Recruiting
Phase 2

Duvelisib & CC-486

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT04803201

Conditions

Angioimmunoblastic T-cell Lymphoma

Enteropathy-Associated T-Cell Lymphoma

Follicular T-Cell Lymphoma

Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Doxorubicin

Vincristine

Prednisone

Etoposide

Study Details

Brief summary:

This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma.

Conditions

Angioimmunoblastic T-cell Lymphoma

Enteropathy-Associated T-Cell Lymphoma

Follicular T-Cell Lymphoma

Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma

Study ID

NCT04803201

Start date

Oct 8, 2021

Status verified date

Sep, 2026

Completion date

May 19, 2027

Anticipated

Primary completion date

May 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) with < 10% CD30 expression by immunohistochemistry in the following subtypes (by local review): nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (TFH-PTCL), follicular T-cell lymphoma, PTCL-not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma

  • Patients with expression of CD30 in >= 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted
  • Patients with a diagnosis of other PTCL subtype histologies other than those specified in the inclusion criteria are excluded including large cell transformation of mycosis fungoides
  • Patients will be stratified by presence or absence of TFH phenotype (i.e. diagnosis of AITL, TFH-PTCL, follicular T-cell lymphoma) based on local review of pathology. Determination of TFH phenotype can be defined by expression of two or more of the following markers CD10, BCL6, CXCL13, ICOS, and PD1 by immunohistochemistry
  • Measurable disease as defined by the Lugano criteria
  • No prior systemic therapy for lymphoma (excluding corticosteroids)
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to registration is required
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Platelet count >= 75,000/mm\^3 (>= 50,000/mm\^3 if secondary to bone marrow involvement from lymphoma per investigator assessment; the first 12 patients on each arm of the study must have platelets >= 75,000/mm\^3 regardless of bone marrow involvement)
  • Absolute neutrophil count (ANC) >= 1,000/mm\^3
  • Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 3.0 x upper limit of normal (ULN)

\* Except in subjects with documented liver involvement by lymphoma
  • Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula
  • Total bilirubin =< 2.0 x ULN

\* Except in cases of Gilbert's Syndrome or documented liver or pancreatic involvement by lymphoma
  • Archival tissue must be available for submission
  • Patients known to have HTLV 1/2 are excluded
  • Patients with known central nervous system involvement are excluded
  • No active viral infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Those who are seropositive (e.g. hepatitis B core antibody \[Ab\] positive) are permitted if they are negative by polymerase chain reaction (PCR). Those who are seropositive for hepatitis B and are negative for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) by PCR must receive concomitant hepatitis B directed antiviral therapy. Those who have hepatitis C Ab positivity who have completed curative therapy for hepatitis C with negative hepatitis C PCR are eligible
  • Patients with history of HIV are eligible if they have an undetectable viral load for at least 6 months
  • No active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment). Patients with Epstein-Barr virus (EBV) viremia related to their lymphoma are permitted
  • No concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapy for cancer previously treated for curative intent is permitted
  • Patients must have documented left ventricular ejection fraction of >= 45%
  • No significant active cardiac disease within the previous 6 months including:

  • New York Heart Association (NYHA) class III or IV congestive heart failure
  • Unstable angina or angina requiring surgical or medical intervention; and/or
  • Myocardial infarction
  • No contraindication to any drug in the chemotherapy regimen, including neuropathy >= grade 2
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (duvelisib, CHO[E]P)

Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive duvelisib PO BID on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

experimental: Arm B (CC-486, CHO[E]P)

Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive CC-486 PO QD on days -6 to 0 of cycle -1 and days 8-21 of cycles 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

active comparator: Arm C (CHO[E]P)

Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Interventions

Cyclophosphamide

Given IV

Doxorubicin

Given IV

Vincristine

Given IV

Prednisone

Given PO

Etoposide

Given IV or PO

Duvelisib

Given PO

Oral azacitidine

Given PO

Primary outcome measure

  • Complete remission (CR) rate [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Neha Mehta-Shah, MD, MSCI

314-747-7510mehta-n@wustl.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Site Public Contact

