Product
Midostaurin
Aliases
CGP41251, CGP 41251, N-Benzoylstaurosporine, N-Benzoyl-Staurosporine (3 other aliases)
Name
RYDAPT
INN Name
RYDAPT
FDA Approved
Yes
13 clinical trials
1 organization
16 indications
1 document
Indication
Acute Myeloid LeukemiaIndication
acute myeloid leukemiaIndication
AdultIndication
LeukemiaIndication
Acute Biphenotypic LeukemiaIndication
Blast Phase Chronic Myelogenous LeukemiaIndication
BCR-ABL1-positiveIndication
Myelodysplastic SyndromeIndication
Recurrent Acute Myeloid LeukemiaIndication
Chronic Myelogenous LeukemiaIndication
Adult Acute Myeloid Leukemia (AML)Clinical trial
A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AMLStatus: Recruiting, Estimated PCD: 2025-08-18
Clinical trial
A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of Twice Daily Oral Midostaurin in Combination With Daunorubicin/Cytarabine Induction, High-dose Cytarabine Consolidation, and Midostaurin Single Agent Continuation Therapy in Newly Diagnosed Patients With FLT3-mutated Acute Myeloid Leukemia (AML).Status: Completed, Estimated PCD: 2020-03-11
Clinical trial
A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)Status: Completed, Estimated PCD: 2021-02-12
Clinical trial
V-FAST: A Phase 1b Master Trial to Investigate CPX-351 Combined With Various Targeted Agents in Subjects With Previously Untreated Acute Myeloid LeukemiaStatus: Completed, Estimated PCD: 2022-02-07
Clinical trial
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) With a Focus on Patients Treated With Rydapt (Midostaurin) in Helsinki and Uusimaa Hospital DistrictStatus: Completed, Estimated PCD: 2021-01-26
Clinical trial
Prospective Evaluation of a Continuation Therapy With Midostaurin in Adult Patients With Core-binding Factor Leukemia and Integrated Genetic Analysis: a Multi-center Phase II StudyStatus: Recruiting, Estimated PCD: 2023-06-30
Clinical trial
A Phase I Trial of Revumenib in Combination With 7+3 (7 Days of Cytarabine and 3 Days of Daunorubicin) + Midostaurin Induction Chemotherapy for the Frontline Treatment of NPM1 and FLT3 Mutated AMLStatus: Not yet recruiting, Estimated PCD: 2026-03-02
Clinical trial
Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)Status: Active (not recruiting), Estimated PCD: 2023-10-17
Clinical trial
Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CMLStatus: Recruiting, Estimated PCD: 2025-05-31
Clinical trial
MidOStaurin + Gemtuzumab OzogAmIcin Combination in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)Status: Recruiting, Estimated PCD: 2027-04-01
Clinical trial
A Phase 3, Multicenter, Open-label, Randomized, Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes With Excess Blasts-2 (MDS-EB2) With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML / AMLSG 28-18)Status: Active (not recruiting), Estimated PCD: 2024-12-01
Clinical trial
A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected AllograftStatus: Recruiting, Estimated PCD: 2031-08-01
Clinical trial
A Phase I Study to Evaluate the Safety and Tolerability of Gemtuzumab Ozogamicin and Midostaurin When Used in Combination With Standard Cytarabine and Daunorubicin Induction for Newly Diagnosed FLT3-mutated Acute Myeloid LeukemiaStatus: , Estimated PCD: 2025-01-01
Document
DailyMed Label: RYDAPTOrganization
Novartis Pharmaceuticals Corporation