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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Sanjay Mohan
Study ID
NCT03955783
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 21, 2019
Status verified
Oct 2024
Primary completion
Sep 1, 2024
Completion
Sep 1, 2024

Study Design

Enrollment
78 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax, selinexor)
    Patients receive venetoclax PO QD on days 1-28. Patients with DLBCL receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Venetoclax naïve AML patients receive selinexor on days 8, 15, and 22 of cycle 1, followed by days 1, 8, 15, and 22 of subsequent cycles. Venetoclax refractory AML patients receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (escalation) [ Time Frame: Up to 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer CenterBuffaloNew York14263-
University Hospitals of ClevelandClevelandOhio44106-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75390-8565-

Find similar trials in Buffalo, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Roswell Park Cancer Center· Buffalo, NYUniversity Hospitals of Cleveland· Cleveland, OHVanderbilt-Ingram Cancer Center· Nashville, TNUniversity of Texas Southwestern Medical Center· Dallas, TX

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