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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)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00972478
Enrollment
83
Registered
2009-09-07
Start date
2010-11-15
Completion date
2027-03-06
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage II Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma

Brief summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To find a safe dose of vorinostat to be used in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone) (vorinostat-R-CHOP). (Phase I) II. To estimate the 2-year progression-free survival (PFS) rate in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) treated with vorinostat and R-CHOP therapy (vorinostat-R-CHOP). (Phase II) III. To estimate the response rate (complete and partial) and 2-year overall survival rate. (Phase II) IV. To evaluate the toxicity of vorinostat-R-CHOP in patients with newly diagnosed DLBCL. (Phase II) V. To assess whether pre-treatment acetylation status of histones, expression of major histocompatibility complex (MHC) class II genes, and/or percentage of cluster of differentiation (CD)8+ tumor infiltrating lymphocytes correlate with progression-free survival. (Phase II) VI. To explore whether treatment with vorinostat-R-CHOP increases histone acetylation, alters expression of MHC class II proteins, or alters percentage of T-cell subsets (CD8+, CD4+, forkhead box P3 \[FOXP3\]+) or infiltrating macrophages. (Phase II) VII. To explore whether histone acetylation status of tumor tissues correlates with MHC class II expression of peripheral blood B cells and lymphocyte subsets. (Phase II) VIII. To explore whether the change in systemic levels of immune cytokines with vorinostat-R-CHOP correlates with lymphoma symptoms, response, progression-free or overall survival. (Phase II) OUTLINE: This is a phase I, dose escalation study of vorinostat followed by a phase II study. Patients receive vorinostat orally (PO) once daily on days 1-5 or 1-9 (according to dose level), rituximab intravenously (IV), cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years, and then annually for 3 years.

Interventions

DRUGCyclophosphamide

Given IV

DRUGDoxorubicin Hydrochloride

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGPrednisone

Given IV

BIOLOGICALRituximab

Given IV

DRUGVincristine Sulfate

Given IV

DRUGVorinostat

Given PO

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)21 daysSafe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
Progression-free Survival (Phase II)Up to 2 yearsFrom date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

Secondary

MeasureTime frameDescription
Overall Survival (Phase II)Up to 2 yearsFrom date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)Up to week 26Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLUp to week 26Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniel O Persky

SWOG Cancer Research Network

Participant flow

Participants by arm

ArmCount
Ph I: R-CHOP+Vorinostat (400mg D1-9)
Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
9
Ph II: R-CHOP+Vorinostat
Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
63
Total72

Baseline characteristics

CharacteristicPh I: R-CHOP+Vorinostat (400mg D1-9)Ph II: R-CHOP+VorinostatTotal
Age, Continuous66.9 years64.1 years64.2 years
Race/Ethnicity, Customized
Asian
0 participants5 participants5 participants
Race/Ethnicity, Customized
Black
0 participants3 participants3 participants
Race/Ethnicity, Customized
Hispanic
3 participants4 participants7 participants
Race/Ethnicity, Customized
Non-Hispanic
6 participants59 participants65 participants
Race/Ethnicity, Customized
Unknown
0 participants1 participants1 participants
Race/Ethnicity, Customized
White
9 participants54 participants63 participants
Sex: Female, Male
Female
3 Participants27 Participants30 Participants
Sex: Female, Male
Male
6 Participants36 Participants42 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
other
Total, other adverse events
9 / 963 / 63
serious
Total, serious adverse events
5 / 944 / 63

Outcome results

Primary

Progression-free Survival (Phase II)

From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

Time frame: Up to 2 years

Population: Eligible patients who received the protocol treatment in the Phase II portion of the study.

ArmMeasureValue (NUMBER)
Ph I: R-CHOP+Vorinostat (400mg D1-9)Progression-free Survival (Phase II)73 percentage of participants
Primary

Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)

Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).

Time frame: 21 days

Population: Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).

ArmMeasureValue (NUMBER)
Ph I: R-CHOP+Vorinostat (400mg D1-9)Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)400 mg PO Once daily Days 1-9
Secondary

Overall Survival (Phase II)

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Time frame: Up to 2 years

Population: Eligible patients who received the protocol treatment in the Phase II portion of the study.

