NCT04898894 - Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 15, 2021

Primary Completion Date

July 12, 2023

Study Completion Date

February 28, 2026

Conditions

Acute Leukemia of Ambiguous Lineage in RelapseAcute Myeloid Leukemia, in RelapseRefractory Acute Leukemia of Ambiguous LineageRefractory Acute Myeloid Leukemia

Interventions

DRUG

Venetoclax

Given orally (PO)

DRUG

Selinexor

Given Orally (PO)

DRUG

Cytarabine

Given in to the vein (IV) or intrathecal (IT)

DRUG

Fludarabine

Given in to the vein (IV) - Because of the ongoing nationwide shortage of fludarabine, this agent may be omitted during the dose expansion phase of the trial.

BIOLOGICAL

Filgrastim

Given subcutaneous (SubQ, SC)

DRUG

Methotrexate

Given intrathecal (IT)

DRUG

methotrexate/hydrocortisone/cytarabine

Given intrathecal (IT)

Trial Locations (8)

10065

Memorial Sloan-Kettering Cancer Center, New York

19104

Childrens Hospital of Philadelphia, Philadelphia

37232

Vanderbilt University Medical Center, Nashville

38105

St. Jude Children's Research Hospital, Memphis

75390

UT Southwestern/Simmons Cancer Center, Dallas

76104

Cook Children's Medical Center, Fort Worth

92123

Rady Children's Hospital-San Diego, San Diego

02215

Dana-Farber Cancer Institute, Boston