Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma (NCT04803201)

🧪 Interventions in This Study

• Cyclophosphamide (DRUG)
• Doxorubicin (DRUG)
• Vincristine (DRUG)
• Prednisone (DRUG)
• Etoposide (DRUG)
• Duvelisib (DRUG)
• Oral azacitidine (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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
2. Patients with expression of CD30 in \>= 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted
3. 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
4. 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
5. Measurable disease as defined by the Lugano criteria
6. No prior systemic therapy for lymphoma (excluding corticosteroids)
7. 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
8. Age \>= 18 years
9. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
10. 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)
11. Absolute neutrophil count (ANC) \>= 1,000/mm\^3
12. 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (96 Sites)

Showing the first 25 of 96 sites.

• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• City of Hope Comprehensive Cancer Center — Duarte, California
• UC San Diego Moores Cancer Center — La Jolla, California
• Cedars-Sinai Medical Center — Los Angeles, California
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
• Grady Health System — Atlanta, Georgia
• Emory University Hospital Midtown — Atlanta, Georgia
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• Emory Saint Joseph's Hospital — Atlanta, Georgia
• Augusta University Medical Center — Augusta, Georgia
• Northwestern University — Chicago, Illinois
• University of Illinois — Chicago, Illinois
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois
• Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois
• Northwestern Medicine Cancer Center Delnor — Geneva, Illinois
• Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois
• AMG Libertyville - Oncology — Libertyville, Illinois
• Memorial Hospital East — Shiloh, Illinois
• Carle Cancer Center — Urbana, Illinois
• Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois
• UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa
• Iowa Methodist Medical Center — Des Moines, Iowa
• UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa

📞 Contact the Study Coordinator

Phone: (314) 747-7510

Email: mehta-n@wustl.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Angioimmunoblastic T-cell Lymphoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.