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NCT00972478Active, not recruitingPhase 1/2

Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination With Rituximab-CHOP in Patients With Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL)

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab and combination chemotherapy and to see how well it works in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large B-cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
83 (actual)
First submitted
4 Sept 2009
Start date
15 Nov 2010
Primary completion date
30 Dec 2015
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT00972478

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 83
  • From 15 Nov 2010 to the primary completion date, 30 Dec 2015
  • 190 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (190)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Pali Momi Medical Center
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‘AieaUnited StatesUnknown status
Queen's Cancer Center - Pearlridge
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‘AieaUnited StatesUnknown status
Christus Saint Frances Cabrini Hospital
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AlexandriaUnited StatesUnknown status
Cancer Care Center at Island Hospital
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AnacortesUnited StatesUnknown status
AnMed Health Cancer Center
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AndersonUnited StatesUnknown status
AnMed Health Hospital
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AndersonUnited StatesUnknown status
Kaiser Permanente-Deer Valley Medical Center
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AntiochUnited StatesUnknown status
Bronson Battle Creek
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Battle CreekUnited StatesUnknown status
Franciscan Saint Francis Health-Beech Grove
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Beech GroveUnited StatesUnknown status
Mary Rutan Hospital
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BellefontaineUnited StatesUnknown status
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesUnknown status
Saint Charles Health System
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BendUnited StatesUnknown status
Spectrum Health Big Rapids Hospital
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Big RapidsUnited StatesUnknown status
Saint Vincent Healthcare
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BillingsUnited StatesUnknown status
Montana Cancer Consortium NCORP
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BillingsUnited StatesUnknown status
Saint Vincent Frontier Cancer Center
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BillingsUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
Boston Medical Center
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BostonUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Saint Anne Hospital
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BurienUnited StatesUnknown status
Lahey Clinic
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BurlingtonUnited StatesUnknown status
Saint James Community Hospital and Cancer Treatment Center
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ButteUnited StatesUnknown status
Rocky Mountain Oncology
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CasperUnited StatesUnknown status
Cancer Center of Kansas - Chanute
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ChanuteUnited StatesUnknown status
Adena Regional Medical Center
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ChillicotheUnited StatesUnknown status
University of Cincinnati Cancer Center-UC Medical Center
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CincinnatiUnited StatesUnknown status
Riverside Methodist Hospital
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ColumbusUnited StatesUnknown status
Columbus NCI Community Oncology Research Program
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ColumbusUnited StatesUnknown status
Grant Medical Center
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ColumbusUnited StatesUnknown status
Doctors Hospital
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ColumbusUnited StatesUnknown status
Mount Carmel Health Center West
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ColumbusUnited StatesUnknown status
Grandview Hospital
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DaytonUnited StatesUnknown status
Good Samaritan Hospital - Dayton
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DaytonUnited StatesUnknown status
Miami Valley Hospital
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DaytonUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Dayton NCI Community Oncology Research Program
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DaytonUnited StatesUnknown status
Grady Memorial Hospital
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DelawareUnited StatesUnknown status
Cancer Center of Kansas - Dodge City
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Dodge CityUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesUnknown status
Cancer Center of Kansas - El Dorado
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El DoradoUnited StatesUnknown status
Arnot Ogden Medical Center/Falck Cancer Center
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ElmiraUnited StatesUnknown status
Blanchard Valley Hospital
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FindlayUnited StatesUnknown status
Poudre Valley Hospital
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Fort CollinsUnited StatesUnknown status
Cancer Center of Kansas - Fort Scott
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Fort ScottUnited StatesUnknown status
Mercy Hospital Fort Smith
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Fort SmithUnited StatesUnknown status
Atrium Medical Center-Middletown Regional Hospital
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FranklinUnited StatesUnknown status
Kaiser Permanente-Fremont
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FremontUnited StatesUnknown status
Kaiser Permanente-Fresno
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FresnoUnited StatesUnknown status
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesUnknown status
Wayne Memorial Hospital
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GoldsboroUnited StatesUnknown status
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesUnknown status
Cancer Research Consortium of West Michigan NCORP
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Grand RapidsUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesUnknown status
Saint Rose Ambulatory and Surgery Center
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Great BendUnited StatesUnknown status
Great Falls Clinic
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Great FallsUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Wayne Hospital
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GreenvilleUnited StatesUnknown status
Saint Francis Hospital
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GreenvilleUnited StatesUnknown status
HaysMed
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HaysUnited StatesUnknown status
Saint Peter's Community Hospital
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HelenaUnited StatesUnknown status
Margaret R Pardee Memorial Hospital
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HendersonvilleUnited StatesUnknown status
AdventHealth Hendersonville
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HendersonvilleUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
University of Hawaii Cancer Center
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HonoluluUnited StatesUnknown status
Straub Clinic and Hospital
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HonoluluUnited StatesUnknown status
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesUnknown status
Queen's Cancer Center - Kuakini
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HonoluluUnited StatesUnknown status
Queen's Medical Center
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HonoluluUnited StatesUnknown status
Tripler Army Medical Center
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HonoluluUnited StatesUnknown status
Hawaii Cancer Care Inc-Liliha
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HonoluluUnited StatesUnknown status
Kuakini Medical Center
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HonoluluUnited StatesUnknown status
Kaiser Permanente Moanalua Medical Center
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HonoluluUnited StatesUnknown status
Hutchinson Regional Medical Center
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HutchinsonUnited StatesUnknown status
Cancer Center of Kansas-Independence
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IndependenceUnited StatesUnknown status
Franciscan Health Indianapolis
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IndianapolisUnited StatesUnknown status
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesUnknown status
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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JonesboroUnited StatesUnknown status
NEA Baptist Memorial Hospital
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JonesboroUnited StatesUnknown status
Castle Medical Center
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KailuaUnited StatesUnknown status
Glacier Oncology PLLC
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KalispellUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Providence Medical Center
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Kansas CityUnited StatesUnknown status
Research Medical Center
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Kansas CityUnited StatesUnknown status
North Kansas City Hospital
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Kansas CityUnited StatesUnknown status
Saint Joseph Health Center
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Kansas CityUnited StatesUnknown status
University of Kansas Cancer Center
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Kansas CityUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
University Health Truman Medical Center
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Kansas CityUnited StatesUnknown status
Heartland Hematology and Oncology Associates Incorporated
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Kansas CityUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
Cancer Center of Kansas-Kingman
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KingmanUnited StatesUnknown status
Fairfield Medical Center
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LancasterUnited StatesUnknown status
Lawrence Memorial Hospital
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LawrenceUnited StatesUnknown status
Saint Luke's East - Lee's Summit
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Lee's SummitUnited StatesUnknown status
Cancer Center of Kansas-Liberal
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LiberalUnited StatesUnknown status
Liberty Hospital
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LibertyUnited StatesUnknown status
Wilcox Memorial Hospital and Kauai Medical Clinic
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LihueUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
DeSoto Regional Health System
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MansfieldUnited StatesUnknown status
Marietta Memorial Hospital
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MariettaUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesUnknown status
Montana Cancer Specialists
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MissoulaUnited StatesUnknown status
Providence Hospital
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MobileUnited StatesUnknown status
Kaiser Permanente-Modesto
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ModestoUnited StatesUnknown status
Ochsner LSU Health Monroe Medical Center
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MonroeUnited StatesUnknown status
Skagit Valley Hospital
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Mount VernonUnited StatesUnknown status
SSM Health Good Samaritan
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Mount VernonUnited StatesUnknown status
Knox Community Hospital
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Mount VernonUnited StatesUnknown status
Trinity Health Muskegon Hospital
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MuskegonUnited StatesUnknown status
Licking Memorial Hospital
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NewarkUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Cancer Center of Kansas - Newton
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NewtonUnited StatesUnknown status
Kaiser Permanente-Oakland
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OaklandUnited StatesUnknown status
Saint Luke's South Hospital
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Overland ParkUnited StatesUnknown status
Menorah Medical Center
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Overland ParkUnited StatesUnknown status
Cancer Center of Kansas - Parsons
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ParsonsUnited StatesUnknown status
Mercy Hospital Pittsburg
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PittsburgUnited StatesUnknown status
Southern Ohio Medical Center
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PortsmouthUnited StatesUnknown status
Harrison HealthPartners Hematology and Oncology-Poulsbo
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PoulsboUnited StatesUnknown status
Kansas City NCI Community Oncology Research Program
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Prairie VillageUnited StatesUnknown status
Cancer Center of Kansas - Pratt
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PrattUnited StatesUnknown status
Kaiser Permanente-Redwood City
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Redwood CityUnited StatesUnknown status
Corewell Health Reed City Hospital
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Reed CityUnited StatesUnknown status
Kaiser Permanente-Richmond
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RichmondUnited StatesUnknown status
