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 CHO(E)P COMBINATION THERAPY

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 2

Enrollment: 170 patients (estimated)

View More

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arkansas

University of Arkansas for Medical Sciences (UAMS)

Little Rock, AR

Open and Accepting

California

Florida

Sylvester Comprehensive Cancer Center University of Miami

Deerfield Beach, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Emory University Winship Cancer Institute - Midtown

Atlanta, GA

Open and Accepting

Emory University Winship Cancer Institute - St. Joseph

Atlanta, GA

Open and Accepting

Illinois

Northwestern Medicine Cancer Center (Kishwaukee)

DeKalb, IL

Open and Accepting

Northwestern Medicine Cancer Center Delnor

Geneva, IL

Open and Accepting

Northwestern Medicine Lake Forest Hospital

Lake Forest, IL

Open and Accepting

Carle Cancer Institute

Urbana, IL

Open and Accepting

Northwestern Medicine Cancer Center Warrenville

Warrenville, IL

Open and Accepting

Iowa

Kansas

University of Kansas Cancer Center (Overland Park)

Overland Park, KS

Open and Accepting

University of Kansas Cancer Center (Westwood)

Westwood, KS

Open and Accepting

Michigan

IHA Hematology Oncology at St. Joe's Brighton

Brighton, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Missouri

St. Luke's Hospital

Chesterfield, MO

Open and Accepting

Siteman Cancer Center at Barnes-Jewish West County Hospital

Creve Coeur, MO

Open and Accepting

Siteman Cancer Center (South St. Louis County)

St. Louis, MO

Open and Accepting

Nebraska

Nebraska Medicine (Bellevue Medical Center)

Bellevue, NE

Open and Accepting

Nebraska Medicine (Village Pointe)

Omaha, NE

Open and Accepting

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Open and Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Open and Accepting

Ohio

OhioHealth Riverside Methodist Hospital

Columbus, OH

Open and Accepting

Miami Valley Hospital North Premier Health

Dayton, OH

Open and Accepting

Greater Dayton Cancer Center Dayton Physicians

Dayton, OH

Open and Accepting

Miami Valley Hospital

Dayton, OH

Open and Accepting

Premier Health Atrium Medical Center - Middletown

Middletown, OH

Open and Accepting

Premier Health Upper Valley Medical Center

Troy, OH

Open and Accepting

University of Cincinnati Medical Center - West Chester Hospital

West Chester Township, OH

Open and Accepting

Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, OK

Open and Accepting

Pennsylvania

Rhode Island

Lifespan Rhode Island Hospital

Providence, RI

Open and Accepting

South Carolina

Medical University of South Carolina

Charleston, SC

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Washington

Providence St. Mary Regional Cancer Center

Walla Walla, WA

Open and Accepting

Wisconsin

Marshfield Medical Center Cancer Center - Eau Claire

Eau Claire, WI

Open and Accepting

Gundersen Lutheran Medical Center

La Crosse, WI

Open and Accepting

Marshfield Medical Center - Hospital

Marshfield, WI

Open and Accepting

Marshfield Clinic (Minocqua Center)

Minocqua, WI

Open and Accepting

Marshfield Clinic (Rice Lake Center)

Rice Lake, WI

Open and Accepting

Marshfield Clinic Cancer Care (Saint Michael's Hospital)

Stevens Point, WI

Open and Accepting

Marshfield Medical Center St. Clare's Hospital

Weston, WI

Open and Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message