T-cell-prolymphocytic LeukemiaPhase 1/2NCT06810778
Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Phase 1/2 study testing Duvelisib and Venetoclax in people with T-cell-prolymphocytic Leukemia and Cutaneous T-Cell Lymphoma Refractory, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is an open-label, phase I/II study of duvelisib in combination with Venetoclax for patients with relapsed/refractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell-prolymphocytic Leukemia, Cutaneous T-Cell Lymphoma Refractory
- What is being tested?
- Duvelisib and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2025to 1 Jun 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase I: Histologically confirmed relapsed/refractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).
- Phase II: same as phase I
- Disease that has progressed during or relapsed after at least two previous therapies.
- ECOG performance status ≤ 2
- Adequate hepatic function defined as:
- o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
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- Adequate renal function as defined by:
- o Creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
- Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy:
- Absolute neutrophil count ≥ 1500 cells/mm3 (1.5 x 109/L) or ≥ 1000 cells/mm3 (1.5 x 109/L) with bone marrow involvement. Growth factor use is allowed in order to achieve this
- Platelet count ≥ 50,000 cells/mm3 (50 x 109/L) independent of transfusion within 7 days of screening
- Hemoglobin ≥8 g/dL (without transfusion support.)
Who cannot join
- Phase I and Phase II:
- Patients eligible for Hematopoietic stem cell transplantation (HSCT)
- Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL)
- Suspected and confirmed central nervous system involvement
- Previous treatment with venetoclax or a PI3K inhibitor.
- Active malignancy other than NHL requiring ongoing therapy, with the exception of hormonal therapy (i.e. castration-sensitive prostate cancer stable on testosterone blockade)
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- Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery) within 2 weeks of Cycle 1/Day 1 with the following exceptions:
- For patients on targeted therapies, a washout of least five half-lives is required
- Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI
- Corticosteroid therapy (prednisone or equivalent <20 mg daily) is allowed
- Patients with multiple basal cell carcinomas that undergo sequential Moh's excisions with interim observation
- Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis
- o Patients with a history of an allogeneic stem cell transplant > 6 months prior to starting study treatment should be stable, off of immunosuppression for at least 2 months.
- Any active systemic infection requiring systemic antibiotics or other uncontrolled, active infections
- Positive Human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) antibody test
- o For HCV and HBV, patients with evidence of prior infection also excluded
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
- Uncontrolled, not disease-related autoimmune hemolytic anemia or ITP
- History of stroke or intracranial hemorrhage
- History of severe bleeding disorder (hemophilia A or B, von Willebrand disease (VWD)), history of spontaneous bleeding requiring blood transfusions or other medical intervention, history of life-threatening hemorrhage within 3 months of first dose.
- Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
- Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina
- Use of Coumadin for anticoagulation (other anticoagulants permitted)
- Lactating or pregnant
- Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea
- Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D)
- Treatment with any of the following within 7 days prior to the first dose of study drug:
- Steroid therapy for anti-neoplastic intent (defined as prednisone or equivalent >20 mg daily)
- Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix D for examples)
- Moderate or strong CYP3A inducers (see Appendix D for examples)
- Administration or consumption of any of the following within 7 days prior to the first dose of study drug:
- Grapefruit or grapefruit products
- Seville oranges (including marmalade containing Seville oranges)
- Star fruit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vanessa Crowell contact
United States1 site, 1 recruiting
- Recruiting
David Geffen School of Medicine at the University of California at Los Angeles
Los Angeles, California, 90095-1406
Vanessa Crowell, 424-440-0843, vcrowell@mednet.ucla.edu
Vladimir Bonhomme, 310-794-6500, vbonhomme@mednet.ucla.edu
About this study
Official title: Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
This is an open-label, phase I/II study of duvelisib in combination with Venetoclax for patients with relapsed/refractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.
Read the detailed description
In this phase I/II trial, we combine duvelisib and venetoclax in patients with relapsed/refractory Peripheral T-cell lymphoma (PTCL). Researchers aim to determine the maximum tolerated doses (MTD) of duvelisib in combination with venetoclax, the safety of combination therapy, and preliminary efficacy data in Peripheral T-cell lymphoma (PTCL).
