- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05738538
Expanded Access to Ziftomenib
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Study Contact
- Name: Kura Oncology Expanded Access
- Phone Number: 858-500-8800
- Email: ExpandedAccess@kuraoncology.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Expanded Access to Ziftomenib
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Lymphoblastic Leukemia, With Appropriate Mutations
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Daiichi Sankyo, Inc.No longer availableAcute Myeloid Leukemia With Gene Mutations
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Arog Pharmaceuticals, Inc.RecruitingRelapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating MutationsUnited States, Germany, Spain, Italy, France, Canada
-
University College, LondonNot yet recruitingAcute Lymphoblastic Leukemia, Pediatric | Acute Lymphoblastic Leukemia, in Relapse | Acute Lymphoblastic Leukemia, Adult | Acute Lymphoblastic Leukemia With Failed Remission | Acute Lymphoblastic Leukemia Not Having Achieved Remission
-
Stanford UniversityWithdrawnAdult Acute Myeloid Leukemia in Remission | Acute Myeloid Leukemia With Gene Mutations
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingRecurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | Adult Acute Myeloid Leukemia With Del(5q) | Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia With t(8... and other conditionsUnited States
-
Arog Pharmaceuticals, Inc.CompletedNewly Diagnosed AML With FLT3 Activating MutationsUnited States
-
National Cancer Institute (NCI)Active, not recruitingAcute Lymphoblastic Leukemia | Recurrent Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | Adult T Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | Adult L1 Acute Lymphoblastic Leukemia | Adult L2 Acute Lymphoblastic...United States
-
Arog Pharmaceuticals, Inc.CompletedPhase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating MutationsRelapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating MutationsUnited States
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinRecruitingAcute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia, Pediatric | Acute Lymphoblastic Leukemia, in Relapse | Acute Lymphoblastic Leukemia Recurrent | Acute Lymphoblastic Leukemia With Failed Remission | Acute Lymphoblastic Leukemia Not Having Achieved RemissionUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedSecondary Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia in Remission | Childhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 and other conditionsUnited States
Clinical Trials on ziftomenib
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Kura Oncology, Inc.RecruitingAcute Myeloid Leukemia | Acute Leukemia of Ambiguous Lineage | Advanced Malignant Neoplasm | Mixed Phenotype Acute Leukemia | Mixed Lineage Leukemia | Mixed Lineage Acute LeukemiaUnited States, Spain, United Kingdom, France, Germany, Canada, Belgium, Italy
-
LLS PedAL Initiative, LLCKura OncologyNot yet recruitingRelapsed/Refractory KMT2A-r Acute Leukemia | Relapsed/Refractory NUP98-r Acute Leukemia | Relapsed/Refractory NPM1-m Acute Leukemia
-
Kura Oncology, Inc.RecruitingAcute Myeloid Leukemia | Acute Myeloid Leukemia, in Relapse | Myeloid Sarcoma | Acute Myeloid Leukemia Recurrent | Mixed Phenotype Acute Leukemia | Mixed Lineage Acute Leukemia | Refractory AML | NPM1 Mutation | Mixed Lineage Leukemia Gene Mutation | AML With Mutated NPM1 | KMT2ArUnited States
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Kura Oncology, Inc.RecruitingNeoplasms by Histologic Type | Acute Myeloid Leukemia | Leukemia | Leukemia, Myeloid | Leukemia, Myeloid, Acute | AML | Acute Leukemia | Hematologic Malignancy | NPM1 Mutation | AML With Mutated NPM1 | KMT2Ar | MLL RearrangementUnited States
-
Tanja Andrea GruberAmgen; Kura Oncology, Inc.; Pediatric Oncology Experimental Therapeutics Investigators... and other collaboratorsRecruitingLymphoblastic LeukemiaUnited States