NCT00875056

Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103)

Completed Phase 2 Results posted Last updated 30 January 2026

What this trial tests

Phase 2 trial testing Vorinostat in Lymphoma in 56 participants. Completed in 8 February 2019.

Timeline

15 April 2009

Primary endpoint
6 September 2011

8 February 2019

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	15 April 2009
Primary completion	6 September 2011
Estimated completion	8 February 2019

Drugs / interventions tested

• Vorinostat (VORINOSTAT) — full drug profile →

Conditions studied

• Lymphoma — all drugs for Lymphoma →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 20 to 74, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate (ORR) Primary · Up to 650 days

ORR was defined as the percentage of participants who had a Complete Response (CR: Normal liver/spleen physical exam, all lymph nodes and nodal masses are normal, and there is no bone marrow involvement), a Complete Response/unconfirmed (CRu: Normal liver/spleen physical exam, plus at least a 75% decrease in the sum of the products of the greatest diameters of nodal masses if any are greater than 1.5 cm in their greatest diameter, normal or indeterminate bone marrow involvement), or a Partial Response (PR: Either normal physical exam, lymph nodes, and lymph node masses plus positive bone marro

Group	Value	95% CI
Follicular Lymphoma (FL)	48.7	32.4 – 65.2
Indolent Non-FL B-NHL or MCL	27.3	6.0 – 61.0

Number of Participants Who Experienced an Adverse Event (AE) Primary · Up to approximately 29 months

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE was presented.

Group	Value	95% CI
Follicular Lymphoma (FL)	39
Indolent Non-FL B-NHL or MCL	11
Other Disease	6

Time to Treatment Failure for Relapsed/Refractory FL Secondary · Up to 650 days

Time to Treatment Failure is defined as the time from allocation until the date of any treatment failure, including documented disease progression, or discontinuation of the study medication for any reason. Data was censored on the efficacy data cutoff date of 25 February, 2011.

Group	Value	95% CI
Follicular Lymphoma (FL)	323	60 – NA

Time to Response for Relapsed/Refractory FL Secondary · Up to 650 days

Time to Response is defined as the time from allocation until the time of an initial response. Data was censored on the efficacy data cutoff date of 25 February, 2011.

Group	Value	95% CI
Follicular Lymphoma (FL)	NA	NA – NA

Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) Primary · Up to 536 days

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued from study drug due to an adverse event was reported.

Group	Value	95% CI
Follicular Lymphoma (FL)	6
Indolent Non-FL B-NHL or MCL	1
Other Disease	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 65 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Follicular Lymphoma (FL)

Serious: 15/39 (38%)

Deaths: 9/39

Indolent Non-FL B-NHL or MCL

Serious: 4/11 (36%)

Deaths: 4/11

Other Disease

Serious: 2/6 (33%)

Deaths: 3/6

Serious adverse events (31 terms)

Reaction	System	Follicular Lymphoma (FL)	Indolent Non-FL B-NHL or MCL	Other Disease
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
H1N1 influenza	Infections and infestations	—	—	—
Meningitis aseptic	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Dizziness	Nervous system disorders	—	—	—
VIth nerve paralysis	Nervous system disorders	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—
Haemothorax	Respiratory, thoracic and mediastinal disorders	—	—	—
Deep vein thrombosis	Vascular disorders	—	—	—
Embolism venous	Vascular disorders	—	—	—
Bile duct stone	Hepatobiliary disorders	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—
Cystitis	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—
Parotitis	Infections and infestations	—	—	—
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Desmoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Other adverse events (129 terms — click to expand)

Reaction	System	Follicular Lymphoma (FL)	Indolent Non-FL B-NHL or MCL	Other Disease
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dysgeusia	Nervous system disorders	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Weight decreased	Investigations	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—
Blood creatinine increased	Investigations	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Nail disorder	Skin and subcutaneous tissue disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Hypercreatininaemia	Metabolism and nutrition disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Palpitations	Cardiac disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Chest pain	General disorders	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—
Hypermagnesaemia	Metabolism and nutrition disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Thrombocytopenia, Decreased appetite, Neutropenia, Abdominal pain, Asthenia, H1N1 influenza, Meningitis aseptic, Pneumonia.

Data from ClinicalTrials.gov NCT00875056 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat (MK-0683) in participants with relapsed and/or refractory follicular lymphoma. The exploratory purpose of this study is to evaluate efficacy of MK-0683 in participants with relapsed/refractory non-FL indolent B-NHL or relapsed/refractory MCL. The primary hypothesis is that MK-0683 will show efficacy in relapsed/refractory FL patients as measured by the Overall Response Rate.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Small Molecule NF-κB Pathway Inhibitors in Clinic.
   Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
2. A multicentre phase II study of vorinostat in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
   Ogura M, Ando K, Suzuki T, Ishizawa K, et al · · 2014 · cited 89× · PMID 24617454 · DOI 10.1111/bjh.12819
3. Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
   Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
4. Clinical epigenetics settings for cancer and cardiovascular diseases: real-life applications of network medicine at the bedside.
   Sarno F, Benincasa G, List M, Barabasi AL, et al · · 2021 · cited 49× · PMID 33785068 · DOI 10.1186/s13148-021-01047-z
5. Mantle cell lymphoma in the era of precision medicine-diagnosis, biomarkers and therapeutic agents.
   Inamdar AA, Goy A, Ayoub NM, Attia C, et al · · 2016 · cited 42× · PMID 27119356 · DOI 10.18632/oncotarget.8961
6. Follicular lymphoma, a B cell malignancy addicted to epigenetic mutations.
   Korfi K, Ali S, Heward JA, Fitzgibbon J. · · 2017 · cited 30× · PMID 28106467 · DOI 10.1080/15592294.2017.1282587
7. Current overview and treatment of mantle cell lymphoma.
   Schieber M, Gordon LI, Karmali R. · · 2018 · cited 28× · PMID 30109020 · DOI 10.12688/f1000research.14122.1
8. Recent Advances in the Targeting of Epigenetic Regulators in B-Cell Non-Hodgkin Lymphoma.
   Ribeiro ML, Reyes-Garau D, Armengol M, Fernández-Serrano M, et al · · 2019 · cited 20× · PMID 31681423 · DOI 10.3389/fgene.2019.00986