Patients with PTCL would be offered the option to remain on treatment beyond 2 years if they are clinically benefitting, complete response, partial response, stable disease (CR, PR, SD).
The phase I portion of the trial will determine the dose, schedule, safety, and tolerability of duvelisib in combination with venetoclax.
Phase I:
In the phase I study, 2 dose levels of duvelisib (15 and 25 mg BID) and 3 dose levels of venetoclax (200, 400, and 800 mg QD) will be evaluated. Patients will start with 15 mg BID of duvelisib and 200 mg QD of venetoclax. We use a traditional 3 + 3 design to accrue patients to each combination cohort. There are 5 possible dosing combinations to be tested, with up to 18 patients planned to be enrolled. Enrollment may stop early based on DLTs. The DLT assessment window is defined as Day 1-21 of Cycle 1 (21 days). De-escalation will occur if unexpected toxicity is observed and both drugs will be reduced for the next lower dosing cohort. Increasing drug dosing levels will be performed in parallel cohorts, each increasing either venetoclax or duvelisib (see Dosing Schema).
The following lymphoma subtypes will be excluded due to potential tumor lysis risk: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).
Patients in the initial dosing cohorts will start at a lower dose of venetoclax than the tested dose in phase 2 trials dose (800 mg QD) and at a lower dose of duvelisib than the recommended phase 2 dose (25 mg BID). Once the RP2D of combination duvelisib plus venetoclax is determined, patients assigned to lower dose levels in the phase I trial will have the option to escalate their duvelisib and venetoclax doses to the RP2D.
Planned Phase II (dependent on phase I data and new discussions with AbbVie and Secura Bio):
The phase II study will only proceed after discussion of Phase I results with study investigators, DSMB, AbbVie, and Secura Bio and will enroll patients with relapsed/refractory PTCL at the RP2D.
Phase II will start once phase I data have been reviewed by AbbVie and Secura Bio, DSMB, and FDA, and proceeding to the next phase has been approved.
Study visits will occur weekly through cycles 1-2, once per cycle during cycles 3-7, every 2 cycles from cycle 8-13, and every 3 cycles thereafter.
- Being tested
- Duvelisib, Venetoclax
- Keywords
- leukemia, refractory, relapsed
- Medical subject headings
- Leukemia, Prolymphocytic, T-Cell, Leukemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
15 and 25 mg BID
VenetoclaxDrug
200, 400, and 800 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Arm Treatment (Duvelisib and Venetoclax) | Experimental | Phase I:
In the phase I study, 2 dose levels of duvelisib (15 and 25 mg BID) and 3 dose levels of venetoclax (200, 400, and 800 mg QD) will be evaluated. Patients will start with 15 mg BID of duvelisib and 200 mg QD of venetoclax. We use a traditional 3 + 3 design to accrue patients to each combination cohort. There are 5 possible dosing combinations to be tested, with up to 18 patients planned to be enrolled. Enrollment may stop early based on DLTs. The DLT assessment window is defined as Day 1-21 of Cycle 1 (21 days). De-escalation will occur if unexpected toxicity is observed and both drugs will be reduced for the next lower dosing cohort. Increasing drug dosing levels will be performed in parallel cohorts, each increasing either venetoclax or duvelisib. Receives: Drug: Duvelisib; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the dose limiting toxicities (DLTs), for the combination regimen of duvelisib plus venetoclax for patients with relapsed or refractory PTCL
Phase I:
Will be graded according to the Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 21 days
Determine the Maximum Tolerated Dose MTD)
Phase I:
Will be defined as the highest dose studied for which the observed incidence of DLT is less than 33%. Frequencies of toxicities will be tabulated according to the National Cancer Institute Common Toxicity Criteria.