501-686-8274

Principal Investigator:

Mamatha Gaddam

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Akil A. Merchant

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jonathan H. Schatz

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jonathan H. Schatz

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Pamela B. Allen

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Pamela B. Allen

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Pamela B. Allen

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Pamela B. Allen

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Locke J. Bryan

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Jonathan Moreira

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Paul G. Rubinstein

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Jonathan Moreira

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Jonathan Moreira

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Jonathan Moreira

AMG Libertyville - Oncology

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Principal Investigator:

Peter J. Polewski

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Principal Investigator:

Neha Mehta-Shah

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Tanmay Sahai

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Jonathan Moreira

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Eric Mou

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Principal Investigator:

Marc S. Hoffmann

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Marc S. Hoffmann

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Chaitanya Iragavarapu

Our Lady of the Lake Physician Group

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Principal Investigator:

Nakhle S. Saba

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Kathryn Kline

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Eric D. Jacobsen

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Elie G. Dib

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Principal Investigator:

Bret E. Friday

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Nabila N. Bennani

Saint Luke's Hospital

Recruiting

Chesterfield, Missouri, United States, 63017

Contacts

Site Public Contact

314-205-6936

Principal Investigator:

Mark J. Fesler

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Principal Investigator:

Neha Mehta-Shah

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Neha Mehta-Shah

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Principal Investigator:

Neha Mehta-Shah

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Principal Investigator:

Neha Mehta-Shah

Nebraska Medicine-Bellevue

Recruiting

Bellevue, Nebraska, United States, 68123

Contacts

Principal Investigator:

Matthew A. Lunning

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Matthew A. Lunning

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Matthew A. Lunning

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Frederick Lansigan

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alison J. Moskowitz

Cooper Hospital University Medical Center

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Site Public Contact

856-325-6757

Principal Investigator:

Anil K. Rengan

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alison J. Moskowitz

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alison J. Moskowitz

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alison J. Moskowitz

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alison J. Moskowitz

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Jennifer E. Amengual

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alison J. Moskowitz

NYP/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-746-1848

Principal Investigator:

Jia Ruan

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Carla Casulo

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alison J. Moskowitz

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Principal Investigator:

Carla Casulo

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Anne W. Beaven

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Mary B. Seegars

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Principal Investigator:

Tarek M. Sabagh

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Tahir Latif

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Jonathan E. Brammer

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Principal Investigator:

Basem M. William

Grant Medical Center

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Principal Investigator:

Basem M. William

Miami Valley Hospital

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Principal Investigator:

Tarek M. Sabagh

Premier Blood and Cancer Center

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-276-8320

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital North

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Principal Investigator:

Tarek M. Sabagh

Delaware Health Center-Grady Cancer Center

Recruiting

Delaware, Ohio, United States, 43015

Contacts

Principal Investigator:

Basem M. William

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005-1066

Contacts

Principal Investigator:

Tarek M. Sabagh

Miami Valley Cancer Care and Infusion

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Site Public Contact

937-569-7515

Principal Investigator:

Tarek M. Sabagh

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Principal Investigator:

Tarek M. Sabagh

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Principal Investigator:

Tahir Latif

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Taha Al-Juhaishi

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Stefan K. Barta

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Brian T. Hess

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Harsh Shah

Dartmouth Cancer Center - North

Recruiting

Saint Johnsbury, Vermont, United States, 05819

Contacts

Principal Investigator:

Frederick Lansigan

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Nathan L. Roberts

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Ajay K. Gopal

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Ajay K. Gopal

Providence Saint Mary Regional Cancer Center

Recruiting

Walla Walla, Washington, United States, 99362

Contacts

Principal Investigator:

Alison K. Conlin

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Principal Investigator:

Chady A. Leon

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Principal Investigator:

Saurabh Rajguru

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Saurabh Rajguru

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Principal Investigator:

Chady A. Leon

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Principal Investigator:

Chady A. Leon

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Principal Investigator:

Chady A. Leon

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Principal Investigator:

Chady A. Leon

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Principal Investigator:

Chady A. Leon

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-09-02.