A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03372057|
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-cell Lymphoma||Drug: Duvelisib||Phase 2|
The study has 2 phases, a Dose Optimization Phase and an Expansion Phase.
In the Dose Optimization Phase, patients will be randomly assigned to 1 of 2 study cohorts, as follows:
- Cohort 1: Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-patient basis to 50 mg and then 75 mg, based on the patient's response to and tolerance of therapy, in 28-day cycles.
- Cohort 2: Duvelisib 75 mg PO BID, administered in 28-day cycles .
A total of 20 patients will be enrolled in the Dose Optimization Phase, with 10 patients per cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the study, the Expansion Phase dose of Duvelisib will be determined.
In the Expansion Phase, approximately 90-100 patients may be enrolled and will receive Duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Dose Optimization Phase: Cohort 1
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-patient basis to 50 mg and then 75 mg, based on the patient's response to and tolerance of therapy, in 28-day cycles.
Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
Experimental: Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
Duvelisib PO 75 mg BID in 28-day cycles.
Experimental: Expansion Phase
Duvelisib administered in 28-day cycles (dose determined in Optimization Phase)
Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)
- Objective response rate (ORR) [ Time Frame: From start of treatment to first documented response, assessed up to 2 cycles (58 days) ]Best response of CR or PR
- Overall response rate (ORR) [ Time Frame: From start of treatment until disease progression or unacceptable toxicity, assessed up to 2 cycles (58 days) ]
- Number of participants with Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0 [ Time Frame: From start of treatment to end of treatment plus 30 days; 7 months ]
- Duration of Response (DOR) [ Time Frame: Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months ]
- Progression-free survival (PFS) [ Time Frame: Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months ]
- Disease control rate (DCR) [ Time Frame: Greater than or equal to 8 weeks ]
- Overall survival (OS) [ Time Frame: From start of treatment until death, 6 months ]
- Percentage of patients who receive the optimal dose of duvelisib [ Time Frame: From start of treatment to end of cycle 1 (each cycle is 28 days) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372057
|Contact: Jasminder Sotofirstname.lastname@example.org|
|Contact: Deborah Lloydemail@example.com|
|United States, California|
|City of Hope National Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Rosemarie Abary 626-218-8087 firstname.lastname@example.org|
|Principal Investigator: Jasmine Zain, MD|
|United States, Illinois|
|Northwestern University - Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Nick Cornicelli 312-695-0706 email@example.com|
|Principal Investigator: Barbara Pro, MD|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Erin Jeter 617-632-6218 Erin_Jeter@DFCI.HARVARD.EDU|
|Principal Investigator: Eric Jacobsen, MD|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Contact: Kristen McDaniels, BS 314-747-1207 firstname.lastname@example.org|
|Principal Investigator: Neha Mehta-Shah, MD|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Nasrin Ahmed 646-449-1311 email@example.com|
|Principal Investigator: Steven Horwitz, MD|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14627|
|Contact: Yelena Lerman 585-276-8333 firstname.lastname@example.org|
|Contact: Erin Cebula email@example.com|
|Principal Investigator: Carla Casulo, MD|
|United States, Ohio|
|The Ohio State Univeristy||Recruiting|
|Columbia, Ohio, United States, 43202|
|Contact: Pamela Heeter 614-293-9627 firstname.lastname@example.org|
|Principal Investigator: Jonathan Brammer, MD|
|Study Chair:||Hagop Youssoufian, MD||Verastem, Inc.|