Trial · 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)
NCT00875056, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2020-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT00875056. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00875056
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT00875056
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Lymphoma
- Interventions
- Vorinostat
- First posted
- 2009-04-03
- Last updated
- 2026-01-30
- Results first posted
- 2020-10-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 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 marrow involvement; OR normal physical exam or decrease in liver/spleen size plus at least a 50% decrease in the diameters of lymph nodes and nodal masses) as assessed using the international working group Non-Hodgkin's lymphoma standardized response criteria described by Cheson, BD in 1999. The percentage of participants who experienced a CR, CRu, or PR is presented. |
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | 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. |
| Primary | Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) | 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. |
| Secondary | Time to Treatment Failure for Relapsed/Refractory FL | 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. |
| Secondary | Time to Response for Relapsed/Refractory FL | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Up to 650 days | The analysis population included all allocated participants with follicular lymphoma (FL), non-FL B cell non-Hodgkin's lymphoma (B-NHL), or mantle cell lymphoma (MCL) who received at least one dose of study drug, and had some post-allocation endpoint data. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 29 months | All allocated participants who received a dose of study drug were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Treatment Failure for Relapsed/Refractory FL | Up to 650 days | The analysis population included all allocated participants with FL who received at least one dose of study drug, and had some post-allocation endpoint data. | Days | MEDIAN |
| SECONDARY | Time to Response for Relapsed/Refractory FL | Up to 650 days | The analysis population included all allocated participants with FL who received at least one dose of study drug, and had some post-allocation endpoint data. | Days | MEDIAN |
| PRIMARY | Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) | Up to 536 days | All allocated participants who received a dose of study drug were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Follicular Lymphoma (FL) | 48.7 | 95% Confidence Interval 32.4 to 65.2 | Percentage of participants | |
| Objective Response Rate (ORR) | Indolent Non-FL B-NHL or MCL | 27.3 | 95% Confidence Interval 6.0 to 61.0 | Percentage of participants | |
| Number of Participants Who Experienced an Adverse Event (AE) | Follicular Lymphoma (FL) | 39 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Indolent Non-FL B-NHL or MCL | 11 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Other Disease | 6 | Participants | ||
| Time to Treatment Failure for Relapsed/Refractory FL | Follicular Lymphoma (FL) | 323 | Full Range 60 to NA | Days | |
| Time to Response for Relapsed/Refractory FL | Follicular Lymphoma (FL) | NA | Full Range NA to NA | Days | |
| Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) | Follicular Lymphoma (FL) | 6 | Participants | ||
| Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) | Indolent Non-FL B-NHL or MCL | 1 | Participants | ||
| Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE) | Other Disease | 2 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Follicular Lymphoma (FL) | 39 | |
| Overall Study | STARTED | Indolent Non-FL B-NHL or MCL | 11 | |
| Overall Study | STARTED | Other Disease | 6 | |
| Overall Study | COMPLETED | Follicular Lymphoma (FL) | 5 | |
| Overall Study | COMPLETED | Indolent Non-FL B-NHL or MCL | 2 | |
| Overall Study | COMPLETED | Other Disease | 0 | |
| Overall Study | NOT COMPLETED | Follicular Lymphoma (FL) | 34 | |
| Overall Study | NOT COMPLETED | Indolent Non-FL B-NHL or MCL | 9 | |
| Overall Study | NOT COMPLETED | Other Disease | 6 |
Source ClinicalTrials.gov
Adverse events480
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Follicular Lymphoma (FL) | 12 | 39 | 25 |
| other | Anaemia | Blood and lymphatic system disorders | Indolent Non-FL B-NHL or MCL | 5 | 11 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Other Disease | 1 | 6 | 1 |
| other | Erythropenia | Blood and lymphatic system disorders | Follicular Lymphoma (FL) | 0 | 39 | 0 |
| other | Erythropenia | Blood and lymphatic system disorders | Indolent Non-FL B-NHL or MCL | 1 | 11 | 3 |
| other | Erythropenia | Blood and lymphatic system disorders | Other Disease | 0 | 6 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | Follicular Lymphoma (FL) | 20 | 39 | 107 |
| other | Leukopenia | Blood and lymphatic system disorders | Indolent Non-FL B-NHL or MCL | 8 | 11 | 45 |
| other | Leukopenia | Blood and lymphatic system disorders | Other Disease | 3 | 6 | 11 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Follicular Lymphoma (FL) | 1 | 39 | 1 |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Follicular Lymphoma (FL) | 9 | 39 |
| Total, all-cause mortality | Indolent Non-FL B-NHL or MCL | 4 | 11 |
| Total, all-cause mortality | Other Disease | 3 | 6 |
| Total, other adverse events | Follicular Lymphoma (FL) | 39 | 39 |
| Total, other adverse events | Indolent Non-FL B-NHL or MCL | 11 | 11 |
| Total, other adverse events | Other Disease | 6 | 6 |
| Total, serious adverse events | Follicular Lymphoma (FL) | 15 | 39 |
| Total, serious adverse events | Indolent Non-FL B-NHL or MCL | 4 | 11 |
| Total, serious adverse events | Other Disease | 2 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24617454 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00875056
GET https://conductscience.org/api/trials/v1/NCT00875056/events?page=2