Acute LeukemiaPhase 1NCT05406817
Study of Radiolabeled Revumenib in Adults With Acute Leukemia
A Phase 1 study testing Revumenib in people with Acute Leukemia, run by Syndax Pharmaceuticals at 1 site in United States.
Trial summary
This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-revumenib in participants with acute leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Revumenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 18 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females (of non-childbearing potential) aged ≥18 years
- Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease.
- Previously received standard of care therapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Adequate liver and cardiac function
- Fertile males agree to use barrier contraception from the time of enrollment through 120 days after the last study drug dose
Who cannot join
- Active diagnosis of acute promyelocytic leukemia
- White blood cell (WBC) count >25,000/microliters at time of enrollment.
- Detectable human immunodeficiency virus viral load within the previous 6 months
- Hepatitis B or Hepatitis C
- Cardiac, gastrointestinal, or graft-versus-host disease (GVHD)
- History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or not be in the best interest of the participant to participate
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- Must not be receiving any moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducers
- Any commercially available or investigational antileukemic therapy other than revumenib except for short-term administration of corticosteroids and/or hydroxyurea for cytoreduction
- Participation in another therapeutic interventional clinical study in which an investigational agent was administered within 30 days before starting revumenib
- Any concurrent systemic treatment to prevent GVHD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia
This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-revumenib in participants with acute leukemia.
Read the detailed description
Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from revumenib may remain on study until progressive disease (PD) or unacceptable toxicity.
- Conditions
- Acute Leukemia
- Being tested
- Revumenib
- Keywords
- SNDX-5613, Acute Leukemia, Refractory leukemia, Relapsed leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevumenibDrug
Also called SNDX-5613
Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Revumenib | Experimental | Participants will be administered a single dose of revumenib (containing ~100 microcuries [14C]-revumenib) in the AME part of the study.
Each dose administered after the first dose in the AME part of the study will be nonradiolabeled revumenib. revumenib may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity. Receives: Drug: Revumenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Dose Excreted in Urine (feu)
Measured: Up to Day 11
Percentage of Dose Excreted in Feces (fef)
Measured: Up to Day 11
Amount Excreted in Urine (Aeu)
Measured: Up to Day 11
Amount Excreted in Feces (Aef)
Measured: Up to Day 11
Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t)
Measured: Up to Day 21
Maximum Observed Concentration (Cmax)
Measured: Up to Day 21
Secondary outcomes (1)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start5 Aug 2022
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole McNeer, MD, PhD, Study director, Syndax Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406817
- Sponsor's protocol ID
- SNDX-5613-0705
- Status last verified
- Jan 2025
- First submitted
- 1 Jun 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Assess the Mass Balance, Pharmacokinetics, and Metabolism of Orally Administered [14C]-SNDX-5613 in Patients With Relapsed/Refractory Acute Leukemia
- ClinicalTrials.gov ID
- NCT05406817
- Acronym / sponsor ID
- SNDX-5613-0705
- Conditions
- Acute Leukemia
- Keywords
- SNDX-5613, Acute Leukemia, Refractory leukemia, Relapsed leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Syndax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study to evaluate the absorption, metabolism, and excretion (AME) of carbon-14 ([14C])-revumenib in participants with acute leukemia.
Detailed description
Participants will be enrolled in this study primarily to complete the 11-day AME portion of the study; participants who are receiving benefit from revumenib may remain on study until progressive disease (PD) or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revumenib | Experimental | Drug: RevumenibParticipants will be administered a single dose of revumenib (containing ~100 microcuries [14C]-revumenib) in the AME part of the study. Each dose administered after the first dose in the AME part of the study will be nonradiolabeled revumenib. revumenib may continue to be administered following completion of the AME part of the study. Doses will be administered in continuous 28-day cycles until either PD or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females (of non-childbearing potential) aged ≥18 years
- Relapsed or refractory acute leukemia, including participants who are MRD-positive by multiparametric flow cytometry or next-generation sequencing, and including participants with isolated extramedullary disease.
- Previously received standard of care therapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Adequate liver and cardiac function
Key exclusion criteria (10 listed)
- Active diagnosis of acute promyelocytic leukemia
- White blood cell (WBC) count >25,000/microliters at time of enrollment.
- Detectable human immunodeficiency virus viral load within the previous 6 months
- Hepatitis B or Hepatitis C
- Cardiac, gastrointestinal, or graft-versus-host disease (GVHD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevumenibAlso: SNDX-5613Initial radiolabeled revumenib will be administered as an oral solution. Capsules will be administered thereafter. | Drug | Revumenib |
Primary outcome
Percentage of Dose Excreted in Urine (feu)
Time frame: Up to Day 11
Percentage of Dose Excreted in Feces (fef)
Time frame: Up to Day 11
Amount Excreted in Urine (Aeu)
Time frame: Up to Day 11
Amount Excreted in Feces (Aef)
Time frame: Up to Day 11
Area Under The Concentration Time Curve from Time 0 to The Last Measurable Concentration (AUC0-t)
Time frame: Up to Day 21
Maximum Observed Concentration (Cmax)
Time frame: Up to Day 21
1 secondary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: up to approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole McNeer, MD, PhD study director
Syndax Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Revumenib in people with Acute Leukemia, run by Syndax Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Dose Excreted in Urine (feu) (time frame: Up to Day 11). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.