A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:February 22, 2018
End Date:December 2021
Contact:Jasminder Soto
Email:jsoto@verastem.com
Phone:781-292-4250

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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)

This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual
inhibitor of PI3K-δ,γ, in patients with relapsed or refractory Peripheral T cell Lymphoma
(PTCL).

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.

Inclusion Criteria:

1. Age ≥ 18 years of age

2. Diagnosis of one of the following histologic subtypes of PTCL,
pathologically-confirmed, as defined by the World Health Organization:

1. Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS);

2. Angioimmunoblastic T-cell lymphomas (AITL);

3. Anaplastic large cell lymphoma (ALCL); or

4. Natural-killer/T-cell lymphoma (NKTL)

3. Received at least 2 cycles of one prior regimen administered with curative intent and
one of the following:

1. failed to achieve at least a partial response after 2 or more cycles;

2. failed to achieve a complete response after 6 or more cycles; and/or

3. progressed after an initial response

4. For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab
vedotin

5. Measurable disease as defined by IWG for PTCL, i.e., at least 1 measurable disease
lesion > 1.5 cm in at least one dimension by 18FDG-PET-CT, MRI, or diagnostic CT

Exclusion Criteria:

1. Clinical evidence of transformation to a more aggressive subtype of lymphoma

2. Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor

3. Known central nervous system involvement by PTCL

4. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic
steroids > 20 mg of prednisone (or equivalent) once daily (QD)

5. Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening
We found this trial at
7
sites
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Jasmine Zain, MD
Phone: 626-218-8087
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carla Casulo, MD
Phone: 585-276-8333
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Eric Jacobsen, MD
Phone: 617-632-6218
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Barbara Pro, MD
Phone: 312-695-0706
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Columbia, Ohio 43202
Principal Investigator: Jonathan Brammer, MD
Phone: 614-293-9627
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Columbia, OH
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Steven Horwitz, MD
Phone: 646-449-1311
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Saint Louis, Missouri 63110
Principal Investigator: Neha Mehta-Shah, MD
Phone: 314-747-1207
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Saint Louis, MO
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