Taking people in United StatesPhase 2

Tests duvelisib or CC-486 added to usual chemotherapy for T-cell lymphoma

Tests adding duvelisib or CC-486 to standard chemotherapy in adults with peripheral T-cell lymphoma.

Plain-language title generated from the registry record
Registry title: Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma

Key facts

Where: Ankeny, Atlanta, Augusta, Baltimore, Basking Ridge, Baton Rouge, Bellevue, Boston, Brighton, Buffalo, Camden, Centerville, Chapel Hill, Charleston, Charlottesville, Chesterfield, Chicago, Cincinnati, Columbus, Commack, Creve Coeur, Dayton, Deerfield Beach, DeKalb, Delaware, Des Moines, Duarte, Duluth, Eau Claire, Franklin, Geneva, Greenville, Harrison, Iowa City, Kettering, La Crosse, La Jolla, Lake Forest, Lebanon, Lexington, Libertyville, Little Rock, Los Angeles, Madison, Marshfield, Miami, Middletown, Minocqua, Montvale, New York, Oklahoma City, Omaha, Overland Park, Philadelphia, Providence, Rice Lake, Rochester, Saint Johnsbury, Salt Lake City, Seattle, Shiloh, Springfield, St Louis, Stevens Point, Troy, Uniondale, Urbana, Walla Walla, Warrenville, Washington D.C., Waukee, Webster, West Chester, Weston, Westwood, and Winston-Salem, United StatesSee the 96 sites
Phase: Phase 2

Where in United States

UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
Emory Saint Joseph's HospitalAtlanta, United StatesTaking people
Emory University Hospital MidtownAtlanta, United StatesTaking people
Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesTaking people
Grady Health SystemAtlanta, United StatesTaking people
Augusta University Medical CenterAugusta, United StatesTaking people
University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesTaking people
Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesTaking people
Our Lady of the Lake Physician GroupBaton Rouge, United StatesTaking people
Nebraska Medicine-BellevueBellevue, United StatesTaking people
Dana-Farber Cancer InstituteBoston, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesNo longer taking part
Cooper Hospital University Medical CenterCamden, United StatesTaking people
Miami Valley Hospital SouthCenterville, United StatesTaking people
UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
Medical University of South CarolinaCharleston, United StatesTaking people
University of Virginia Cancer CenterCharlottesville, United StatesTaking people
Saint Luke's HospitalChesterfield, United StatesTaking people
Northwestern UniversityChicago, United StatesTaking people
University of IllinoisChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesNo longer taking part
University of Cincinnati Cancer Center-UC Medical CenterCincinnati, United StatesTaking people
Grant Medical CenterColumbus, United StatesTaking people
Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
Riverside Methodist HospitalColumbus, United StatesTaking people
Memorial Sloan Kettering CommackCommack, United StatesTaking people
Siteman Cancer Center at West County HospitalCreve Coeur, United StatesTaking people
Miami Valley HospitalDayton, United StatesTaking people
Miami Valley Hospital NorthDayton, United StatesTaking people
Premier Blood and Cancer CenterDayton, United StatesTaking people
Dayton Physician LLC - EnglewoodDayton, United StatesNo longer taking part
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United StatesTaking people
Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesTaking people
Delaware Health Center-Grady Cancer CenterDelaware, United StatesTaking people
Iowa Methodist Medical CenterDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
City of Hope Comprehensive Cancer CenterDuarte, United StatesNo longer taking part
Essentia Health Cancer CenterDuluth, United StatesTaking people
Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesTaking people
Atrium Medical Center-Middletown Regional HospitalFranklin, United StatesTaking people
Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
Miami Valley Cancer Care and InfusionGreenville, United StatesTaking people
Memorial Sloan Kettering WestchesterHarrison, United StatesTaking people
University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
Greater Dayton Cancer CenterKettering, United StatesNo longer taking part
Gundersen Lutheran Medical CenterLa Crosse, United StatesNo longer taking part
UC San Diego Moores Cancer CenterLa Jolla, United StatesNo longer taking part
Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesNo longer taking part
University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
AMG Libertyville - OncologyLibertyville, United StatesNo longer taking part
University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United StatesTaking people
University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
Memorial Sloan Kettering MonmouthMiddletown, United StatesTaking people
Marshfield Medical Center - MinocquaMinocqua, United StatesTaking people
Memorial Sloan Kettering BergenMontvale, United StatesTaking people
Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, United StatesTaking people
NYP/Weill Cornell Medical CenterNew York, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Nebraska Medicine-Village PointeOmaha, United StatesTaking people
University of Nebraska Medical CenterOmaha, United StatesTaking people
University of Kansas Cancer Center-Overland ParkOverland Park, United StatesTaking people
University of Pennsylvania/Abramson Cancer CenterPhiladelphia, United StatesTaking people
Rhode Island HospitalProvidence, United StatesNo longer taking part
Marshfield Medical Center-Rice LakeRice Lake, United StatesTaking people
Mayo Clinic in RochesterRochester, United StatesTaking people
University of RochesterRochester, United StatesTaking people
Dartmouth Cancer Center - NorthSaint Johnsbury, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
University of Washington Medical Center - MontlakeSeattle, United StatesTaking people
Memorial Hospital EastShiloh, United StatesTaking people
Mercy Hospital SpringfieldSpringfield, United StatesNo longer taking part
Siteman Cancer Center at Christian HospitalSt Louis, United StatesTaking people
Siteman Cancer Center-South CountySt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
Upper Valley Medical CenterTroy, United StatesTaking people
Memorial Sloan Kettering NassauUniondale, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Providence Saint Mary Regional Cancer CenterWalla Walla, United StatesTaking people
Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesTaking people
MedStar Georgetown University HospitalWashington D.C., United StatesNo longer taking part
UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
Wilmot Cancer Institute at WebsterWebster, United StatesTaking people
University of Cincinnati Cancer Center-West ChesterWest Chester, United StatesTaking people
Marshfield Medical Center - WestonWeston, United StatesTaking people
University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
Wake Forest University Health SciencesWinston-Salem, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

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Trial details

Who runs it: Alliance for Clinical Trials in Oncology
Trial code: NCT04803201
Record updated: 3 November 2026
Original description: 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.Read full original descriptionShow less
A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas
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.
Inclusion: 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.
ClinicalTrials.gov NCT04803201