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NCT04803201RecruitingPhase 2

Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
170 (estimated)
First submitted
15 Mar 2021
Start date
8 Oct 2021
Primary completion date
19 May 2027
Lead sponsor
Alliance for Clinical Trials in Oncology
NCT number
NCT04803201

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 170
  • From 8 Oct 2021 to the primary completion date, 19 May 2027
  • 96 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (96)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Coordinator of this site? Confirm its status
AnkenyUnited StatesRecruiting
Emory University Hospital/Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Emory Saint Joseph's Hospital
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AtlantaUnited StatesRecruiting
Emory University Hospital Midtown
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AtlantaUnited StatesRecruiting
Grady Health System
Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
Augusta University Medical Center
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AugustaUnited StatesRecruiting
University of Maryland/Greenebaum Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Memorial Sloan Kettering Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesRecruiting
Our Lady of the Lake Physician Group
Coordinator of this site? Confirm its status
Baton RougeUnited StatesRecruiting
Nebraska Medicine-Bellevue
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BellevueUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Coordinator of this site? Confirm its status
BrightonUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesActive, not recruiting
Cooper Hospital University Medical Center
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CamdenUnited StatesRecruiting
Miami Valley Hospital South
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CentervilleUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
Saint Luke's Hospital
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ChesterfieldUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesCompleted
University of Illinois
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ChicagoUnited StatesRecruiting
University of Cincinnati Cancer Center-UC Medical Center
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CincinnatiUnited StatesRecruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
Riverside Methodist Hospital
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ColumbusUnited StatesRecruiting
Grant Medical Center
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ColumbusUnited StatesRecruiting
Memorial Sloan Kettering Commack
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CommackUnited StatesRecruiting
Siteman Cancer Center at West County Hospital
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Creve CoeurUnited StatesRecruiting
Miami Valley Hospital North
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DaytonUnited StatesRecruiting
Miami Valley Hospital
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DaytonUnited StatesRecruiting
Dayton Physician LLC - Englewood
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DaytonUnited StatesSuspended
Premier Blood and Cancer Center
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DaytonUnited StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Deerfield BeachUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
Delaware Health Center-Grady Cancer Center
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DelawareUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesRecruiting
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesRecruiting
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesActive, not recruiting
Essentia Health Cancer Center
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DuluthUnited StatesRecruiting
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesRecruiting
Atrium Medical Center-Middletown Regional Hospital
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FranklinUnited StatesRecruiting
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesRecruiting
Miami Valley Cancer Care and Infusion
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GreenvilleUnited StatesRecruiting
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
Greater Dayton Cancer Center
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KetteringUnited StatesSuspended
Gundersen Lutheran Medical Center
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La CrosseUnited StatesActive, not recruiting
UC San Diego Moores Cancer Center
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La JollaUnited StatesActive, not recruiting
Northwestern Medicine Lake Forest Hospital
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Lake ForestUnited StatesRecruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesSuspended
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesRecruiting
AMG Libertyville - Oncology
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LibertyvilleUnited StatesSuspended
University of Arkansas for Medical Sciences
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Little RockUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesRecruiting
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesRecruiting
Marshfield Medical Center - Minocqua
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MinocquaUnited StatesRecruiting
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesRecruiting
NYP/Weill Cornell Medical Center
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New YorkUnited StatesRecruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Nebraska Medicine-Village Pointe
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OmahaUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
University of Pennsylvania/Abramson Cancer Center
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PhiladelphiaUnited StatesRecruiting
Rhode Island Hospital
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ProvidenceUnited StatesSuspended
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesRecruiting
University of Rochester
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RochesterUnited StatesRecruiting
Mayo Clinic in Rochester
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RochesterUnited StatesRecruiting
Dartmouth Cancer Center - North
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Saint JohnsburyUnited StatesRecruiting
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesRecruiting
Fred Hutchinson Cancer Center
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SeattleUnited StatesRecruiting
University of Washington Medical Center - Montlake
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SeattleUnited StatesRecruiting
Memorial Hospital East
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ShilohUnited StatesRecruiting
Mercy Hospital Springfield
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SpringfieldUnited StatesSuspended
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesRecruiting
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Siteman Cancer Center-South County
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St LouisUnited StatesRecruiting
Upper Valley Medical Center
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TroyUnited StatesRecruiting
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Providence Saint Mary Regional Cancer Center
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Walla WallaUnited StatesRecruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
MedStar Georgetown University Hospital
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Washington D.C.United StatesActive, not recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesRecruiting
Wilmot Cancer Institute at Webster
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WebsterUnited StatesRecruiting
University of Cincinnati Cancer Center-West Chester
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West ChesterUnited StatesRecruiting
Marshfield Medical Center - Weston
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WestonUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Wake Forest University Health Sciences
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.