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New drug cocktail aims to boost remission in tough lymphoma

NCT ID NCT04803201

Disease control Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 9 times

Summary

This phase II trial tests whether adding either duvelisib or oral azacitidine to standard chemotherapy improves outcomes for people with certain types of peripheral T-cell lymphoma that have not been treated yet. About 170 participants will receive one of three treatment combinations. The main goal is to see which approach leads to more complete remissions, while also monitoring side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Duvelisib, oral azacitidine (CC-486), cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone
What this could lead to
If successful, this could point toward a more effective first-line treatment for certain types of peripheral T-cell lymphoma, potentially improving remission rates.
What could go wrong
This is a phase II trial with only 170 participants, so results are preliminary. Adding new drugs to chemotherapy may increase side effects, and the study is currently suspended, which raises uncertainty.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

angioimmunoblastic T-cell lymphoma enteropathy-associated T-cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma monomorphic epitheliotropic intestinal T-cell lymphoma Nodal T-follicular helper cell lymphoma, follicular type peripheral T-cell lymphoma, not otherwise specified T-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    90 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMG Libertyville - Oncology

    RECRUITING

    Libertyville, Illinois, 60048, United States

    Contact Email: •••••@•••••

  • Atrium Medical Center-Middletown Regional Hospital

    RECRUITING

    Franklin, Ohio, 45005-1066, United States

    Contact Email: •••••@•••••

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • City of Hope Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Duarte, California, 91010, United States

  • Cooper Hospital University Medical Center

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dartmouth Cancer Center - North

    RECRUITING

    Saint Johnsbury, Vermont, 05819, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Dayton Physician LLC - Englewood

    SUSPENDED

    Dayton, Ohio, 45415, United States

  • Delaware Health Center-Grady Cancer Center

    RECRUITING

    Delaware, Ohio, 43015, United States

  • Emory Saint Joseph's Hospital

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Essentia Health Cancer Center

    RECRUITING

    Duluth, Minnesota, 55805, United States

    Contact Email: •••••@•••••

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Grady Health System

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Grant Medical Center

    RECRUITING

    Columbus, Ohio, 43215, United States

  • Greater Dayton Cancer Center

    SUSPENDED

    Kettering, Ohio, 45409, United States

  • Gundersen Lutheran Medical Center

    ACTIVE_NOT_RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Marshfield Medical Center - Minocqua

    RECRUITING

    Minocqua, Wisconsin, 54548, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center - Weston

    RECRUITING

    Weston, Wisconsin, 54476, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-EC Cancer Center

    RECRUITING

    Eau Claire, Wisconsin, 54701, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Marshfield

    RECRUITING

    Marshfield, Wisconsin, 54449, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-Rice Lake

    RECRUITING

    Rice Lake, Wisconsin, 54868, United States

    Contact Email: •••••@•••••

  • Marshfield Medical Center-River Region at Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54482, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    ACTIVE_NOT_RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hospital East

    RECRUITING

    Shiloh, Illinois, 62269, United States

  • Memorial Sloan Kettering Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    RECRUITING

    Harrison, New York, 10604, United States

  • Mercy Hospital Springfield

    SUSPENDED

    Springfield, Missouri, 65804, United States

  • Miami Valley Cancer Care and Infusion

    RECRUITING

    Greenville, Ohio, 45331, United States

  • Miami Valley Hospital

    RECRUITING

    Dayton, Ohio, 45409, United States

    Contact Email: •••••@•••••

  • Miami Valley Hospital North

    RECRUITING

    Dayton, Ohio, 45415, United States

    Contact Email: •••••@•••••

  • Miami Valley Hospital South

    RECRUITING

    Centerville, Ohio, 45459, United States

    Contact Email: •••••@•••••

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    RECRUITING

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • NYP/Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • Nebraska Medicine-Bellevue

    RECRUITING

    Bellevue, Nebraska, 68123, United States

  • Nebraska Medicine-Village Pointe

    RECRUITING

    Omaha, Nebraska, 68118, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Lake Forest Hospital

    RECRUITING

    Lake Forest, Illinois, 60045, United States

    Contact Email: •••••@•••••

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Our Lady of the Lake Physician Group

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

    Contact Email: •••••@•••••

  • Premier Blood and Cancer Center

    RECRUITING

    Dayton, Ohio, 45409, United States

  • Providence Saint Mary Regional Cancer Center

    RECRUITING

    Walla Walla, Washington, 99362, United States

  • Rhode Island Hospital

    SUSPENDED

    Providence, Rhode Island, 02903, United States

  • Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Roswell Park Cancer Institute

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14263, United States

  • Saint Luke's Hospital

    RECRUITING

    Chesterfield, Missouri, 63017, United States

  • Siteman Cancer Center at Christian Hospital

    RECRUITING

    St Louis, Missouri, 63136, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    RECRUITING

    Brighton, Michigan, 48114, United States

  • UC San Diego Moores Cancer Center

    ACTIVE_NOT_RECRUITING

    La Jolla, California, 92093, United States

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    RECRUITING

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    RECRUITING

    Waukee, Iowa, 50263, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • University of Arkansas for Medical Sciences

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Chicago Comprehensive Cancer Center

    COMPLETED

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-West Chester

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center-Overland Park

    RECRUITING

    Overland Park, Kansas, 66210, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Maryland/Greenebaum Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania/Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • University of Washington Medical Center - Montlake

    RECRUITING

    Seattle, Washington, 98195, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Upper Valley Medical Center

    RECRUITING

    Troy, Ohio, 45373, United States

    Contact Email: •••••@•••••

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Wilmot Cancer Institute at Webster

    RECRUITING

    Webster, New York, 14580, United States

    Contact Email: •••••@•••••

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