New drug cocktail aims to boost lymphoma treatment

NCT ID NCT00972478

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This study tests adding vorinostat, a drug that blocks enzymes cancer cells need to grow, to the standard R-CHOP chemotherapy and antibody therapy for people with newly diagnosed advanced diffuse large B-cell lymphoma (DLBCL). The trial has two parts: first, finding the safest dose of vorinostat to use with R-CHOP, and second, seeing if this combination improves how long patients live without their cancer getting worse. About 83 participants with stage II bulky, III, or IV DLBCL are enrolled.

What this could mean

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

Active substance: vorinostat (SAHA) combined with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)
What this could lead to: If successful, this could lead to a more effective first-line treatment for advanced diffuse large B-cell lymphoma, potentially improving how long patients live without their cancer progressing.
What could go wrong: This is an early-phase trial (Phase I/II) with only 83 participants, so results may not apply to all patients. Adding vorinostat to standard chemotherapy could increase side effects, and the benefit over standard R-CHOP alone is not yet proven.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

83 people

The number who actually took part.

Started

Nov 2010

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * Patients must have biopsy proven, newly diagnosed DLBCL with stage II bulky, stage III or stage IV disease, with an International Prognostic Index (IPI) or revised (R)-IPI score greater than 0; a report providing confirmation of CD20 expression must be submitted * Adequate sections from the original diagnostic specimen must be available for submission for review by the Southwest Oncology Group (SWOG) Lymphoma Pathology Laboratory; an adequate biopsy requires sufficient tissue to establish the architecture and World Health Organization (WHO) histologic subtype with certainty; fine needle aspiration or cytology is not adequate * Patients must be offered the opportunity to consent to the correlative science studies; patients are encouraged to submit specimens for correlative studies; however, specimen submission is not a requirement for participation in the study * Patients must have measurable disease; measurable disease must be determined by computed tomography (CT) scan of chest, abdomen and pelvis performed within 28 days prior to registration; positron emission tomography (PET)/CT may be substituted for CT scan only if CT scan is of diagnostic quality and is contrast enhanced * Patients must have a unilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration * Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed within 42 days prior to registration to assess central nervous system (CNS) involvement must be negative * Patients must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma; steroid pre-medication for IV contrast allergy is allowed * Patients must have Zubrod performance status of 0-2 * Patients must have serum lactate dehydrogenase (LDH) measured within 28 days prior to registration * Absolute neutrophil count (ANC) \> 1,000/mcL within 28 days prior to registration, unless due to bone marrow infiltration by lymphoma * Platelets \> 100,000/mcL within 28 days prior to registration, unless due to bone marrow infiltration by lymphoma * Cardiac ejection fraction ≥ institutional lower limit of normal (ILLN) by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiogram (ECHO) with no significant abnormalities within 42 days prior to registration * Patients must not have received valproic acid (a histone deacetylase \[HDAC\] inhibitor) within 28 days prior to registration * Patients must have no known hypersensitivity to the components of treatment * Patients must be willing to discontinue taking any medications that are generally accepted to have a risk of causing Torsades de Pointes while on study * Patients known to be human immunodeficiency virus (HIV) positive are not eligible; existing therapeutic options are effective and study design does not support assessing the efficacy of treatment on those with HIV * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

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

Ann arbor stage II non-Hodgkin lymphoma Ann arbor stage III non-Hodgkin lymphoma Ann arbor stage IV non-Hodgkin lymphoma

Contacts and locations

Locations

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States
AdventHealth Hendersonville

Hendersonville, North Carolina, 28792, United States
AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States
AnMed Health Hospital

Anderson, South Carolina, 29621, United States
Arnot Ogden Medical Center/Falck Cancer Center

Elmira, New York, 14905, United States
Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States
Associates In Womens Health

Wichita, Kansas, 67208, United States
Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
Blanchard Valley Hospital

Findlay, Ohio, 45840, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Bronson Battle Creek

Battle Creek, Michigan, 49017, United States
Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States
Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States
Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States
Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States
Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States
Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States
Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States
Cancer Research for the Ozarks NCORP

Springfield, Missouri, 65804, United States
Castle Medical Center

Kailua, Hawaii, 96734, United States
Christus Saint Frances Cabrini Hospital

Alexandria, Louisiana, 71301, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Columbus NCI Community Oncology Research Program

Columbus, Ohio, 43215, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
Corewell Health Reed City Hospital

Reed City, Michigan, 49677, United States
Dayton NCI Community Oncology Research Program

Dayton, Ohio, 45459, United States
DeSoto Regional Health System

Mansfield, Louisiana, 71052, United States
Doctors Hospital

Columbus, Ohio, 43228, United States
Evergreen Hematology and Oncology PS

Spokane, Washington, 99218, United States
Fairfield Medical Center

Lancaster, Ohio, 43130, United States
Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States
Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, 46107, United States
Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States
Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701, United States
Glacier Oncology PLLC

Kalispell, Montana, 59901, United States
Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States
Grady Memorial Hospital

Delaware, Ohio, 43015, United States
Grandview Hospital

Dayton, Ohio, 45405, United States
Grant Medical Center

Columbus, Ohio, 43215, United States
Great Falls Clinic

Great Falls, Montana, 59405, United States
Greene Memorial Hospital

Xenia, Ohio, 45385, United States
Harborview Medical Center

Seattle, Washington, 98104, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, 98370, United States
Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, 96817, United States
HaysMed

