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NCT04898894 · ClinicalTrials.gov registry record · Phase 1
Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
A Phase 1 study of Refractory Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 8
- Study locations
NCT04898894 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 37 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (21% lower). The trial reports 8 study locations across 6 states.
The verdict
NCT04898894, a Phase 1 study of Refractory Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 8
- Study locations
Study Summary
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 deoxyribonucleic acid (DNA) (cfDNA). * Describe the quality of life of pediatric patients undergoing treatment with selinexor and venetoclax in combination with chemotherapy and explore associations of clinical factors with patient-reported quality of life outcomes. * Describe the clinical and genetic features associated with exceptional response to the combination of venetoclax and selinexor without the addition of chemotherapy.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Fludarabine
- DRUG Selinexor
- DRUG Cytarabine
- BIOLOGICAL Filgrastim
Study Locations (8)
Tennessee
- St. Jude Children's Research Hospital - Memphis
- Vanderbilt University Medical Center - Nashville
Texas
- UT Southwestern/Simmons Cancer Center - Dallas
- Cook Children's Medical Center - Fort Worth
California
- Rady Children's Hospital-San Diego - San Diego
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Memorial Sloan-Kettering Cancer Center - New York
Pennsylvania
- Childrens Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04898894
The ClinicalTrials.gov registry entry for NCT04898894 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (21% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT04898894 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Tennessee, Texas, California.
Frequently Asked Questions
What is clinical trial NCT04898894 about?
NCT04898894 is a clinical study titled "Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia". 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 d...
What is the current status of trial NCT04898894?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2021-11-15. Estimated completion is 2027-09.
What conditions does trial NCT04898894 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse, Refractory Acute Leukemia of Ambiguous Lineage, Acute Leukemia of Ambiguous Lineage in Relapse.
What interventions are being tested in trial NCT04898894?
The interventions under investigation include: Venetoclax (DRUG), Fludarabine (DRUG), Selinexor (DRUG), Cytarabine (DRUG), Filgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT04898894?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04898894 being conducted?
This trial has 8 study locations across California, Massachusetts, New York, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Refractory Acute Myeloid Leukemia
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.