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Trial Title:
Expanded Access to Ziftomenib
NCT ID:
NCT05738538
Condition:
Acute Lymphoblastic Leukemia, With Appropriate Mutations
Acute Myeloid Leukemia, With NPM1 Mutations
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
ziftomenib
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
Criteria for eligibility:
Criteria:
Inclusion/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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Lead sponsor:
Agency:
Kura Oncology, Inc.
Agency class:
Industry
Source:
Kura Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05738538
