Clinical trial Recruiting at 84 sites Phase 2 Interventional Ages 18 and up

Testing new treatments for peripheral T-cell lymphoma

Official title: 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

Run by Alliance for Clinical Trials in Oncology · NCT04803201 · Data updated 2026-11-12

This study is testing whether adding new drugs, duvelisib or CC-486, to standard chemotherapy can help people with peripheral T-cell lymphoma achieve better treatment results.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment170 (estimated)
SponsorAlliance for Clinical Trials in Oncology
Academic / other
Drugs / interventionschemotherapy, cyclophosphamide, doxorubicin, prednisone
Locations96 sites (Little Rock, Arkansas and 95 other locations)
StatusRecruiting
StartedOctober 8, 2021
Main results expectedMay 19, 2027
Study endsMay 19, 2027
Registry record updatedNovember 3, 2026
Trial IDNCT04803201 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with untreated peripheral T-cell lymphoma exhibiting less than 10% CD30 expression.

Probably not a fit

Patients with other subtypes of peripheral T-cell lymphoma or those with 10% or more CD30 expression may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of adding duvelisib or CC-486 to standard chemotherapy for patients with peripheral T-cell lymphoma. The study aims to compare complete remission rates using advanced imaging techniques after treatment with these new agents alongside traditional chemotherapy drugs. Participants will be randomized into different treatment arms to assess the safety, tolerability, and overall response rates of the new combinations. The trial also seeks to explore the correlation between specific T-cell phenotypes and treatment outcomes.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with peripheral T-cell lymphoma.

How similar studies have gone: Other studies have shown promise with similar treatment approaches, but this specific combination is being tested for the first time.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States
    Recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
    Deerfield Beach, Florida, United States
    Recruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida, United States
    Recruiting
  • Grady Health System
    Atlanta, Georgia, United States
    Recruiting
  • Emory University Hospital Midtown
    Atlanta, Georgia, United States
    Recruiting
Show 44 more locations
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia, United States
    Recruiting
  • Emory Saint Joseph's Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Augusta University Medical Center
    Augusta, Georgia, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois, United States
    Recruiting
  • University of Illinois
    Chicago, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee
    DeKalb, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois, United States
    Recruiting
  • Northwestern Medicine Lake Forest Hospital
    Lake Forest, Illinois, United States
    Recruiting
  • Memorial Hospital East
    Shiloh, Illinois, United States
    Recruiting
  • Carle Cancer Center
    Urbana, Illinois, United States
    Recruiting
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic
    Ankeny, Iowa, United States
    Recruiting
  • Iowa Methodist Medical Center
    Des Moines, Iowa, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    Des Moines, Iowa, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Laurel Clinic
    Des Moines, Iowa, United States
    Recruiting
  • University of Iowa/Holden Comprehensive Cancer Center
    Iowa City, Iowa, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Waukee Clinic
    Waukee, Iowa, United States
    Recruiting
  • University of Kansas Cancer Center-Overland Park
    Overland Park, Kansas, United States
    Recruiting
  • University of Kansas Hospital-Westwood Cancer Center
    Westwood, Kansas, United States
    Recruiting
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky, United States
    Recruiting
  • Our Lady of the Lake Physician Group
    Baton Rouge, Louisiana, United States
    Recruiting
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton
    Brighton, Michigan, United States
    Recruiting
  • Essentia Health Cancer Center
    Duluth, Minnesota, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting
  • Saint Luke's Hospital
    Chesterfield, Missouri, United States
    Recruiting
  • Siteman Cancer Center at West County Hospital
    Creve Coeur, Missouri, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
  • Siteman Cancer Center-South County
    St Louis, Missouri, United States
    Recruiting
  • Siteman Cancer Center at Christian Hospital
    St Louis, Missouri, United States
    Recruiting
  • Nebraska Medicine-Bellevue
    Bellevue, Nebraska, United States
    Recruiting
  • Nebraska Medicine-Village Pointe
    Omaha, Nebraska, United States
    Recruiting
  • University of Nebraska Medical Center
    Omaha, Nebraska, United States
    Recruiting
  • Memorial Sloan Kettering Basking Ridge
    Basking Ridge, New Jersey, United States
    Recruiting
  • Cooper Hospital University Medical Center
    Camden, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Monmouth
    Middletown, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Bergen
    Montvale, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Commack
    Commack, New York, United States
    Recruiting
  • Memorial Sloan Kettering Westchester
    Harrison, New York, United States
    Recruiting
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    New York, New York, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
  • NYP/Weill Cornell Medical Center
    New York, New York, United States
    Recruiting
  • University of Rochester
    Rochester, New York, United States
    Recruiting

+46 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Ruxolitinib with CHOP for untreated nodal TFH cell lymphoma

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.