Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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.
Not Available
Phase I
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics,
Supportive Care
Fludarabine,
G-CSF,
Gilteritinib,
High Dose Cytarabine (HD ARAC),
Idarubicin,
Low-dose cytarabine (LDAC),
Ziftomenib
Fedorov, Kateryna
National
Vanderbilt University
03-26-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Has been diagnosed with relapsed/refractory AML.
Has been diagnosed with relapsed/refractory AML.
Has a documented NPM1 mutation or KMT2A rearrangement.
Has a documented NPM1 mutation or KMT2A rearrangement.
Has a documented FLT3 mutation (cA-3 only).
Has a documented FLT3 mutation (cA-3 only).
Has an Eastern Cooperative Oncology Group (ECOG) Performance status 2.
Has an Eastern Cooperative Oncology Group (ECOG) Performance status 2.
Has adequate hepatic and renal function as defined per protocol.
Has adequate hepatic and renal function as defined per protocol.
Has an ejection fraction above a protocol defined limit.
Has an ejection fraction above a protocol defined limit.
Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
Has agreed to use contraception as defined per protocol.
Has agreed to use contraception as defined per protocol.
Exclusion Criteria:
Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
Has clinically active central nervous system leukemia.
Has clinically active central nervous system leukemia.
Has an active and uncontrolled infection.
Has an active and uncontrolled infection.
Has a mean corrected QT interval (QTcF) > 480ms.
Has a mean corrected QT interval (QTcF) > 480ms.
Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy 14 days or within 5 drug half-lives prior to the first dose of study intervention.
Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy 14 days or within 5 drug half-lives prior to the first dose of study intervention.
Has had major surgery within 4 weeks prior to the first dose of study intervention.
Has had major surgery within 4 weeks prior to the first dose of study intervention.
Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
Participant is pregnant or lactating.
Participant is pregnant or lactating.
Has been diagnosed with relapsed/refractory AML.
Has been diagnosed with relapsed/refractory AML.
Has a documented NPM1 mutation or KMT2A rearrangement.
Has a documented NPM1 mutation or KMT2A rearrangement.
Has a documented FLT3 mutation (cA-3 only).
Has a documented FLT3 mutation (cA-3 only).
Has an Eastern Cooperative Oncology Group (ECOG) Performance status 2.
Has an Eastern Cooperative Oncology Group (ECOG) Performance status 2.
Has adequate hepatic and renal function as defined per protocol.
Has adequate hepatic and renal function as defined per protocol.
Has an ejection fraction above a protocol defined limit.
Has an ejection fraction above a protocol defined limit.
Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
Has agreed to use contraception as defined per protocol.
Has agreed to use contraception as defined per protocol.
Exclusion Criteria:
Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
Has clinically active central nervous system leukemia.
Has clinically active central nervous system leukemia.
Has an active and uncontrolled infection.
Has an active and uncontrolled infection.
Has a mean corrected QT interval (QTcF) > 480ms.
Has a mean corrected QT interval (QTcF) > 480ms.
Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy 14 days or within 5 drug half-lives prior to the first dose of study intervention.
Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy 14 days or within 5 drug half-lives prior to the first dose of study intervention.
Has had major surgery within 4 weeks prior to the first dose of study intervention.
Has had major surgery within 4 weeks prior to the first dose of study intervention.
Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
Participant is pregnant or lactating.
Participant is pregnant or lactating.
