
- Women of childbearing potential must have negative pregnancy test and agree to contraception
- Agreement to use effective contraception during and 1 month after treatment
You will not qualify if you...
- Prior organ transplantation
- Major surgery within 4 weeks before enrollment
- Live vaccine within 30 days before first treatment
- Unable to receive prophylaxis for pneumocystis
- Use of strong CYP3A inducers or inhibitors within 2 weeks before treatment
- Known central nervous system involvement by lymphoma
- Active cytomegalovirus infection
- Recent tuberculosis treatment
- Active infections requiring systemic treatment
- History of cirrhosis or chronic alcohol abuse
- Symptomatic inflammatory bowel disease or gastrointestinal disorders affecting drug absorption
- Concurrent active malignancy affecting study compliance (except certain skin and cervical cancers)
- Significant uncontrolled diseases like severe lung, heart, or psychiatric conditions
- Abnormal ECG findings deemed clinically significant
- History of allergic reactions to similar compounds
- Receiving other investigational agents
- Breastfeeding women
- Conditions or factors that may interfere with study participation or compliance as judged by the investigator
- Inability to comply with all study procedures due to feasibility or logistics issues
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive duvelisib orally twice daily in 28-day cycles for up to 1 year, with the option to continue for an additional 13 cycles if they remain in complete response without disease progression or unacceptable toxicity.
Repeated 28-day cycles with visits at day 1 of each cycle and assessments throughout
Duration - Up to 5 years
After completing treatment, participants are followed up at 4 to 6 weeks and then periodically for up to 5 years to monitor health and survival outcomes.
Periodic visits after treatment completion
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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