Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Neoplasms

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Cytarabine

Fludarabine

Fludarabine phosphate

Lenograstim

Gilteritinib

Idarubicin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Adjuvants, Immunologic

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Oral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts:

A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA

A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)

A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib

B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA

B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)

Oral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation/expansion cohorts:

A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA

A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)

A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib

B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA

B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)

Ziftomenib

Granulocyte colony-stimulating factor

Clinical Operations

Farah Fasihuddin

KUCC Navigation Team

Cathy Galasso

Kristyn Dailey

Aaron Goldberg, MD, PhD

Cynthia J Lowery

Lisa Johnson

Fiona Davidson

Allison Pike

Ghayas C Issa, MD

Clinical Development

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

To assess proportion of patients alive at 6 months

To assess minimum residual disease in bone marrow as assessed by multiparameter flow cytometry (MFC) and molecular analysis

To assess proportion of patients that undergo a hematopoietic stem-cell transplant

To assess rate of transfusion independence

To assess the maximum plasma combination of ziftomenib and its metabolites

To assess the time to observed maximum plasma concentration of ziftomenib and its metabolites

To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of ziftomenib and its metabolites

To assess the area under the plasma concentration-time-curve over a dosing interval for ziftomenib and its metabolites

To assess the maximum plasma combination of gilteritinib

To assess the time to observed maximum plasma concentration of gilteritinib

To assess the area under the plasma concentration-time-curve from time 0 to time of last measurable concentration of gilteritinib

To assess the area under the plasma concentration-time-curve over a dosing interval for gilteritinib

Spots Global Cancer Trial Database for kmt2ar

Every month we try and update this database with for kmt2ar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kmt2ar

Every month we try and update this database with for kmt2ar cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kmt2ar cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.