Expanded Access to Ziftomenib

• Conditions: Acute Lymphoblastic Leukemia, With Appropriate Mutations; Acute Myeloid Leukemia, With NPM1 Mutations

• Registration Number: NCT05738538
• Lead Sponsor: Kura Oncology, Inc.

Brief Summary

Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL), with appropriate mutations, or Acute Myeloid Leukemia (AML), 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

Not available

Study Timeline

• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

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.

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

For AML patients: Does not have KMT2A rearrangement

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified