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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Ann Arbor Stage II Non-Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID: NCT00972478
Run by: National Cancer Institute (NCI)
People needed: 83
Starts: 2010-11-15
Expected to finish: 2027-03-06
Last updated by the study team: 2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
Banner University Medical Center - Tucson — Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
NEA Baptist Memorial Hospital — Jonesboro, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
Kaiser Permanente-Fremont — Fremont, California, United States
Kaiser Permanente-Fresno — Fresno, California, United States
USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
Kaiser Permanente-Modesto — Modesto, California, United States
Kaiser Permanente-Oakland — Oakland, California, United States
Kaiser Permanente-Redwood City — Redwood City, California, United States
Kaiser Permanente-Richmond — Richmond, California, United States
Kaiser Permanente-Roseville — Roseville, California, United States
Kaiser Permanente-South Sacramento — Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
Kaiser Permanente-San Francisco — San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose — San Jose, California, United States
Kaiser Permanente San Leandro — San Leandro, California, United States
Kaiser Permanente-San Rafael — San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States
Providence Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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