Hays, Kansas, 67601, United States
Heartland Hematology and Oncology Associates Incorporated

Kansas City, Missouri, 64118, United States
Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States
Highland Clinic

Shreveport, Louisiana, 71105, United States
Highline Medical Center-Main Campus

Burien, Washington, 98166, United States
Hutchinson Regional Medical Center

Hutchinson, Kansas, 67502, United States
Interlakes Foundation Inc-Rochester

Rochester, New York, 14623, United States
Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States
Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States
Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States
Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States
Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819, United States
Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States
Kaiser Permanente San Leandro

San Leandro, California, 94577, United States
Kaiser Permanente Washington

Seattle, Washington, 98112, United States
Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States
Kaiser Permanente-Fremont

Fremont, California, 94538, United States
Kaiser Permanente-Fresno

Fresno, California, 93720, United States
Kaiser Permanente-Modesto

Modesto, California, 95356, United States
Kaiser Permanente-Oakland

Oakland, California, 94611, United States
Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States
Kaiser Permanente-Richmond

Richmond, California, 94801, United States
Kaiser Permanente-Roseville

Roseville, California, 95661, United States
Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States
Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States
Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States
Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States
Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States
Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton

Stockton, California, 95210, United States
Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States
Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, 66208, United States
Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
Knox Community Hospital

Mount Vernon, Ohio, 43050, United States
Kuakini Medical Center

Honolulu, Hawaii, 96817, United States
LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States
Lahey Clinic

Burlington, Massachusetts, 01805, United States
Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States
Liberty Hospital

Liberty, Missouri, 64068, United States
Licking Memorial Hospital

Newark, Ohio, 43055, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States
Marietta Memorial Hospital

Marietta, Ohio, 45750, United States
Mary Rutan Hospital

Bellefontaine, Ohio, 43311, United States
Memorial Health University Medical Center

Savannah, Georgia, 31404, United States
Menorah Medical Center

Overland Park, Kansas, 66209, United States
Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States
Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States
Mercy Hospital Pittsburg

Pittsburg, Kansas, 66762, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States
Miami Valley Hospital

Dayton, Ohio, 45409, United States
Miami Valley Hospital North

Dayton, Ohio, 45415, United States
Minor and James Medical PLLC

Seattle, Washington, 98104, United States
Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States
Montana Cancer Specialists

Missoula, Montana, 59802, United States
Mount Carmel Health Center West

Columbus, Ohio, 43222, United States
Munson Medical Center

Traverse City, Michigan, 49684, United States
NEA Baptist Memorial Hospital

Jonesboro, Arkansas, 72401, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States
North Kansas City Hospital

Kansas City, Missouri, 64116, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Ochsner LSU Health Monroe Medical Center

Monroe, Louisiana, 71202, United States
Overton Brooks Veteran's Administration Medical Center

Shreveport, Louisiana, 71101, United States
Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States
PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States
PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284, United States
Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States
Providence Hospital

Mobile, Alabama, 36608, United States
Providence Medical Center

Kansas City, Kansas, 66112, United States
Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States
Queen's Cancer Center - Pearlridge

‘Aiea, Hawaii, 96701, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Reid Health

Richmond, Indiana, 47374, United States
Research Medical Center

Kansas City, Missouri, 64132, United States
Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Rocky Mountain Oncology

Casper, Wyoming, 82609, United States
SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States
Saint Ann's Hospital

Westerville, Ohio, 43081, United States
Saint Charles Health System

Bend, Oregon, 97701, United States
Saint Francis Hospital

Greenville, South Carolina, 29601, United States
Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States
Saint Joseph Health Center

Kansas City, Missouri, 64114, United States
Saint Joseph Medical Center Hematology and Oncology - Silverdale

Silverdale, Washington, 98383, United States
Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States
Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
Saint Luke's South Hospital

Overland Park, Kansas, 66213, United States
Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States
Saint Peter's Community Hospital

Helena, Montana, 59601, United States
Saint Rose Ambulatory and Surgery Center

Great Bend, Kansas, 67530, United States
Saint Vincent Frontier Cancer Center

Billings, Montana, 59102, United States
Saint Vincent Healthcare

Billings, Montana, 59101, United States
Salina Regional Health Center

Salina, Kansas, 67401, United States
Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States
Southeast Clinical Oncology Research Consortium NCORP

Winston-Salem, North Carolina, 27104, United States
Southern Ohio Medical Center

Portsmouth, Ohio, 45662, United States
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, 49307, United States
Springfield Regional Medical Center

Springfield, Ohio, 45504, United States
Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States
Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States
Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States
Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
University Health Truman Medical Center

Kansas City, Missouri, 64108, United States
University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States
University of Rochester

Rochester, New York, 14642, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Upper Valley Medical Center

Troy, Ohio, 45373, United States
Wayne Hospital

Greenville, Ohio, 45331, United States
Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States
Welch Cancer Center

Sheridan, Wyoming, 82801, United States
Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States
Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States
Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, 96766, United States
Wright-Patterson Medical Center

Wright-Patterson Air Force Base, Ohio, 45433, United States
Yale University

New Haven, Connecticut, 06520, United States

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