Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
This phase II trial tests how well duvelisib works as treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy (maintenance) for patients with peripheral T-cell lymphomas. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented informed consent of the participant and/or legally authorized representative.
Assent, when appropriate, will be obtained per institutional guidelines
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Disqualifiers
Prior organ transplantation
Major surgery within 4 weeks prior to enrollment
Administration of a live vaccine within 30 days of cycle (C) 1 day (D) 1
Unable to receive prophylactic treatment for pneumocystis at enrollment
Trial design
Design model
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow biopsy
Computed Tomography
Procedure/SurgeryUndergo CT scan
Duvelisib
DrugGiven PO
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Survey Administration
Other interventionAncillary studies
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Treatment (duvelisib)Experimental treatment 7 interventions
Trial outcomes
Primary outcomes
1
Progression free survival
Will be estimated by Kaplan-Meier method with a 95% confidence interval.
Time frame
At 1 yearSecondary outcomes
1
Rate of duvelisib discontinuation due to toxicity while receiving therapy (tolerability)
Time frame
Up to 2 years2
Patient-reported outcomes
As measured by the Patient-Reported Outcomes Measurement Information System, Global Health and Functional Assessment of Chronic Illness Therapy-Item GP5 scale.
Time frame
At baseline, day 1 of each cycle and at end of treatment, up to 5 years3
Time to next therapy
The Kaplan-Meier method will be used to estimate the time to event.
Time frame
From starting duvelisib to the start of next treatment, up to 5 years4
Progression free survival
The Kaplan-Meier method will be used to estimate the time to event.
Time frame
From starting duvelisib maintenance therapy to disease progression or death, whichever occurs earlier, up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov