Trial · NCT02282358
Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
NCT02282358, Phase 1, Phase 2, Terminated, Memorial Sloan Kettering Cancer Center; results first posted 2024-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma. Trials, record NCT02282358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02282358
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Mocetinostat in Selected Patients With Mutations of Acetyltransferase Genes in Relapsed and Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
- NCT number
- NCT02282358
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Lymphoma, Relapsed and Refractory, Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
- Interventions
- Mocetinostat
- First posted
- 2014-11-04
- Last updated
- 2024-03-08
- Results first posted
- 2024-03-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy as Defined by Overall Response | 1 year | as defined by overall response rate of Mocetinostat at one year in patients with relapsed/refractory DLBCL and FL who have inactivating mutations of acetyltransferase genes. Response will be measured according to the 2007 revised Cheson criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in sum of the product of the diameters (SPD) of up to 6 dominant lesions identified at baseline; Overall Response (OR) = CR + PR. |
| Secondary | Event Free Survival | up to 17.8 months | defined as time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause) rate using mocetinostat in this selected population will be estimated by the Kaplan-Meier method. Relapsed disease/progressive disease is defined as at least 50% increase of target measurable nodal lesions |
| Secondary | Median Progression Free Survival/PFS | up to 17.8 months | is defined as the time from the date of first occurrence of CR or PR whichever is recorded first to the date of the first objectively documented progressive disease (PD) or death due to any cause. The duration of response will be assessed based on the sub-cohort of patients who showed responses also using Kaplan-Meier. |
| Secondary | Number of Participants Evaluated for Toxicity According to the (NCI CTCAE) Version 4.0. | 2 years | will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy as Defined by Overall Response | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Event Free Survival | up to 17.8 months | months | MEDIAN | |
| SECONDARY | Median Progression Free Survival/PFS | up to 17.8 months | months | MEDIAN | |
| SECONDARY | Number of Participants Evaluated for Toxicity According to the (NCI CTCAE) Version 4.0. | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy as Defined by Overall Response | Mocetinostat | Partial Response | 1 | Participants | |
| Efficacy as Defined by Overall Response | Mocetinostat | Stable Disease | 3 | Participants | |
| Efficacy as Defined by Overall Response | Mocetinostat | Progression of Disease | 2 | Participants | |
| Efficacy as Defined by Overall Response | Mocetinostat | Not Evaluable | 1 | Participants | |
| Event Free Survival | Mocetinostat | 4.6 | Full Range 0.3 to 17.8 | months | |
| Median Progression Free Survival/PFS | Mocetinostat | 4.6 | Full Range 1.4 to 13.1 | months | |
| Number of Participants Evaluated for Toxicity According to the (NCI CTCAE) Version 4.0. | Mocetinostat | 7 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mocetinostat | 7 | |
| Overall Study | COMPLETED | Mocetinostat | 6 | |
| Overall Study | NOT COMPLETED | Mocetinostat | 1 |
Source ClinicalTrials.gov
Adverse events31
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 | Diarrhea | Gastrointestinal disorders | Mocetinostat 90 mg | 5 | 7 | |
| other | Dyspepsia | Gastrointestinal disorders | Mocetinostat 90 mg | 3 | 7 | |
| other | Fatigue | General disorders | Mocetinostat 90 mg | 3 | 7 | |
| other | Nausea | Gastrointestinal disorders | Mocetinostat 90 mg | 3 | 7 | |
| other | Dizziness | Nervous system disorders | Mocetinostat 90 mg | 2 | 7 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | Mocetinostat 90 mg | 2 | 7 | |
| other | Alanine aminotransferase increased | Investigations | Mocetinostat 90 mg | 1 | 7 | |
| other | Alkaline phosphatase increased | Investigations | Mocetinostat 90 mg | 1 | 7 | |
| other | Aspartate aminotransferase increased | Investigations | Mocetinostat 90 mg | 1 | 7 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Mocetinostat 90 mg | 1 | 7 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mocetinostat 90 mg | 3 | 7 |
| Total, other adverse events | Mocetinostat 90 mg | 6 | 7 |
| Total, serious adverse events | Mocetinostat 90 mg | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02282358
GET https://conductscience.org/api/trials/v1/NCT02282358/events?page=2