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Small Molecule

KPT-9274 for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Daniel Pollyea, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with WHO-confirmed non-APL AML who have not responded to or relapsed after at least one prior therapy and for whom no standard therapy that may provide clinical benefit is available
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will study a new drug to treat patients with a certain type of leukemia that has returned or does not respond to other treatments.

Who is the study for?
Adults with acute myeloid leukemia that's come back or hasn't responded to treatment, and no other beneficial therapy is available. They must be able to perform daily activities with some limitations (ECOG ≤ 2), have good liver and kidney function, not be pregnant or breastfeeding, agree to use contraception, and not have had cancer treatment in the last 2 weeks.Check my eligibility
What is being tested?
The trial tests KPT-9274 taken orally for safety and effectiveness in patients with relapsed or refractory acute myeloid leukemia. It aims to see how well patients tolerate this drug as a potential new treatment option.See study design
What are the potential side effects?
While specific side effects of KPT-9274 are not listed here, common ones for leukemia treatments include nausea, fatigue, risk of infection due to low blood cell counts, bleeding issues from low platelets, liver problems indicated by changes in enzymes levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My AML has not improved or has returned after treatment, and no standard treatments are likely to help.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Establish Recommended Phase 2 Dose (RP2D)

Trial Design

6Treatment groups
Active Control
Group I: Cohort 5; 100mgActive Control1 Intervention
Dose escalation to 100 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
Group II: De-escalation Cohort; 20mgActive Control1 Intervention
For the purposes of dose escalation decisions, a standard 3+3 dose escalation design will be used.The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg. If the MTD is exceeded at cohort 1, de-escalation to cohort 0 (20 mg) will occur. If the MTD is not exceeded in cohort 1, dose escalation will continue based on a standard 3+3 design at the dose levels.
Group III: Cohort 1; 30 mgActive Control1 Intervention
The initial cohort, Cohort 1, will consist of 3 enrolled patients who will be treated at 30 mg.
Group IV: Cohort 2; 40mgActive Control1 Intervention
Dose escalation to 40 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
Group V: Cohort 3; 60mgActive Control1 Intervention
Dose escalation to 60 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.
Group VI: Cohort 4; 80mgActive Control1 Intervention
Dose escalation to 80 mg after initial cohort (Cohort 1) after a minimum of 1 cycle of treatment, defined as receiving ≥75% of KPT-9274 doses during Cycle 1 (e.g., ≥9 of 12 doses in the 3 doses/week schedule), or have a DLT within the first cycle of treatment to be evaluable for dose escalation decisions.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,338 Total Patients Enrolled
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,539 Total Patients Enrolled
Daniel Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
107 Total Patients Enrolled

Media Library

KPT-9274 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04914845 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Cohort 5; 100mg, De-escalation Cohort; 20mg, Cohort 1; 30 mg, Cohort 2; 40mg, Cohort 3; 60mg, Cohort 4; 80mg
Acute Myelogenous Leukemia Clinical Trial 2023: KPT-9274 Highlights & Side Effects. Trial Name: NCT04914845 — Phase 1
KPT-9274 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04914845 — Phase 1

Frequently Asked Questions

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

How many human subjects are engaged in this experiment?

"Affirmative, the clinicaltrials.gov website verifies that this investigation is currently enrolling members. The trial was initially published on August 27th 2021 and has been modified as recently as August 31st 2022. They are welcoming a total of 40 volunteers at 2 medical facilities."

Answered by AI

How does the 30mg dosage of Cohort 1 impact patient safety?

"Cohort 1; 30 mg has been granted a safety rating of 1 due to the limited clinical evidence that exists for its efficacy and potential dangers."

Answered by AI

Are there any vacancies in this research program for participants?

"Clinicaltrials.gov states that this research is currently enlisting participants, with initial posting occuring on August 27th 2021 and the latest update being made on August 31st 2022."

Answered by AI
~17 spots leftby Feb 2026