CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 78 enrolled
Drug / intervention
Venetoclax +1 moredrug
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/NCT03955783
NCT03955783Phase 1Completed

An Investigator-Sponsored Phase Ib Trial of Venetoclax and SINE: Selective Inhibition of Nuclear Export in Patients with High Risk Hematologic Malignancies

Sanjay Mohan·interventional·Posted May 20, 2019·Updated Oct 26, 2024

In Brief

A Phase 1 clinical trial evaluating Venetoclax and Selinexor for Diffuse Large B-cell Lymphoma and 2 related conditions. Completed, enrolled 78 participants across 4 sites.

Detailed Summary

This phase Ib trial studies the toxicity and dosing of venetoclax in combination with selinexor, and how well the combination works in treatment of patients with high risk hematologic malignancies such as diffuse large B-cell lymphoma and acute myeloid leukemia that has come back (recurrent) or does not respond to initial treatment (refractory). Venetoclax functions by inhibiting a protein in the body called bcl-2, which is involved in slowing down the normal process by which old cells in the body are cleared (called apoptosis). Selinexor functions by trapping "tumor suppressing proteins" within the cell and causing the cancer cells to die or stop growing. This study examines the effects, if any, of selinexor and venetoclax on high risk hematologic malignancies and on the body, including any side-effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 20, 2019
Enrollment StartJun 21, 2019
Primary CompletionSep 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 7.1 years ago

Interventions

Venetoclaxdrug

Given by mouth

Selinexordrug

Given by mouth