OncRef

Clinical Trial: NCT03955783

Venetoclax and Selinexor in Treating Patients with Relapsed or Refractory High Risk Hematologic Malignancies

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Sanjay Mohan
Information Provided By:Vanderbilt-Ingram Cancer Center
Last Update Posted:2024-10-26

Study Overview

Brief 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.

Official Title

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

Conditions

Diffuse Large B-cell Lymphoma, Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma

Intervention / Treatment

  • Drug: Venetoclax
  • Drug: Selinexor

Other Study ID Numbers

  • VICC HEM 1755
  • NCI-2019-02953

Start Date (Actual)

2019-06-21

Primary Completion Date (Actual)

2024-09-01

Study Completion Date (Actual)

2024-09-01

Enrollment (Actual)

78

Study Type

Interventional

Phase

Phase 1