NCT00972478|Active Not RecruitingPhase 1Results

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)

National Cancer Institute (NCI)ClinicalTrials.gov

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5 other identifiers

NCI-2011-01964CDR0000653803S0806U10CA180888U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

190

Timeline

RegisteredSep 2009

StartedNov 2010

CompletionMar 2027

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

11mo left

Started Nov 2010

Longer than P75 for phase_1

Geographic Reach

1 country

190 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

16.3 years study duration

Study Progress95%

Nov 2010Mar 2027

First Submitted

Initial submission to the registry

September 4, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2009

Completed

1.2 years until next milestone

Study Start

First participant enrolled

November 15, 2010

Completed

5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed

10 months until next milestone

Results Posted

Study results publicly available

October 31, 2016

Completed

10.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2027

Expected

Last Updated

April 28, 2026

Status Verified

March 1, 2026

Enrollment Period

5.1 years

First QC Date

September 4, 2009

Results QC Date

September 8, 2016

Last Update Submit

April 9, 2026

Conditions

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

Outcome Measures

Primary Outcomes (2)

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).
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.
Up to 2 years

Secondary Outcomes (3)

Overall Survival (Phase II)
Up to 2 years
Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)
Up to week 26
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL
Up to week 26

Study Arms (1)

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.

Drug: CyclophosphamideDrug: Doxorubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: PrednisoneBiological: RituximabDrug: Vincristine SulfateDrug: Vorinostat

Interventions

CyclophosphamideDRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719