N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT04803201

Registry updated: 2026-10-02
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Cyclophosphamide (Drug)
    Given IV
  • Doxorubicin (Drug)
    Given IV
  • Vincristine (Drug)
    Given IV
  • Prednisone (Drug)
    Given PO
  • Etoposide (Drug)
    Given IV or PO
  • Duvelisib (Drug)
    Given PO
  • Oral azacitidine (Drug)
    Given PO

Eligibility 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

Conditions

Angioimmunoblastic T-cell Lymphoma Enteropathy-Associated T-Cell Lymphoma Follicular T-Cell Lymphoma Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma Nodal Peripheral T-Cell Lymphoma With TFH Phenotype Peripheral T-Cell Lymphoma, Not Otherwise Specified

Locations

  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
  • City of Hope Comprehensive Cancer Center — Duarte, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
  • Grady Health System — Atlanta, Georgia, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
  • Augusta University Medical Center — Augusta, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • University of Illinois — Chicago, Illinois, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
  • Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
  • Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
  • AMG Libertyville - Oncology — Libertyville, Illinois, United States
  • Memorial Hospital East — Shiloh, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
  • Iowa Methodist Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
  • University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
  • University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
  • University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
  • Essentia Health Cancer Center — Duluth, Minnesota, United States
  • Mayo Clinic in Rochester — Rochester, Minnesota, United States
  • Saint Luke's Hospital — Chesterfield, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • Mercy Hospital Springfield — Springfield, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • Nebraska Medicine-Bellevue — Bellevue, Nebraska, United States
  • Nebraska Medicine-Village Pointe — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Cooper Hospital University Medical Center — Camden, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — Harrison, New York, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • NYP/Weill Cornell Medical Center — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • Wilmot Cancer Institute at Webster — Webster, New York, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Miami Valley Hospital South — Centerville, Ohio, United States
  • University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • Riverside Methodist Hospital — Columbus, Ohio, United States
  • Grant Medical Center — Columbus, Ohio, United States
  • Miami Valley Hospital — Dayton, Ohio, United States
  • Premier Blood and Cancer Center — Dayton, Ohio, United States
  • Dayton Physician LLC - Englewood — Dayton, Ohio, United States
  • Miami Valley Hospital North — Dayton, Ohio, United States
  • Delaware Health Center-Grady Cancer Center — Delaware, Ohio, United States
  • Atrium Medical Center-Middletown Regional Hospital — Franklin, Ohio, United States
  • Miami Valley Cancer Care and Infusion — Greenville, Ohio, United States
  • Greater Dayton Cancer Center — Kettering, Ohio, United States
  • Upper Valley Medical Center — Troy, Ohio, United States
  • University of Cincinnati Cancer Center-West Chester — West Chester, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • Dartmouth Cancer Center - North — Saint Johnsbury, Vermont, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • University of Washington Medical Center - Montlake — Seattle, Washington, United States
  • Providence Saint Mary Regional Cancer Center — Walla Walla, Washington, United States
  • Marshfield Medical Center-EC Cancer Center — Eau Claire, Wisconsin, United States
  • Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin, United States
  • University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
  • Marshfield Medical Center-Marshfield — Marshfield, Wisconsin, United States
  • Marshfield Medical Center - Minocqua — Minocqua, Wisconsin, United States
  • Marshfield Medical Center-Rice Lake — Rice Lake, Wisconsin, United States
  • Marshfield Medical Center-River Region at Stevens Point — Stevens Point, Wisconsin, United States
  • Marshfield Medical Center - Weston — Weston, Wisconsin, United States
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record