Angioimmunoblastic T-cell LymphomaPhase 2NCT04803201
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
A Phase 2 study testing Cyclophosphamide, Doxorubicin and Vincristine in people with Angioimmunoblastic T-cell Lymphoma and Enteropathy-Associated T-Cell Lymphoma, run by Alliance for Clinical Trials in Oncology at 96 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioimmunoblastic T-cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma, Follicular T-Cell Lymphoma
- What is being tested?
- Cyclophosphamide, Doxorubicin and Vincristine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 96 sitesUnited States
- Study dates
- 8 Oct 2021to 19 May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 30Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
96 sites in 1 country. Contact the study team or a site near you to ask about taking part.
96 sites in 1 country
United States96 sites, 84 recruiting
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Grady Health System
Atlanta, Georgia, 30303
Site Public Contact, 404-778-1868
Pamela B. Allen
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Pamela B. Allen
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Pamela B. Allen
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Pamela B. Allen
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
Site Public Contact, 706-721-2388, ga_cares@augusta.edu
Locke J. Bryan
- Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Public Contact, 800-888-8823
Kathryn Kline
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Alison J. Moskowitz
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Nakhle S. Saba
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Matthew A. Lunning
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Eric D. Jacobsen
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Active, not recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Site Public Contact, 856-325-6757
Anil K. Rengan
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Anne W. Beaven
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Brian T. Hess
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Nathan L. Roberts
- Recruiting
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Site Public Contact, 314-205-6936
Mark J. Fesler
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Jonathan Moreira
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Paul G. Rubinstein
- Completed
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
- Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Site Public Contact, 513-584-7698, cancer@uchealth.com
Tahir Latif
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Jonathan E. Brammer
- Recruiting
Riverside Methodist Hospital
Columbus, Ohio, 43214
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Basem M. William
- Recruiting
Grant Medical Center
Columbus, Ohio, 43215
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Basem M. William
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Alison J. Moskowitz
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Neha Mehta-Shah
- Recruiting
Miami Valley Hospital
Dayton, Ohio, 45409
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Suspended
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Site Public Contact, 305-243-2647
Jonathan H. Schatz
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jonathan Moreira
- Recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
Site Public Contact, 614-788-3860, Jennifer.Sexton@ohiohealth.com
Basem M. William
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Active, not recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jonathan Moreira
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Alison J. Moskowitz
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
Eric Mou
- Suspended
Greater Dayton Cancer Center
Kettering, Ohio, 45409
- Active, not recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
- Active, not recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Jonathan Moreira
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Frederick Lansigan
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Chaitanya Iragavarapu
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Peter J. Polewski
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Mamatha Gaddam
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Akil A. Merchant
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Saurabh Rajguru
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Saurabh Rajguru
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Site Public Contact, 305-243-2647
Jonathan H. Schatz
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
Alison J. Moskowitz
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
Alison J. Moskowitz
- Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Site Public Contact, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Jennifer E. Amengual
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
Alison J. Moskowitz
- Recruiting
NYP/Weill Cornell Medical Center
New York, New York, 10065
Site Public Contact, 212-746-1848
Jia Ruan
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Taha Al-Juhaishi
- Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Site Public Contact, 402-559-5600
Matthew A. Lunning
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Matthew A. Lunning
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Marc S. Hoffmann
- Recruiting
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Stefan K. Barta
- Suspended
Rhode Island Hospital
Providence, Rhode Island, 02903
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Nabila N. Bennani
- Recruiting
University of Rochester
Rochester, New York, 14642
Site Public Contact, 585-275-5830
Carla Casulo
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
Frederick Lansigan
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Harsh Shah
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Site Public Contact, 800-804-8824
Ajay K. Gopal
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
Site Public Contact, 800-804-8824
Ajay K. Gopal
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Neha Mehta-Shah
- Suspended
Mercy Hospital Springfield
Springfield, Missouri, 65804
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Neha Mehta-Shah
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Neha Mehta-Shah
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Neha Mehta-Shah
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Suspended
Upper Valley Medical Center
Troy, Ohio, 45373
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Site Public Contact, 212-639-7592
Alison J. Moskowitz
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Tanmay Sahai
- Suspended
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jonathan Moreira
- Active, not recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
- Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Wilmot Cancer Institute at Webster
Webster, New York, 14580
Site Public Contact, WCICTOresearch@urmc.rochester.edu
Carla Casulo
- Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Site Public Contact, 513-584-7698, cancer@uchealth.com
Tahir Latif
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Marc S. Hoffmann
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Mary B. Seegars
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the complete remission (CR) rates by positron emission tomography (PET)/computed tomography (CT) following completion of treatment with duvelisib-cyclophosphamide (C) doxorubicin (H) vincristine (O) (etoposide [E]) prednisone (P) versus (vs) CHO(E)P and with oral azacitidine (CC-486)-CHO(E)P vs CHO(E)P in previously untreated peripheral T-cell lymphomas that have < 10% expression of CD30.
SECONDARY OBJECTIVES:
- To determine the toxicity and tolerability of the treatment regimens. II. To determine the overall response rate (ORR), duration of response, progression free survival (PFS), event free survival (EFS), and overall survival (OS) of each treatment regimen.
III. To determine whether designation of follicular helper T-cell phenotype is correlated with response to therapy, PFS, EFS, and OS.