ArmMeasureValue (NUMBER)
Ph I: R-CHOP+Vorinostat (400mg D1-9)Overall Survival (Phase II)86 percentage of participants
Secondary

Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)

Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

Time frame: Up to week 26

Population: Eligible patients who received the protocol treatment in the Phase II portion of the study

ArmMeasureValue (NUMBER)
Ph I: R-CHOP+Vorinostat (400mg D1-9)Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)81 percentage of participants
Secondary

Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL

Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

Time frame: Up to week 26

Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.

ArmMeasureGroupValue (NUMBER)
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypophosphatemia1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDisseminated intravascular coagulation1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypotension0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCD4 lymphocytes decreased0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLInfections and infestations - Other, specify1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDizziness1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLJejunal perforation0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAlanine aminotransferase increased0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLeft ventricular systolic dysfunction0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDuodenal perforation0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLeukocytosis0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCPK increased0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLung infection0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDysphagia0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLymphocyte count decreased4 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAspartate aminotransferase increased0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMucosal infection0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDyspnea0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMucositis oral1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCarbon monoxide diffusing capacity decreased0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMulti-organ failure1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLElectrocardiogram QT corrected interval prolonged1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMyalgia1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAbdominal pain1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMyocardial infarction0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLFatigue3 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLNausea1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLColitis1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLNeutrophil count decreased8 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLFebrile neutropenia3 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLObstruction gastric0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAtrial fibrillation0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPain0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLFecal incontinence0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLParonychia0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCreatinine increased1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPeripheral motor neuropathy1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLGastrointestinal disorders - Other, specify0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPlatelet count decreased4 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAnemia4 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPneumonitis0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLGeneralized muscle weakness2 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLRecurrent laryngeal nerve palsy0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCystitis noninfective0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLRespiratory failure0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHematuria1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLBladder spasm0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSinus tachycardia0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHiccups0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSinusitis0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDehydration2 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSmall intestinal obstruction0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHyperglycemia0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLStoma site infection0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAcute kidney injury0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSyncope0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypoalbuminemia1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLUrinary tract infection0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDepression1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLUrinary tract pain0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypocalcemia1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLUrine output decreased1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLBronchial infection0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLVasovagal reaction0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypokalemia2 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLVisceral arterial ischemia1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDiarrhea2 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLVomiting0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHyponatremia0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLWeight loss0 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAnorexia1 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLWhite blood cell decreased7 Participants
Ph I: R-CHOP+Vorinostat (400mg D1-9)Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSepsis3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLWhite blood cell decreased32 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAbdominal pain3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAcute kidney injury1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAlanine aminotransferase increased1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAnemia22 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAnorexia2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAspartate aminotransferase increased1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLAtrial fibrillation1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLBladder spasm1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLBronchial infection1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCD4 lymphocytes decreased1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCPK increased1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCarbon monoxide diffusing capacity decreased1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLColitis0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCreatinine increased0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLCystitis noninfective1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDehydration4 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDepression0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDiarrhea2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDisseminated intravascular coagulation0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDizziness0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDuodenal perforation1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDysphagia1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLDyspnea1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLElectrocardiogram QT corrected interval prolonged1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLFatigue9 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLFebrile neutropenia24 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLFecal incontinence1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLGastrointestinal disorders - Other, specify1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLGeneralized muscle weakness2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHematuria0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHiccups1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHyperglycemia4 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypoalbuminemia3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypocalcemia0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypokalemia8 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHyponatremia6 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypophosphatemia2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLHypotension3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLInfections and infestations - Other, specify3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLJejunal perforation1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLeft ventricular systolic dysfunction1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLeukocytosis1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLung infection4 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLLymphocyte count decreased20 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMucosal infection1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMucositis oral3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMulti-organ failure0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMyalgia2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLMyocardial infarction2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLNausea3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLNeutrophil count decreased37 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLObstruction gastric1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPain1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLParonychia1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPeripheral motor neuropathy0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPlatelet count decreased22 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLPneumonitis1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLRecurrent laryngeal nerve palsy1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLRespiratory failure1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSepsis11 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSinus tachycardia1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSinusitis1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSmall intestinal obstruction1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLStoma site infection1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLSyncope4 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLUrinary tract infection3 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLUrinary tract pain2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLUrine output decreased0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLVasovagal reaction1 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLVisceral arterial ischemia0 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLVomiting2 Participants
Ph II: R-CHOP+VorinostatToxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCLWeight loss3 Participants

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026