Rydapt (midostaurin) / Novartis 
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16 Trials

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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
More
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
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
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
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
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
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
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
 
 

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