Phase 1Active, not recruiting
Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
A Phase I and Expansion Cohort Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
- Sponsor
- St. Jude Children's Research Hospital (Academic or other)
- Enrolment
- 37 enrolled
- Conditions
- Acute Leukemia of Ambiguous Lineage in Relapse; Acute Myeloid Leukemia, in Relapse; Refractory Acute Leukemia of Ambiguous Lineage; Refractory Acute Myeloid Leukemia
- Interventions
- Venetoclax; Selinexor; Cytarabine; Fludarabine; Filgrastim; Methotrexate; methotrexate/hydrocortisone/cytarabine
- Ages
- children, adults
- Registry
- NCT04898894
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to test the safety and determine the best dose of venetoclax and selinexor when given with chemotherapy drugs in treating pediatric and young adult patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that has come back (relapsed) or did not respond to treatment (refractory). Primary Objective * To determine the safety and tolerability of selinexor and venetoclax in combination with chemotherapy in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives * Describe the rates of complete remission (CR) and complete remission with incomplete count recovery (CRi) for patients treated with selinexor and venetoclax in combination with chemotherapy at the recommended phase 2 dose (RP2D). * Describe the overall survival of patients treated at the RP2D. Exploratory Objectives * Explore associations between leukemia cell genomics, BCL2 family member protein quantification, BH3 profiling, and response to therapy as assessed by minimal residual disease (MRD) and variant clearance using cell-free…
Primary outcomes
- The recommended phase 2 dose (RP2D) of venetoclax plus selinexor plus chemotherapy.
- Number of patients treated
- Number of patients who experience a Non-Hematologic dose limiting toxicity (DLT) during the dose escalation phase
- Number of patients who experience a Hematologic DLT during the dose escalation phase
History
Study completion expected
Last registry update
Primary completion
Started
Registered