Measured: Up to 21 days
Recommended phase II dose (Phase I)
Phase I
Measured: Up to 21 days
Secondary outcomes (10)
Overall response rate
Phase II:
Will be assessed according to Lugano criteria. Will be based on exact one-sided binomial tests (Simon two-stage designs) within each of the disease groups. Will be estimated with exact 95% confidence intervals.
Measured: up to 1 year
Objective response rate
Phase II:
Will be defined as proportion of patients who achieve a complete and partial response. Will be estimated along with a 95% confidence interval
Measured: Up to 1 year
Duration of response
Phase II:
Will be calculated using Kaplan-Meier methodology.
Measured: From the date of response to the date of progression of disease, assessed up to 1 year
Progression free survival
Phase II:
Will be calculated using Kaplan-Meier methodology.
Measured: From start of treatment to the date of progression, death or last follow-up, assessed up to 1 year
Overall survival
Phase II:
Will be calculated using Kaplan-Meier methodology.
Measured: From the start of treatment to the date of death or last follow-up, assessed up to 1 year
Pharmacokinetic parameters: Half-life
Phase II:
Will include half-life determined using non-compartmental methods. Standard descriptive statistics (mean, standard deviation, median, range) will be presented on all parameters.
Measured: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Maximum concentration
Phase II:
Will include maximum concentration determined using non-compartmental methods. Standard descriptive statistics (mean, standard deviation, median, range) will be presented on all parameters.
Measured: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Area under the curve
Phase II:
Will include area under the curve determined using non-compartmental methods. Standard descriptive statistics (mean, standard deviation, median, range) will be presented on all parameters.
Measured: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Volume of distribution
Phase II:
Will include volume of distribution determined using non-compartmental methods. Standard descriptive statistics (mean, standard deviation, median, range) will be presented on all parameters.
Measured: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Clearance
Phase II:
Will include clearance determined using non-compartmental methods. Standard descriptive statistics (mean, standard deviation, median, range) will be presented on all parameters.
Measured: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start2 May 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell-prolymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810778
- Sponsor's protocol ID
- 24-001373
- Other IDs
- NCI-2025-00574
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT06810778
- Acronym / sponsor ID
- 24-001373
- Keywords
- leukemia, refractory, relapsed
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, phase I/II study of duvelisib in combination with Venetoclax for patients with relapsed/refractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.
Detailed description
In this phase I/II trial, we combine duvelisib and venetoclax in patients with relapsed/refractory Peripheral T-cell lymphoma (PTCL). Researchers aim to determine the maximum tolerated doses (MTD) of duvelisib in combination with venetoclax, the safety of combination therapy, and preliminary efficacy data in Peripheral T-cell lymphoma (PTCL).
Patients with PTCL would be offered the option to remain on treatment beyond 2 years if they are clinically benefitting, complete response, partial response, stable disease (CR, PR, SD).
The phase I portion of the trial will determine the dose, schedule, safety, and tolerability of duvelisib in combination with venetoclax.
Phase I:
In the phase I study, 2 dose levels of duvelisib (15 and 25 mg BID) and 3 dose levels of venetoclax (200, 400, and 800 mg QD) will be evaluated. Patients will start with 15 mg BID of duvelisib and 200 mg QD of venetoclax. We use a traditional 3 + 3 design to accrue patients to each combination cohort. There are 5 possible dosing combinations to be tested, with up to 18 patients planned to be enrolled. Enrollment may stop early based on DLTs. The DLT assessment window is defined as Day 1-21 of Cycle 1 (21 days). De-escalation will occur if unexpected toxicity is observed and both drugs will be reduced for the next lower dosing cohort. Increasing drug dosing levels will be performed in parallel cohorts, each increasing either venetoclax or duvelisib (see Dosing Schema).
The following lymphoma subtypes will be excluded due to potential tumor lysis risk: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).
Patients in the initial dosing cohorts will start at a lower dose of venetoclax than the tested dose in phase 2 trials dose (800 mg QD) and at a lower dose of duvelisib than the recommended phase 2 dose (25 mg BID). Once the RP2D of combination duvelisib plus venetoclax is determined, patients assigned to lower dose levels in the phase I trial will have the option to escalate their duvelisib and venetoclax doses to the RP2D.