IV. To assess the toxicity profile of the experimental regimens in untreated CD30 negative peripheral T-cell lymphomas using Common Terminology Criteria for Adverse Events (CTCAE) and patient reported outcomes (PRO)-CTCAE.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A: Patients receive cyclophosphamide intravenously (IV) on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on days 1-3 or etoposide IV on day 1 and orally (PO) once daily (QD) on days 2-3 for patients <=60 years old, and prednisone PO QD on days 1-5. Patients also receive duvelisib PO twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on days 1-3 or etoposide IV on day 1 and orally (PO) once daily (QD) on days 2-3 for patients <=60 years old, and prednisone PO QD on days 1-5. Patients also receive CC-486 PO QD on days -6 to 0 of cycle -1 and days 8-21 of cycles 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on days 1-3 or etoposide IV on day 1 and orally (PO) once daily (QD) on days 2-3 for patients <=60 years old, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6 weeks after cycle 6 day 1, then every 12 weeks for 2 years, then every 24 weeks until 5 years from end of treatment or until documented progression of lymphoma. After documented progression of lymphoma, patients are followed up every 6 months until 5 years from end of 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
- Being tested
- Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Etoposide
- Medical subject headings
- Immunoblastic Lymphadenopathy, Enteropathy-Associated T-Cell Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Given IV
DoxorubicinDrug
Given IV
VincristineDrug
Given IV
PrednisoneDrug
Given PO
EtoposideDrug
Given IV or PO
DuvelisibDrug
Given PO
Oral azacitidineDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (duvelisib, CHO[E]P) | Experimental | Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive duvelisib PO BID on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Etoposide; Drug: Duvelisib |
| Arm B (CC-486, CHO[E]P) | Experimental | Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Patients also receive CC-486 PO QD on days -6 to 0 of cycle -1 and days 8-21 of cycles 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Etoposide; Drug: Oral azacitidine |
| Arm C (CHO[E]P) | Active comparator | Patients receive cyclophosphamide IV on day 1, doxorubicin IV on day 1, vincristine IV on day 1, etoposide IV on day 1 or days 1-3 or PO QD on days 2-3 for patients =< 60 years old, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate
Defined as the number of patients with complete remission (CR) divided by the total number of patients randomized. Will be measured by fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) at the completion of treatment (at end of treatment) and will be compared between each experimental arm and control arm. Final analyses will use z-scores obtained from a stratified Cochran-Mantel-Haenszel test to compare the CR rates between each experimental arm and control arm. For each treatment arm, CR rates will be estimated with their 95% confidence intervals.
Measured: Up to 6 months
Secondary outcomes (8)
Incidence of adverse events
Adverse events will be collected and graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. For CTCAE data, the maximum grade for each type of adverse will be recorded for each patient, and described using frequency tables. All-cause adverse events will be summarized as well as treatment-related adverse events.
Measured: Up to 5 years
Overall response rate (ORR)
Overall response includes complete and partial remissions by FDG PET/CT at the completion of treatment (at end of treatment). ORR will be estimated for each treatment arm and calculated as the number of patients with response divided by the total number of patients randomized. For each treatment arm, ORRs will be estimated with their 95% confidence intervals. ORR at the interim assessment will be summarized in the same manner, and how response changes between the interim and final assessment will be described.
Measured: Up to 6 months
Duration of response
The Kaplan-Meier method will be used to estimate duration of response for each treatment arm, with 2-year estimates and medians along with their 95% confidence intervals.
Measured: From first date of complete or partial remission until the earlier of disease progression, death from any cause, or non-protocol lymphoma-directed therapy to treat residual or progressive disease, assessed up to 5 years
Progression-free Survival (PFS)
The Kaplan-Meier method will be used to estimate PFS for each treatment arm, with 2-year PFS estimates and PFS medians along with their 95% confidence intervals.
Measured: From randomization date until the earlier of disease progression, death from any cause, or non-protocol lymphoma-directed therapy to treat residual or progressive disease, assessed up to 5 years
Event-free Survival (EFS)
The Kaplan-Meier method will be used to estimate event-free survival (EFS) for each treatment arm, with 2-year EFS estimates and EFS medians along with their 95% confidence intervals.
Measured: From randomization date until earlier of non-protocol lymphoma-directed therapy for any reason (excluding planned consolidative transplant), disease progression, or death from any cause, assessed up to 5 years
Overall Survival (OS)
The Kaplan-Meier method will be used to estimate overall survival (OS) for each treatment arm, with 2-year OS estimates and OS medians along with their 95% confidence intervals.
Measured: From randomization date until death from any cause, censoring patients alive at the date of last contact, assessed up to 5 years
Correlation of follicular helper T-cell phenotype with response, PFS, EFS and OS
CR rates and ORRs will be estimated with 95% confidence intervals for patients with and without the follicular helper T-cell phenotype, as well for patients with the peripheral T-cell lymphomas (PTCL) genotype.
Measured: Up to 5 years
Patient reported outcomes (PROs)
Patient reported outcomes (PROs) will be captured using the NCI PRO-CTCAE. Scores (0-4) and maximum score for each PRO-CTCAE item, with and without taking into account whether it is worse than the patient's own baseline score, will be recorded for each patient. PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start8 Oct 2021
- Primary completion19 May 2027 (estimated)
- Study completion19 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioimmunoblastic T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Neha Mehta-Shah, MD, MSCI, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803201
- Sponsor's protocol ID
- A051902
- Other IDs
- NCI-2021-01380, U10CA180821
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No