🔎 Trials Near Me

Home › Immunoblastic Lymphadenopathy › NCT04803201

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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Alliance for Clinical Trials in Oncology · Participants: 170 · Started: Oct 8, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04803201

Locations in the U.S.

ArkansasUniversity of Arkansas for Medical Sciences, Little Rock
CaliforniaCedars-Sinai Medical Center, Los Angeles
FloridaUM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami
GeorgiaEmory Saint Joseph's Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Emory University Hospital/Winship Cancer Institute, Atlanta
Grady Health System, Atlanta
Augusta University Medical Center, Augusta
IllinoisNorthwestern University, Chicago
University of Illinois, Chicago
Northwestern Medicine Cancer Center Kishwaukee, DeKalb
Northwestern Medicine Cancer Center Delnor, Geneva
Northwestern Medicine Lake Forest Hospital, Lake Forest
AMG Libertyville - Oncology, Libertyville
Memorial Hospital East, Shiloh
Carle Cancer Center, Urbana
Northwestern Medicine Cancer Center Warrenville, Warrenville
IowaUI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny
Iowa Methodist Medical Center, Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines
University of Iowa/Holden Comprehensive Cancer Center, Iowa City
UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee
KansasUniversity of Kansas Cancer Center-Overland Park, Overland Park
University of Kansas Hospital-Westwood Cancer Center, Westwood
KentuckyUniversity of Kentucky/Markey Cancer Center, Lexington
LouisianaOur Lady of the Lake Physician Group, Baton Rouge
MarylandUniversity of Maryland/Greenebaum Cancer Center, Baltimore
MassachusettsDana-Farber Cancer Institute, Boston
MichiganTrinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
MinnesotaEssentia Health Cancer Center, Duluth
Mayo Clinic in Rochester, Rochester
MissouriSaint Luke's Hospital, Chesterfield
Siteman Cancer Center at West County Hospital, Creve Coeur
Siteman Cancer Center at Christian Hospital, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
NebraskaNebraska Medicine-Bellevue, Bellevue
Nebraska Medicine-Village Pointe, Omaha
University of Nebraska Medical Center, Omaha
New HampshireDartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon
New JerseyMemorial Sloan Kettering Basking Ridge, Basking Ridge
Cooper Hospital University Medical Center, Camden
Memorial Sloan Kettering Monmouth, Middletown
Memorial Sloan Kettering Bergen, Montvale
New YorkMemorial Sloan Kettering Commack, Commack
Memorial Sloan Kettering Westchester, Harrison
Memorial Sloan Kettering Cancer Center, New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York
NYP/Weill Cornell Medical Center, New York
University of Rochester, Rochester
Memorial Sloan Kettering Nassau, Uniondale
Wilmot Cancer Institute at Webster, Webster
North CarolinaUNC Lineberger Comprehensive Cancer Center, Chapel Hill
Wake Forest University Health Sciences, Winston-Salem
OhioMiami Valley Hospital South, Centerville
University of Cincinnati Cancer Center-UC Medical Center, Cincinnati
Grant Medical Center, Columbus
Ohio State University Comprehensive Cancer Center, Columbus
Riverside Methodist Hospital, Columbus
Miami Valley Hospital, Dayton
Miami Valley Hospital North, Dayton
Premier Blood and Cancer Center, Dayton
Delaware Health Center-Grady Cancer Center, Delaware
Atrium Medical Center-Middletown Regional Hospital, Franklin
Miami Valley Cancer Care and Infusion, Greenville
Upper Valley Medical Center, Troy
University of Cincinnati Cancer Center-West Chester, West Chester
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
PennsylvaniaUniversity of Pennsylvania/Abramson Cancer Center, Philadelphia
South CarolinaMedical University of South Carolina, Charleston
UtahHuntsman Cancer Institute/University of Utah, Salt Lake City
VermontDartmouth Cancer Center - North, Saint Johnsbury
VirginiaUniversity of Virginia Cancer Center, Charlottesville
WashingtonFred Hutchinson Cancer Center, Seattle
University of Washington Medical Center - Montlake, Seattle
Providence Saint Mary Regional Cancer Center, Walla Walla
WisconsinMarshfield Medical Center-EC Cancer Center, Eau Claire
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison
University of Wisconsin Carbone Cancer Center - University Hospital, Madison
Marshfield Medical Center-Marshfield, Marshfield
Marshfield Medical Center - Minocqua, Minocqua
Marshfield Medical Center-Rice Lake, Rice Lake
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
Marshfield Medical Center - Weston, Weston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.