A Phase 3 interventional study of Duvelisib and Gemcitabine in Lymphoma, sponsored by SecuraBio. Recruiting at 44 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by SecuraBio · Phase 3, Interventional, and Treatment
The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 124 is above the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →SecuraBio is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Duvelisib will be administered orally twice daily (BID) in 28-day cycles.
Drug: Duvelisib
Participants will receive the investigator's choice of gemcitabine or bendamustine. The regimen to be used after randomization must be selected by the investigator prior to randomization. Gemcitabine will be administered intravenously (IV) on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles. Bendamustine will be administered IV on days 1 and 2 of each 21-day cycle for up to 6 cycles.
Drug: Gemcitabine · Drug: Bendamustine
oral capsules
solution for intravenous infusion
solution for intravenous infusion
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
PFS as assessed by the investigator
Time frame: Up to 3 years
Objective Response Rate (ORR) as assessed by the IRC
Time frame: Up to 3 years
Complete Response Rate (CRR) as assessed by the IRC
Time frame: Up to 3 years
Duration of Response (DOR) as assessed by the IRC
Time frame: Up to 3 years
Proportion of participants who proceed to Stem Cell Transplantation (SCT)
Time frame: Up to 3 years
Investigator-assessed PFS in participants who proceed to SCT
Time frame: Up to 3 years
Number of participants with Adverse Events (AEs)
Time frame: Up to 3 years
Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score
Time frame: Up to 3 years
QoL: EQ5D Score
Time frame: Up to 3 years
QoL: QLQ-NHL-HG29 Score
Time frame: Up to 3 years
Concentration of Duvelisib and its Metabolites in Blood
Time frame: Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose)
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Feb 2028, 33 months after the start.
Of 29 industry-sponsored phase 3 interventional studies under Lymphoma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 69. This study's planned 33 months is below that.
Counting every sponsor, half of 62 studies reached it within 67 months; a quarter within 52 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Duvelisib