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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | Alliance for Clinical Trials in Oncology Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin, prednisone |
| Locations | 96 sites (Little Rock, Arkansas and 95 other locations) |
| Status | Recruiting |
| Started | October 8, 2021 |
| Main results expected | May 19, 2027 |
| Study ends | May 19, 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT04803201 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
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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
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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
- Study coordinator: Neha Mehta-Shah, MD, MSCI
- Email: mehta-n@wustl.edu
- Phone: 314-747-7510
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.