Rydapt (midostaurin) / Novartis 
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28 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Rydapt (midostaurin) / Novartis
RATIFY, NCT00651261 / 2006-006852-37: Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Checkmark AML patients with FLT3 mutations
Dec 2015 - Dec 2015: AML patients with FLT3 mutations
Checkmark RATIFY trial for AML with FLT3 mutations at ASH 2015
Dec 2015 - Dec 2015: RATIFY trial for AML with FLT3 mutations at ASH 2015
Checkmark RATIFY trial in AML
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Active, not recruiting
3
717
Canada, US
cytarabine, daunorubicin, midostaurin, placebo, dexamethasone acetate
Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI), Novartis Pharmaceuticals
Leukemia
07/16
 
NCT03258931: Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

Recruiting
3
510
US
Crenolanib, Crenolanib besylate, Midostaurin, Cytarabine, Duanorubicin
Arog Pharmaceuticals, Inc.
Newly Diagnosed FLT3 Mutated AML
11/22
11/24
AMELIORATE, NCT04174612: AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

Recruiting
3
172
Europe
Cytarabine, Daunorubicin, Midostaurin, Cytarabine HD
Gruppo Italiano Malattie EMatologiche dell'Adulto
Acute Myeloid Leukemia With FLT3/ITD Mutation
12/22
08/25
HOVON 156 AML, NCT04027309 / 2018-000624-33: A 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 or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

Active, not recruiting
3
777
Europe, RoW
Gilteritinib, ASP2215, Midostaurin, Rydapt
Stichting Hemato-Oncologie voor Volwassenen Nederland, Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG), Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
12/24
06/33
NCT03092674: Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Active, not recruiting
2/3
76
US
Azacitidine, 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Decitabine, 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine, Laboratory Biomarker Analysis, Midostaurin, CGP 41251, CGP41251, N-Benzoyl-Staurosporine, N-Benzoylstaurosporine, PKC 412, PKC-412, PKC412, Rydapt, Nivolumab, ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo
National Cancer Institute (NCI)
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome/Acute Myeloid Leukemia
08/23
10/24
2017-002094-18: Prospective evaluation of a continuation therapy with Midostaurin in adult patients withcore-binding factor leukemia and integrated genetic analysis: a multi-center phase II study Studio multicentrico di fase II. Valutazione prospettica di una terapia continuativa con Midostaurina in pazienti adulti con leucemia mieloide acuta "core-binding factor"

Ongoing
2
39
Europe
Midostaurina, [PKC412], Capsule, soft
AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA, Novartis x midostaurina
Acute Myeloid Leukemia (AML) Leucemia Mieloide Acuta, Acute Myeloid Leukemia (AML) Leucemia Mieloide Acuta, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
NCT03280030: A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML

Hourglass Jul 2021 - Dec 2021 : Final data from trial for newly diagnosed patients with FLT3-mutated AML
Completed
2
75
Japan, RoW
Midostaurin, PKC412, Placebo
Novartis Pharmaceuticals
Acute Myeloid Leukemia
03/20
11/22
HO155, NCT04097470 / 2018-000047-31: Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients

Active, not recruiting
2
140
Europe
Decitabine, Dacogen, Midostaurin, Rydapt
Stichting Hemato-Oncologie voor Volwassenen Nederland, Swiss Group for Clinical Cancer Research
AML/MDS
11/21
11/26
AML FLT3, NCT03686345 / 2017-002094-18: Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia

Recruiting
2
39
Europe
Midostaurin
Niguarda Hospital, Novartis x midostaurina
Core Binding Factor Acute Myeloid Leukemia (CBF-AML)
06/23
12/25
PrE0905, NCT03836209: Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

Active, not recruiting
2
181
US
Gilteritinib, ASP2215, Midostaurin, RYDAPT, Daunorubicin, Daunorubicin hydrochloride, Daunomycin, Rubidomycin, Cerubidine, Cytarabine, Cytosar-U, Ara-C, Arabinosyl, Cytosine Arabinoside
PrECOG, LLC., Astellas Pharma Inc
Acute Myeloid Leukemia
10/23
12/24
P30CA036727, NCT03226418: Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

