Gemtuzumab + Midostaurin for Acute Myeloid Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that no prior systemic anti-AML therapies, except for hydroxyurea, are allowed before starting the study treatment. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug combination of Gemtuzumab and Midostaurin for treating Acute Myeloid Leukemia?
Research shows that Midostaurin, when added to standard chemotherapy, improves survival rates in patients with a specific mutation (FLT3) in Acute Myeloid Leukemia. Additionally, Gemtuzumab combined with other drugs has shown effectiveness in achieving remission in high-risk AML patients, suggesting potential benefits when used together with Midostaurin.12345
Is the combination of Gemtuzumab and Midostaurin safe for treating acute myeloid leukemia?
The combination of Gemtuzumab (Mylotarg) and Midostaurin with chemotherapy has been studied for safety in treating acute myeloid leukemia. Common side effects of Gemtuzumab include fever, chills, and low blood cell counts, while Midostaurin's common side effects are fever, nausea, and diarrhea. Both drugs have shown a manageable safety profile in clinical trials.12678
What makes the drug combination of Gemtuzumab and Midostaurin unique for treating acute myeloid leukemia?
What is the purpose of this trial?
This phase I study hopes to explore how safe and tolerable is the combination of gemtuzumab ozogamicin (GO) and midostaurin, with the standard induction therapy (cytarabine and daunorubicin) in patients with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia (AML). GO is FDA approved for the treatment of adults with newly diagnosed CD33 positive AML and used in combination with chemotherapy, cytarabine and daunorubicin. Midostaurin is FDA approved for use with cytarabine and daunorubicin in patients with FLT3-mutated AML. By combining standard induction therapy with GO and midostaurin, our aim is to investigate a novel approach to treating patients with newly diagnosed FLT3-mutated AML.
Research Team
Uma Borate, MD
Principal Investigator
The Ohio State Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia (AML) who can sign consent, have an ECOG status of ≤2, and CD33 positive AML. They must not have had previous AML treatments, no active HIV or hepatitis B/C, and agree to contraception use. Those with severe heart issues, uncontrolled infections or certain allergies are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Patients receive cytarabine IV on days 1-7, daunorubicin IV on days 1-3, midostaurin 50mg PO BID on days 8-21, and gemtuzumab ozogamicin IV on specified days depending on dose level
Re-Induction Therapy
Patients with at least 5% bone marrow blasts may receive a single 28-day cycle of cytarabine and daunorubicin with or without midostaurin
Consolidation Therapy
Patients receive high dose cytarabine and gemtuzumab ozogamicin, with midostaurin for up to 2 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cytarabine
- Daunorubicin Hydrochloride
- Gemtuzumab Ozogamicin
- Midostaurin
Cytarabine is already approved in United States, European Union, Canada for the following indications:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
- Meningeal leukemia
- Lymphomatous meningitis
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
Uma Borate
Lead Sponsor