Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Duvelisib
Drug15 and 25 mg BID
Venetoclax
Drug200, 400, and 800 mg QD
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Arm Treatment (Duvelisib and Venetoclax)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 21 days2
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.
Time frame
Up to 21 days3
Recommended phase II dose (Phase I)
Phase I
Time frame
Up to 21 daysSecondary outcomes
1
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.
Time frame
up to 1 year2
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
Time frame
Up to 1 year3
Duration of response
Phase II: Will be calculated using Kaplan-Meier methodology.
Time frame
From the date of response to the date of progression of disease, assessed up to 1 year4
Progression free survival
Phase II: Will be calculated using Kaplan-Meier methodology.
Time frame
From start of treatment to the date of progression, death or last follow-up, assessed up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov