Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daunorubicin · 1 trial · 1 indication
Will be summarized using the proportion and exact binomial confidence interval. DLTs will be summarized at each dose level by severity and major organ site according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
| Arm | Type | Description |
|---|---|---|
| Treatment (cytarabine, daunorubicin, pemigatinib) | EXPERIMENTAL | INDUCTION: Patients receive cytarabine IV on days 1-7, daunorubicin IV on days 1-3, and pemigatinib PO QD on days 8-21 in the absence of disease progression or unacceptable toxicity. Patients with hematologic count recovery (assessed between days 25-42) after induction proceed to consolidation therapy. Patients undergo ECHO during screening and as clinically indicated on study. Patients undergo blood sample collection and bone marrow aspirate and biopsy during screening and cycle 11 day 21 on study. CONSOLIDATION: Patients receive high dose cytarabine IV BID on days 1, 3, and 5 of each cycle, and pemigatinib PO QD on days 8-21 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression of unacceptable toxicity. Patients undergo ECHO as clinically indicated and blood sample collection and bone marrow biopsy and aspirate at the end of consolidation. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspirate | PROCEDURE | Undergo bone marrow biopsy and aspirate |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy and aspiratie |
| Cytarabine | DRUG | Given IV |
| Daunorubicin | DRUG | Given IV |
| Electrocardiography | PROCEDURE | Undergo ECHO |
| Pemigatinib | DRUG | Given PO |
Inclusion Criteria: * PRE-SCREENING INCLUSION CRITERIA: Ability to understand and the willingness to sign a written informed consent document * PRE-SCREENING INCLUSION CRITERIA: Age \>= 18 years at time of informed consent. Both men and women of all races and ethnic groups will be included * PRE-SC...
Daunorubicin is a small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 1 clinical development, meaning it is investigational and has not been approved for this use. The drug is being evaluated in combination with other therapies for newly diagnosed AML patients.
Daunorubicin is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Acute Myeloid Leukemia.
Daunorubicin is currently in Phase 1 clinical development for Acute Myeloid Leukemia. This is an early stage of testing, and the drug is still investigational. It has not yet been approved by regulatory authorities, and further clinical trials are needed to determine its safety and effectiveness.
Daunorubicin is being studied in a Phase 1 clinical trial with the identifier NCT04659616. This trial is titled 'Pemigatinib After Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia' and is currently recruiting participants in the United States. The trial is uncontrolled and not blinded, with an enrollment of 32 patients.
Daunorubicin is not FDA approved for the treatment of Acute Myeloid Leukemia. It is currently in Phase 1 clinical trials, which means it is still being tested for safety and efficacy. The drug is investigational and has not yet received regulatory approval for this indication.