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Testing new treatments 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

Phase 2 Interventional Alliance for Clinical Trials in Oncology · NCT04803201

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
Enrollment170 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy, cyclophosphamide, doxorubicin, prednisone
Locations80 sites (Little Rock, Arkansas and 79 other locations)
Trial IDNCT04803201 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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

Eligibility criteria

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 this trial is running

Little Rock, Arkansas and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Angioimmunoblastic T-cell LymphomaEnteropathy-Associated T-Cell LymphomaFollicular T-Cell LymphomaMature T-Cell and NK-Cell Non-Hodgkin LymphomaMonomorphic Epitheliotropic Intestinal T-Cell LymphomaNodal Peripheral T-Cell Lymphoma With TFH PhenotypePeripheral T-Cell Lymphoma, Not Otherwise Specified
Last reviewed 2026-06-15 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.