CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Mocetinostat Plus Brentuximab Vedotindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02429375
NCT02429375Phase 2Completed
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Phase IB/II Study of Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin Lymphoma

Memorial Sloan Kettering Cancer Center·interventional·Posted Apr 29, 2015·Updated May 12, 2022

In Brief

A Phase 2 clinical trial evaluating Mocetinostat Plus Brentuximab Vedotin for Hodgkin Lymphoma. Completed, enrolled 7 participants across 1 site.

Detailed Summary

The purpose of this study is to find out how safe and effective treatment with a new combination of drugs, mocetinostat and brentuximab vedotin, is in treating cancer. There will be 2 parts to this trial: a phase I part and a phase II part. Brentuximab vedotin is approved by the U.S. Food and Drug Administration (FDA) to be given to patients with Hodgkin Lymphoma. Mocetinostat is an experimental drug that has been given to patients with Hodgkin lymphoma in another clinical trial. When given alone, mocetinostat caused lymphoma to shrink in about 1 out of 4 patients with Hodgkin lymphoma. This is the first study that will give mocetinostat and brentuximab vedotin together.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHodgkin Lymphoma
CountriesUnited States
CollaboratorsMethylGene Inc.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 29, 2015
Enrollment StartApr 22, 2015
Primary CompletionFeb 17, 2021
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.2 years ago

Interventions

Mocetinostat Plus Brentuximab Vedotindrug

All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.