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Antimetabolite

Selinexor + Venetoclax + Chemotherapy for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Jeffrey E. Rubnitz, MD, PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with prior HCT, no evidence of GVHD and a specific time interval must have elapsed
Participants must have a diagnosis of AML or ALAL and meet specific criteria related to refractory or relapsed leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up survival of each patient will be determined one year from enrollment.
Awards & highlights

Study Summary

This trial is testing the safety and 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).

Who is the study for?
This trial is for young patients aged 2-30 with Acute Myeloid Leukemia or ALAL that's resistant to treatment or has returned after therapy. They must have had at least two prior treatments, no severe heart, liver, kidney issues, and not be eligible for curative therapies like stem cell transplant due to disease severity.Check my eligibility
What is being tested?
The study tests the safety and best dose of venetoclax and selinexor combined with chemotherapy in children and young adults with relapsed/refractory AML/ALAL. It aims to find out how well this combination works for remission rates, survival time, leukemia cell response, quality of life impacts, and genetic factors influencing treatment success.See study design
What are the potential side effects?
Possible side effects include digestive problems affecting drug absorption; risks from uncontrolled infections; potential cerebellar toxicity (affecting balance/coordination); allergic reactions specific to venetoclax. Patients cannot participate if pregnant/breastfeeding without effective contraception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stem cell transplant and do not have GVHD.
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My leukemia has come back or is not responding to treatment.
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My leukemia shows more than 5% blasts in my bone marrow or blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~survival of each patient will be determined one year from enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and survival of each patient will be determined one year from enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients treated
Number of patients who experience a Hematologic DLT during the dose escalation phase
Number of patients who experience a Non-Hematologic dose limiting toxicity (DLT) during the dose escalation phase
+1 more
Secondary outcome measures
The overall survival of patients treated at the RP2D.
The rates of complete remission (CR) for patients treated with selinexor and venetoclax in combination with chemotherapy at the RP2D.
The rates of complete remission with incomplete count recovery (CRi) for patients treated with selinexor and venetoclax in combination with chemotherapy at the RP2D.
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment7 Interventions
Dose Escalation Phase: Venetoclax plus selinexor will initially be given at dose level 1 in combination with intravenous (IV) cytarabine and fludarabine. Dosing of venetoclax and selinexor will be based on tolerability. Intrathecal (IT) chemotherapy (IT cytarabine, IT methotrexate, and IT methotrexate/hydrocortisone/cytarabine (MHA) are all acceptable) will be given. G-CSF SC may be given. Part 1 has been completed and RP2D has been determined to be Dose Level 2. All participants will be treated at Dose Level 2. Dose Expansion Phase: Two expansion cohorts will be treated at the recommended phase 2 dose (RP2D). Cohort A will include venetoclax-naïve patients, whereas Cohort B will include patients with prior exposure to venetoclax.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2013
Completed Phase 4
~3800
Fludarabine
2012
Completed Phase 3
~1100
methotrexate/hydrocortisone/cytarabine
2014
Completed Phase 1
~20
Venetoclax
2019
Completed Phase 3
~1990
Selinexor
2020
Completed Phase 2
~1360
Cytarabine
2016
Completed Phase 3
~3310
Filgrastim
2000
Completed Phase 3
~3670

Find a Location

Who is running the clinical trial?

Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,528 Total Patients Enrolled
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,571 Total Patients Enrolled
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,537 Total Patients Enrolled

Media Library

Cytarabine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT04898894 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Treatment
Acute Myelogenous Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT04898894 — Phase 1
Cytarabine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04898894 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to join this medical trial at the present time?

"Affirmative. As per the records on clinicaltrials.gov, this medical experiment, which was originally published November 15th 2021 is still looking for participants. 42 individuals are required to be enrolled from 2 distinct sites."

Answered by AI

What overarching goals are the research teams aiming to achieve with this clinical test?

"The primary goal of this clinical trial, to be evaluated within 35 days of the initial chemotherapy dose, is the number of patients treated. Additionally, we are assessing exceptional response rates in Cohort A and B after day 15 with a specific definition for what constitutes an Exceptional Response (2 log reduction from bone marrow blast percentage at enrollment). Lastly, we are measuring response rate among those partaking in the Dose-escalation phase according to our predetermined criteria for an Exceptional Response."

Answered by AI

In what conditions is Venetoclax commonly prescribed?

"Venetoclax has been demonstrated to be an effective therapy for ulcerative colitis, myelosuppressive chemotherapy, and varicella-zoster virus acute retinal necrosis."

Answered by AI

How many participants have been enlisted in this research endeavor?

"Affirmative. The corresponding facts uploaded to clinicaltrials.gov reveal that this research initiative, first made available on November 15th 2021, is currently recruiting participants. 42 individuals from two distinct sites need to be enrolled."

Answered by AI

To what degree has Venetoclax been explored in past clinical investigations?

"Venetoclax was first investigated in 1995 at the NIH Clinical Center, with 1807 trials since completed. Currently 1054 clinical studies are actively recruiting participants, among which many are located in Memphis, Tennessee."

Answered by AI

Is Venetoclax sanctioned by the Federal Drug Administration?

"Based on the available evidence, Venetoclax's safety is estimated to be a 1 as it is currently in Phase 1 of clinical trials. This implies there are limited data supporting its efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
2021. "Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04898894.
~12 spots leftby Apr 2025
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