Active, not recruiting
2
75
US
Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Decitabine, 5-Aza-2'-deoxycytidine, Aza-TdC, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine, Idarubicin, 4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-DMDR, Laboratory Biomarker Analysis, Liposome-encapsulated Daunorubicin-Cytarabine, CPX-351, Cytarabine-Daunorubicin Liposome for Injection, Liposomal AraC-Daunorubicin CPX-351, Liposomal Cytarabine-Daunorubicin, Liposome-encapsulated Combination of Daunorubicin and Cytarabine, Vyxeos, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Azacitidine, VIDAZA, Venetoclax, Venclexta, Venclyxto, glasdegib, Daurismo
University of Nebraska, National Cancer Institute (NCI)
Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
10/24
10/24
NCI-2014-01103, NCT02115295: Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Recruiting
2
508
US
Cladribine, 2-CdA, 2CDA, CdA, Cladribina, Leustat, Leustatin, Leustatine, RWJ-26251, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Gilteritinib, ASP-2215, ASP2215, Xospata, Idarubicin, 4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-DMDR, Laboratory Biomarker Analysis, Midostaurin, CGP 41251, CGP41251, N-Benzoyl-Staurosporine, N-Benzoylstaurosporine, PKC-412, PKC412, Rydapt, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Blasts 10 Percent or More of Peripheral Blood White Cells, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Acute Myeloid Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
05/25
05/26
NCT03591510 / 2017-004830-28: A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

Calendar Jan 2025 - Dec 2025: Data from trial in newly diagnosed pediatric patients with FLT3-mutated acute AML
Recruiting
2
23
Europe, Japan, US, RoW
Midostaurin, PKC412, Fludarabine, Part 1 Block 2 induction FLADx, Cytarabine, Part 1:, Block 2 induction FLADx, Block 3 consolidation HAM, Block 4 consolidation HA3E, Block 5 consolidation HIDAC, Part 2:, Block 2 induction HAM, Block 3 consolidation HA3E, Block 4 consolidation HAM, Daunorubicin or idarubicin, Mitoxantrone, Etoposide
Novartis Pharmaceuticals
FLT3-mutated Acute Myeloid Leukemia
08/25
02/29
DEXAML-02, NCT03609060: Dexamethasone Added to Intensive Chemotherapy in Older Patients with Acute Myeloid Leukemia (AML)

Active, not recruiting
2
120
Europe
Dexamethasone
French Innovative Leukemia Organisation
Acute Myeloid Leukemia
08/25
12/25
NCT02756962: Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance

Active, not recruiting
2
107
US
Cytarabine, Ara-C, Cytosar-U, Tarabine-PFS, AraC, Allogeneic stem cell transplant, AlloSCT, Bone marrow aspiration, Punch skin biopsy, ClinSeq
Washington University School of Medicine, The Leukemia and Lymphoma Society, American Society of Hematology
Acute Myeloid Leukemia
07/29
07/29
2017-002335-42: A study about the treatment of patients with a specific type of AML with a combination of panobinostat and midostaurin during 1 year after allogeneic stem cell transplantation . Onderzoek naar de behandeling van patiënten met een specifiek type AML, met de middelen panobinstat en midostaurin gedurende 1 jaar na donor-stamceltransplantatie.

Ongoing
1/2
40
Europe
panobinostat, Midostaurin, Capsule, Farydak 20 mg, Rydapt
HOVON Foundation, Novartis
adverse risk AML or RAEB, 'High risk' acute myeloid leukemia of myedysplastic syndrome, Diseases [C] - Cancer [C04]
 
 
MOSAIC, NCT04385290 / 2019-003863-23: Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia

Recruiting
1/2
214
Europe
MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO, Rydapt, Mylotarg, MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO, MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO, MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin, MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin
Technische Universität Dresden, Novartis Pharmaceuticals, Pfizer
Acute Myeloid Leukemia
04/27
04/28
NCT04982354: Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

Withdrawn
1/2
20
US
CPX-351, Midostaurin, Rydapt, Busulfan, Myleran, Melphalan, Alkeran, Fludarabine, Fludara, CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
Guenther Koehne, Jazz Pharmaceuticals
Acute Myeloid Leukemia
08/31
08/32
V-FAST master, NCT04075747: A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Completed
1b
57
US
CPX-351, Vyxeos, JZP351, Venetoclax, Venclexta, Midostaurin, Rydapt, Enasidenib, Idhifa
Jazz Pharmaceuticals
Acute Myeloid Leukemia
02/22
09/23
NCT00819546: RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS

Checkmark P1 data - ASH 2012
Nov 2012 - Nov 2012: P1 data - ASH 2012
Active, not recruiting
1
29
US
RAD001, everolimus, PKC412, midostaurin
Richard Stone, MD, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Novartis
Acute Myeloid Leukemia, Myelodysplastic Syndrome
12/25
12/25
NCI-2019-01726, NCT03900949: Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia

Recruiting
1
18
US
Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation, Allogeneic, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Daunorubicin Hydrochloride, Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem, Gemtuzumab Ozogamicin, Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab, hP67.6-Calicheamicin, Mylotarg, WAY-CMA-676, Midostaurin, CGP 41251, CGP41251, N-Benzoyl-Staurosporine, N-Benzoylstaurosporine, PKC-412, PKC412, Rydapt
Uma Borate
Acute Myeloid Leukemia
01/25
01/25
AML-VAC-XS15, NCT06252584: Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients

Not yet recruiting
1
20
NA
Vaccines, Peptide, Multipeptide Vaccine AML-VAC-XS15
University Hospital Tuebingen
Acute Myeloid Leukemia, Adult
05/26
11/26
NCT06313437: Revumenib in Combination With 7+3 + Midostaurin in AML

Not yet recruiting
1
22
US
Revumenib, SNDX-5613, Trans N-ethyl-2-((4-(7-((4-(ethylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2- yl)pyrimidin-5-yl)oxy)-5-fluoro-N-isopropylbenzamide, Midostaurin, Rydapt, Cytarabine, cytosine arabinoside (ara-C), Daunorubicin, Daunomycin
Maximilian Stahl, MD, Syndax Pharmaceuticals
Acute Myeloid Leukemia, AML, Adult, AML With Gene Mutations, AML, Leukemia
03/26
03/27
NCT03114228: An Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML)

No Longer Available
N/A
Canada
Midostaurin
Novartis Pharmaceuticals
FLT3-mutated Acute Myeloid Leukemia
 
 
AMLFLT3, NCT02624570: Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy

No Longer Available
N/A
US
Midostaurin, PKC412
Novartis Pharmaceuticals
Acute Myeloid Leukemia (AML) With, FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)
 
 
NCT05219266: Managed Access Programs for PKC412, Midostaurin

No Longer Available
N/A
NA
midostaurin, PKC412
Novartis Pharmaceuticals
FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia, Acute Myeloid Leukemia, Aggressive Systemic Mastocytosis, Mast Cell Leukemia, Systemic Mastocytosis With an Associated Hematologic Neoplasm
 
 
ALFAPPP, NCT04777916: Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)

Recruiting
N/A
2500
Europe
Acute Leukemia French Association
Acute Myeloid Leukemia (AML)
04/32
04/46
DYNHAEMICS, NCT05304156: Single-cell Dynamic Profiling in Adults With Newly Diagnosed Acute Myeloid Leukemia Treated With Intensive Chemotherapy. A THEMA Study"

Recruiting
N/A
200
Europe
Biobanking blood and bone marrow specimens
Assistance Publique - Hôpitaux de Paris
Acute Myeloid Leukemia
04/26
05/26

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