Acute Lymphoblastic Leukemia, With KMT2A RearrangementsNCT05738538
Expanded Access to Ziftomenib
A study testing ziftomenib in people with Acute Lymphoblastic Leukemia, With KMT2A Rearrangements and Acute Myeloid Leukemia, With NPM1 Mutations, run by Kura Oncology, Inc..
Trial summary
Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL) with KMT2A rearrangements, or Acute Myeloid Leukemia (AML), with KMT2A rearrangements, or frontline AML patients with NPM1 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, With KMT2A Rearrangements, Acute Myeloid Leukemia, With NPM1 Mutations, Acute Myeloid Leukemia, With KMT2A Rearrangements
- What is being tested?
- ziftomenib
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).
- Adult, ages 18+.
- Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. For newly diagnosed AML patients with either NPM1-mutant, or KMT2A-rearranged AML, ziftomenib therapy will be considered for patients not eligible for ongoing clinical trials. In the case of patients with KMT2A-rearranged AML, Expanded Access to ziftomenib will only be provided for use in combination with FDA-approved therapies currently under clinical investigation at Kura Oncology (e.g., venetoclax + azacitidine, cytarabine + daunorubicin).
- Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.
- Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL) with KMT2A rearrangements, or Acute Myeloid Leukemia (AML), with KMT2A rearrangements, or frontline AML patients with NPM1 mutations.
To request access, use Responsible Party contact information provided in this record.
Expanded access for ziftomenib is only available in the United States.
Read the detailed description
- Subsection Condition:
- NPM1 mutation in frontline AML patients
- KMT2A rearrangement in AML patients
- KMT2A rearrangement in ALL patients
- Conditions
- Acute Lymphoblastic Leukemia, With KMT2A Rearrangements, Acute Myeloid Leukemia, With NPM1 Mutations, Acute Myeloid Leukemia, With KMT2A Rearrangements
- Being tested
- ziftomenib
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziftomenibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, With KMT2A RearrangementsStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Kura Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738538
- Sponsor's protocol ID
- Expanded Access to Ziftomenib
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Ziftomenib
- ClinicalTrials.gov ID
- NCT05738538
- Acronym / sponsor ID
- Expanded Access to Ziftomenib
- Conditions
- Acute Lymphoblastic Leukemia, With KMT2A Rearrangements, Acute Myeloid Leukemia, With NPM1 Mutations, Acute Myeloid Leukemia, With KMT2A Rearrangements
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Kura Oncology, Inc.Industry (pharma, biotech, devices)
- First posted
- 22 Feb 2023 (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.
Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL) with KMT2A rearrangements, or Acute Myeloid Leukemia (AML), with KMT2A rearrangements, or frontline AML patients with NPM1 mutations.
To request access, use Responsible Party contact information provided in this record.
Expanded access for ziftomenib is only available in the United States.
Detailed description
- Subsection Condition:
- NPM1 mutation in frontline AML patients
- KMT2A rearrangement in AML patients
- KMT2A rearrangement in ALL patients
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).
- Adult, ages 18+.
- Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. For newly diagnosed AML patients with either NPM1-mutant, or KMT2A-rearranged AML, ziftomenib therapy will be considered for patients not eligible for ongoing clinical trials. In the case of patients with KMT2A-rearranged AML, Expanded Access to ziftomenib will only be provided for use in combination with FDA-approved therapies currently under clinical investigation at Kura Oncology (e.g., venetoclax + azacitidine, cytarabine + daunorubicin).
- Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.
- Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ziftomenib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ziftomenib in people with Acute Lymphoblastic Leukemia, With KMT2A Rearrangements and Acute Myeloid Leukemia, With NPM1 Mutations, run by Kura Oncology, Inc..
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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kura Medical Information (844-KURAONC (844-587-2662), medinfo@kuraoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 29 Jun 2026.