Ann Arbor Stage II Non-Hodgkin LymphomaPhase 1/2NCT00972478
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 1/2 study testing Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis in people with Ann Arbor Stage II Non-Hodgkin Lymphoma and Ann Arbor Stage III Non-Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 190 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ann Arbor Stage II Non-Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma
- What is being tested?
- Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 190 sitesUnited States
- Study dates
- 15 Nov 2010to 6 Mar 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
190 sites in 1 country.
190 sites in 1 country
United States190 sites
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, 96701
Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, 71301
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
AnMed Health Cancer Center
Anderson, South Carolina, 29621
AnMed Health Hospital
Anderson, South Carolina, 29621
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Bronson Battle Creek
Battle Creek, Michigan, 49017
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107
Mary Rutan Hospital
Bellefontaine, Ohio, 43311
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Saint Charles Health System
Bend, Oregon, 97701
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307
Billings Clinic Cancer Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Montana Cancer Consortium NCORP
Billings, Montana, 59102
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Boston Medical Center
Boston, Massachusetts, 02118
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Saint Anne Hospital
Burien, Washington, 98166
Lahey Clinic
Burlington, Massachusetts, 01805
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Rocky Mountain Oncology
Casper, Wyoming, 82609
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
Adena Regional Medical Center
Chillicothe, Ohio, 45601
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Riverside Methodist Hospital
Columbus, Ohio, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215
Grant Medical Center
Columbus, Ohio, 43215
Mount Carmel Health Center West
Columbus, Ohio, 43222
Doctors Hospital
Columbus, Ohio, 43228
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Miami Valley Hospital North
Dayton, Ohio, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459
Grady Memorial Hospital
Delaware, Ohio, 43015
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905
Blanchard Valley Hospital
Findlay, Ohio, 45840
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Kaiser Permanente-Fremont
Fremont, California, 94538
Kaiser Permanente-Fresno
Fresno, California, 93720
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, 67530
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Wayne Hospital
Greenville, Ohio, 45331
Saint Francis Hospital
Greenville, South Carolina, 29601
HaysMed
Hays, Kansas, 67601
Saint Peter's Community Hospital
Helena, Montana, 59601
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
Kuakini Medical Center
Honolulu, Hawaii, 96817
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401
Castle Medical Center
Kailua, Hawaii, 96734
Glacier Oncology PLLC
Kalispell, Montana, 59901
Logan Health Medical Center
Kalispell, Montana, 59901
Providence Medical Center
Kansas City, Kansas, 66112
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University Health Truman Medical Center
Kansas City, Missouri, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Saint Joseph Health Center
Kansas City, Missouri, 64114
North Kansas City Hospital
Kansas City, Missouri, 64116
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, 64118
Research Medical Center
Kansas City, Missouri, 64132
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Kettering Medical Center
Kettering, Ohio, 45429
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
Fairfield Medical Center
Lancaster, Ohio, 43130
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905
Liberty Hospital
Liberty, Missouri, 64068
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
DeSoto Regional Health System
Mansfield, Louisiana, 71052
Marietta Memorial Hospital
Marietta, Ohio, 45750
Loyola University Medical Center
Maywood, Illinois, 60153
Montana Cancer Specialists
Missoula, Montana, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Providence Hospital
Mobile, Alabama, 36608
Kaiser Permanente-Modesto
Modesto, California, 95356
Ochsner LSU Health Monroe Medical Center
Monroe, Louisiana, 71202
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Knox Community Hospital
Mount Vernon, Ohio, 43050
Skagit Valley Hospital
Mount Vernon, Washington, 98274
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Yale University
New Haven, Connecticut, 06520
Licking Memorial Hospital
Newark, Ohio, 43055
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
Kaiser Permanente-Oakland
Oakland, California, 94611
Menorah Medical Center
Overland Park, Kansas, 66209
Saint Luke's South Hospital
Overland Park, Kansas, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124
Kaiser Permanente-Redwood City
Redwood City, California, 94063
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Kaiser Permanente-Richmond
Richmond, California, 94801
Reid Health
Richmond, Indiana, 47374
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623
University of Rochester
Rochester, New York, 14642
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401
Kaiser Permanente-Roseville
Roseville, California, 95661
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
Cancer Center of Kansas - Salina
Salina, Kansas, 67401
Salina Regional Health Center
Salina, Kansas, 67401
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Kaiser Permanente San Leandro
San Leandro, California, 94577
Kaiser Permanente-San Rafael
San Rafael, California, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Memorial Health University Medical Center
Savannah, Georgia, 31404
Harborview Medical Center
Seattle, Washington, 98104
Minor and James Medical PLLC
Seattle, Washington, 98104
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Kaiser Permanente Washington
Seattle, Washington, 98112
Swedish Medical Center-First Hill
Seattle, Washington, 98122
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Welch Cancer Center
Sheridan, Wyoming, 82801
Overton Brooks Veteran's Administration Medical Center
Shreveport, Louisiana, 71101
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
Highland Clinic
Shreveport, Louisiana, 71105
Saint Joseph Medical Center Hematology and Oncology - Silverdale
Silverdale, Washington, 98383
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804
Mercy Hospital Springfield
Springfield, Missouri, 65804
Springfield Regional Medical Center
Springfield, Ohio, 45504
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Iredell Memorial Hospital
Statesville, North Carolina, 28677
Kaiser Permanente-Stockton
Stockton, California, 95210
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
Munson Medical Center
Traverse City, Michigan, 49684
Upper Valley Medical Center
Troy, Ohio, 45373
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
Saint Ann's Hospital
Westerville, Ohio, 43081
Associates In Womens Health
Wichita, Kansas, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina, 27104
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433
Greene Memorial Hospital
Xenia, Ohio, 45385
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701
About this study
Official title: 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)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Ann Arbor Stage II Non-Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma
- Being tested
- Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Prednisone, Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Given IV
Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given IV
RituximabBiological
Also called ABP 798, ABP-798, ABP798, BI 695500
Given IV
Also called Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin
Given IV
VorinostatDrug
Also called L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (combination chemotherapy) | Experimental | Patients receive vorinostat 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. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Prednisone; Biological: Rituximab; Drug: Vincristine Sulfate; Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 21 days
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.
Measured: Up to 2 years
Secondary outcomes (3)
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.
Measured: Up to 2 years
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.
Measured: Up to week 26
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.
Measured: Up to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study start15 Nov 2010
- Primary completion30 Dec 2015
- Study completion6 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ann Arbor Stage II Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel O Persky, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972478
- Sponsor's protocol ID
- NCI-2011-01964
- Other IDs
- NCI-2011-01964, CDR0000653803, S0806, S0806, U10CA180888, U10CA032102
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2009
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No