Reid Health
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RichmondUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Interlakes Foundation Inc-Rochester
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RochesterUnited StatesUnknown status
Mercy Clinic-Rolla-Cancer and Hematology
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RollaUnited StatesUnknown status
Kaiser Permanente-Roseville
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RosevilleUnited StatesUnknown status
Kaiser Permanente-South Sacramento
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SacramentoUnited StatesUnknown status
Kaiser Permanente Sacramento Medical Center
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SacramentoUnited StatesUnknown status
Heartland Regional Medical Center
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Saint JosephUnited StatesUnknown status
Cancer Center of Kansas - Salina
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SalinaUnited StatesUnknown status
Salina Regional Health Center
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SalinaUnited StatesUnknown status
Kaiser Permanente-San Francisco
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San FranciscoUnited StatesUnknown status
Kaiser Permanente-Santa Teresa-San Jose
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San JoseUnited StatesUnknown status
Kaiser Permanente San Leandro
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San LeandroUnited StatesUnknown status
Kaiser Permanente-San Rafael
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San RafaelUnited StatesUnknown status
Kaiser Permanente Medical Center - Santa Clara
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Santa ClaraUnited StatesUnknown status
Kaiser Permanente-Santa Rosa
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Santa RosaUnited StatesUnknown status
Memorial Health University Medical Center
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SavannahUnited StatesUnknown status
Harborview Medical Center
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SeattleUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
Minor and James Medical PLLC
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SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Kaiser Permanente Washington
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SeattleUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesUnknown status
Welch Cancer Center
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SheridanUnited StatesUnknown status
Highland Clinic
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ShreveportUnited StatesUnknown status
Overton Brooks Veteran's Administration Medical Center
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ShreveportUnited StatesUnknown status
LSU Health Sciences Center at Shreveport
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ShreveportUnited StatesUnknown status
Saint Joseph Medical Center Hematology and Oncology - Silverdale
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SilverdaleUnited StatesUnknown status
Kaiser Permanente-South San Francisco
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South San FranciscoUnited StatesUnknown status
Spartanburg Medical Center
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SpartanburgUnited StatesUnknown status
Evergreen Hematology and Oncology PS
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SpokaneUnited StatesUnknown status
Cancer Care Northwest - Spokane South
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SpokaneUnited StatesUnknown status
Cancer Research for the Ozarks NCORP
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SpringfieldUnited StatesUnknown status
Mercy Hospital Springfield
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SpringfieldUnited StatesUnknown status
Springfield Regional Medical Center
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SpringfieldUnited StatesUnknown status
Iredell Memorial Hospital
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StatesvilleUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
Mercy Infusion Center - Chippewa
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St LouisUnited StatesUnknown status
Kaiser Permanente-Stockton
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StocktonUnited StatesUnknown status
University of Kansas Health System Saint Francis Campus
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TopekaUnited StatesUnknown status
Munson Medical Center
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Traverse CityUnited StatesUnknown status
Upper Valley Medical Center
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TroyUnited StatesUnknown status
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesUnknown status
University of Arizona Cancer Center-Orange Grove Campus
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TucsonUnited StatesUnknown status
Banner University Medical Center - Tucson
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TucsonUnited StatesUnknown status
Kaiser Permanente Medical Center-Vacaville
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VacavilleUnited StatesUnknown status
Kaiser Permanente-Vallejo
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VallejoUnited StatesUnknown status
Kaiser Permanente-Walnut Creek
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Walnut CreekUnited StatesUnknown status
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesUnknown status
Cancer Center of Kansas - Wellington
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WellingtonUnited StatesUnknown status
Wenatchee Valley Hospital and Clinics
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WenatcheeUnited StatesUnknown status
Saint Ann's Hospital
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WestervilleUnited StatesUnknown status
Cancer Center of Kansas - Wichita
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WichitaUnited StatesUnknown status
Wichita NCI Community Oncology Research Program
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WichitaUnited StatesUnknown status
Ascension Via Christi Hospitals Wichita
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WichitaUnited StatesUnknown status
Associates In Womens Health
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WichitaUnited StatesUnknown status
Cancer Center of Kansas-Wichita Medical Arts Tower
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WichitaUnited StatesUnknown status
Cancer Center of Kansas - Winfield
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WinfieldUnited StatesUnknown status
Southeast Clinical Oncology Research Consortium NCORP
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Winston-SalemUnited StatesUnknown status
Wright-Patterson Medical Center
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Wright-Patterson Air Force BaseUnited StatesUnknown status
Greene Memorial Hospital
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XeniaUnited StatesUnknown status
Genesis Healthcare System Cancer Care Center
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ZanesvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.