Planned Phase II (dependent on phase I data and new discussions with AbbVie and Secura Bio):
The phase II study will only proceed after discussion of Phase I results with study investigators, DSMB, AbbVie, and Secura Bio and will enroll patients with relapsed/refractory PTCL at the RP2D.
Phase II will start once phase I data have been reviewed by AbbVie and Secura Bio, DSMB, and FDA, and proceeding to the next phase has been approved.
Study visits will occur weekly through cycles 1-2, once per cycle during cycles 3-7, every 2 cycles from cycle 8-13, and every 3 cycles thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Treatment (Duvelisib and Venetoclax) | Experimental | Drug: Duvelisib, Drug: VenetoclaxPhase I: In the phase I study, 2 dose levels of duvelisib (15 and 25 mg BID) and 3 dose levels of venetoclax (200, 400, and 800 mg QD) will be evaluated. Patients will start with 15 mg BID of duvelisib and 200 mg QD of venetoclax. We use a traditional 3 + 3 design to accrue patients to each combination cohort. There are 5 possible dosing combinations to be tested, with up to 18 patients planned to be enrolled. Enrollment may stop early based on DLTs. The DLT assessment window is defined as Day 1-21 of Cycle 1 (21 days). De-escalation will occur if unexpected toxicity is observed and both drugs will be reduced for the next lower dosing cohort. Increasing drug dosing levels will be performed in parallel cohorts, each increasing either venetoclax or duvelisib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Phase I: Histologically confirmed relapsed/refractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).
- Phase II: same as phase I
- Disease that has progressed during or relapsed after at least two previous therapies.
- ECOG performance status ≤ 2
- Adequate hepatic function defined as:
Key exclusion criteria (37 listed)
- Phase I and Phase II:
- o Patients with a history of an allogeneic stem cell transplant > 6 months prior to starting study treatment should be stable, off of immunosuppression for at least 2 months.
- o For HCV and HBV, patients with evidence of prior infection also excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duvelisib15 and 25 mg BID | Drug | Arm Treatment (Duvelisib and Venetoclax) |
| Venetoclax200, 400, and 800 mg QD | Drug | Arm Treatment (Duvelisib and Venetoclax) |
Primary outcome
Determine the dose limiting toxicities (DLTs), for the combination regimen of duvelisib plus venetoclax for patients with relapsed or refractory PTCL
Time frame: Up to 21 days
Phase I: Will be graded according to the Common Terminology Criteria for Adverse Events version 5.0.
Determine the Maximum Tolerated Dose MTD)
Time frame: Up to 21 days
Phase I: Will be defined as the highest dose studied for which the observed incidence of DLT is less than 33%. Frequencies of toxicities will be tabulated according to the National Cancer Institute Common Toxicity Criteria.
Recommended phase II dose (Phase I)
Time frame: Up to 21 days
Phase I
10 secondary outcomes
Overall response rate
Time frame: up to 1 year
Objective response rate
Time frame: Up to 1 year
Duration of response
Time frame: From the date of response to the date of progression of disease, assessed up to 1 year
Progression free survival
Time frame: From start of treatment to the date of progression, death or last follow-up, assessed up to 1 year
Overall survival
Time frame: From the start of treatment to the date of death or last follow-up, assessed up to 1 year
Pharmacokinetic parameters: Half-life
Time frame: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Maximum concentration
Time frame: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Area under the curve
Time frame: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Volume of distribution
Time frame: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Pharmacokinetic parameters: Clearance
Time frame: At days 1, 8, and 15 of cycle 1 (1 cycle = 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanessa Crowell contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Duvelisib and Venetoclax in people with T-cell-prolymphocytic Leukemia and Cutaneous T-Cell Lymphoma Refractory, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Bonhomme (310-794-6500, VBonhomme@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the dose limiting toxicities (DLTs), for the combination regimen of duvelisib plus venetoclax for patients with relapsed or refractory PTCL (time frame: Up to 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.