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
- Diseases
- Follicular lymphoma
- 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
Sites (96)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Coordinator of this site? Confirm its status | Ankeny | United States | Recruiting |
| Emory University Hospital/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory Saint Joseph's Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Our Lady of the Lake Physician Group Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
| Nebraska Medicine-Bellevue Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Coordinator of this site? Confirm its status | Brighton | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Active, not recruiting |
| Cooper Hospital University Medical Center Coordinator of this site? Confirm its status | Camden | United States | Recruiting |
| Miami Valley Hospital South Coordinator of this site? Confirm its status | Centerville | United States | Recruiting |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Saint Luke's Hospital Coordinator of this site? Confirm its status | Chesterfield | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Completed |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Cincinnati Cancer Center-UC Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Riverside Methodist Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Grant Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Siteman Cancer Center at West County Hospital Coordinator of this site? Confirm its status | Creve Coeur | United States | Recruiting |
| Miami Valley Hospital North Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Miami Valley Hospital Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| Dayton Physician LLC - Englewood Coordinator of this site? Confirm its status | Dayton | United States | Suspended |
| Premier Blood and Cancer Center Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Coordinator of this site? Confirm its status | Deerfield Beach | United States | Recruiting |
| Northwestern Medicine Cancer Center Kishwaukee Coordinator of this site? Confirm its status | DeKalb | United States | Recruiting |
| Delaware Health Center-Grady Cancer Center Coordinator of this site? Confirm its status | Delaware | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| Iowa Methodist Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Active, not recruiting |
| Essentia Health Cancer Center Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Recruiting |
| Atrium Medical Center-Middletown Regional Hospital Coordinator of this site? Confirm its status | Franklin | United States | Recruiting |
| Northwestern Medicine Cancer Center Delnor Coordinator of this site? Confirm its status | Geneva | United States | Recruiting |
| Miami Valley Cancer Care and Infusion Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Greater Dayton Cancer Center Coordinator of this site? Confirm its status | Kettering | United States | Suspended |
| Gundersen Lutheran Medical Center Coordinator of this site? Confirm its status | La Crosse | United States | Active, not recruiting |
| UC San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Active, not recruiting |
| Northwestern Medicine Lake Forest Hospital Coordinator of this site? Confirm its status | Lake Forest | United States | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Coordinator of this site? Confirm its status | Lebanon | United States | Suspended |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| AMG Libertyville - Oncology Coordinator of this site? Confirm its status | Libertyville | United States | Suspended |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Recruiting |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Marshfield Medical Center - Minocqua Coordinator of this site? Confirm its status | Minocqua | United States | Recruiting |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Nebraska Medicine-Village Pointe Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| University of Kansas Cancer Center-Overland Park Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Suspended |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Dartmouth Cancer Center - North Coordinator of this site? Confirm its status | Saint Johnsbury | United States | Recruiting |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Memorial Hospital East Coordinator of this site? Confirm its status | Shiloh | United States | Recruiting |
| Mercy Hospital Springfield Coordinator of this site? Confirm its status | Springfield | United States | Suspended |
| Marshfield Medical Center-River Region at Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Recruiting |
| Siteman Cancer Center at Christian Hospital Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Upper Valley Medical Center Coordinator of this site? Confirm its status | Troy | United States | Recruiting |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| Providence Saint Mary Regional Cancer Center Coordinator of this site? Confirm its status | Walla Walla | United States | Recruiting |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Recruiting |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Active, not recruiting |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Coordinator of this site? Confirm its status | Waukee | United States | Recruiting |
| Wilmot Cancer Institute at Webster Coordinator of this site? Confirm its status | Webster | United States | Recruiting |
| University of Cincinnati Cancer Center-West Chester Coordinator of this site? Confirm its status | West Chester | United States | Recruiting |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.