SUSPENDED

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

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Conditions

Angioimmunoblastic T-cell LymphomaEnteropathy-Associated T-Cell LymphomaFollicular T-Cell LymphomaMature T-Cell and NK-Cell Non-Hodgkin LymphomaMonomorphic Epitheliotropic Intestinal T-Cell LymphomaNodal Peripheral T-Cell Lymphoma With TFH PhenotypePeripheral T-Cell Lymphoma, Not Otherwise Specified

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2021-10-08
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04803201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  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)
  13. * Calculated creatinine clearance \>= 30 mL/min by Cockcroft-Gault formula
  14. * Total bilirubin =\< 2.0 x ULN
  15. * Archival tissue must be available for submission
  16. * Patients known to have HTLV 1/2 are excluded
  17. * Patients with known central nervous system involvement are excluded
  18. * 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
  19. * Patients with history of HIV are eligible if they have an undetectable viral load for at least 6 months
  20. * 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
  21. * 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
  22. * Patients must have documented left ventricular ejection fraction of \>= 45%
  23. * No significant active cardiac disease within the previous 6 months including:
  24. * New York Heart Association (NYHA) class III or IV congestive heart failure
  25. * Unstable angina or angina requiring surgical or medical intervention; and/or
  26. * Myocardial infarction
  27. * No contraindication to any drug in the chemotherapy regimen, including neuropathy \>= grade 2
  28. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Neha Mehta-Shah, MD, MSCI
STUDY_CHAIR
Washington University School of Medicine

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
Grady Health System
Atlanta, Georgia, 30303
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Illinois
Chicago, Illinois, 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
United States
Memorial Hospital East
Shiloh, Illinois, 62269
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Commack
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
NYP/Weill Cornell Medical Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Grant Medical Center
Columbus, Ohio, 43215
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409
United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
United States
Miami Valley Hospital North
Dayton, Ohio, 45415
United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409
United States
Upper Valley Medical Center
Troy, Ohio, 45373
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

  • Neha Mehta-Shah, MD, MSCI, STUDY_CHAIR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-08
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-10-08
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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