Expanded Access to Ziftomenib

NCT05738538 | Unknown

• 1 other identifier: Expanded Access to Ziftomenib
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 NPM1 mutations or KMT2A rearrangements. To request access, use Responsible Party contact information provided in this record. Expanded access for ziftomenib is only available in the United States.

Conditions

Acute Lymphoblastic Leukemia, With Appropriate Mutations; Acute Myeloid Leukemia, With NPM1 Mutations

Interventions

ziftomenib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kura Oncology, Inc.: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Central Study Contacts

Clinical Operations

CONTACT

617-588-3755; ExpandedAccess@kuraoncology.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 22, 2023
• Last Updated: June 4, 2025

Record last verified: 2025-05