Clinical trials: AML With FLT3 Mutation
Newly Diagnosed FLT3 Mutated AML
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in…
- Trial name
- NCT03258931
- Testing
- Crenolanib, Midostaurin, Cytarabine
- Where
- 31 sites in United States
- Volunteers
- 214 people
- Sponsor
- Arog Pharmaceuticals, Inc.
AML With FLT3 Mutation
A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with…
- Trial name
- NCT03182244
- Testing
- Gilteritinib, Cytarabine, Mitoxantrone
- Where
- 49 sites in China, Malaysia and 3 more
- Volunteers
- 276 people
- Sponsor
- Astellas Pharma Inc
AML With Gene Mutations
Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia
This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia
- Trial name
- NCT06366789
- Testing
- ZE46-0134
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 150 people
- Sponsor
- Lomond Therapeutics Holdings, Inc.
Acute Myeloid Leukemia
Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)
Participants with AML that have gone into remission and come back (relapsed) or gone into remission with a number of leukemia cells still in their system (refractory) will be recruited for this study.
- Trial name
- NCT03552029
- Testing
- Quizartinib, Milademetan
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia, Myelodysplastic Syndromes
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2.
- Trial name
- NCT00045942
- Testing
- Itraconazole, PKC412
- Where
- 4 sites in United States
- Volunteers
- 144 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies
To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies.
- Trial name
- HERKULES-4 (NCT05279859)
- Testing
- ERAS-007, ERAS-601, Gilteritinib
- Where
- 4 sites in United States
- Sponsor
- Erasca, Inc.
Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia
A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)
The primary objective of this study is to evaluate the safety of lanraplenib (LANRA) in combination with the FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib, in participants with relapsed or refractory (R/R) FLT3-mutated…
- Conditions
- Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT05028751
- Testing
- Lanraplenib, Gilteritinib
- Where
- 17 sites in United States, Spain
- Volunteers
- 24 people
- Sponsor
- Kronos Bio
Acute Myeloid Leukemia, Leukemia
A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status
Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
- Conditions
- Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndrome, AML
- Trial name
- NCT00462761
- Testing
- AC220
- Where
- 5 sites in United States, Georgia
- Volunteers
- 76 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia, FLT3-mutated Acute Myeloid Leukemia
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status…
- Trial name
- NCT02310321
- Testing
- Gilteritinib, Idarubicin, Cytarabine
- Where
- 55 sites in Japan, South Korea and 1 more
- Volunteers
- 97 people
- Sponsor
- Astellas Pharma Inc
Leukemia, Myeloid
Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.
- Trial name
- NCT00030186
- Testing
- CEP-701 60mg, Cep-701 80mg, Cep-701 40mg
- Volunteers
- 37 people
- Sponsor
- Cephalon
Acute Myeloid Leukemia With FLT3/ITD Mutation
A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
This study plans to enroll 45 (Groups A, B, and C) to 75 healthy participants (including the sample size of other potential dose groups). The participants will be divided into three dose groups: 37.5 mg, 75 mg, and 150 mg.
- Trial name
- XY0206-CQT (NCT07162116)
- Testing
- XY0206, Moxifloxacin (400 mg)
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
FLT3-mutated Acute Myeloid Leukemia
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)
The purpose of this study is to gather and evaluate additional safety data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute…
- Trial name
- NCT03114228
- Testing
- Midostaurin
- Where
- 2 sites in Canada
- Sponsor
- Novartis Pharmaceuticals
FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia, Acute Myeloid Leukemia
Managed Access Programs for PKC412, Midostaurin
The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.
- Conditions
- FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia, Acute Myeloid Leukemia, Aggressive Systemic Mastocytosis, Mast Cell Leukemia
- Trial name
- NCT05219266
- Testing
- midostaurin
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia (AML)
A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-Mutated
This is a randomized，multicenter, open-label Phase III, clinical study to confirm the efficacy and safety of SKLB1028 in patients with relapsed or refractory(R/R) FLT3-Mutated Acute Myeloid Leukemia（AML）compared to salvage…
- Trial name
- ALIVE (NCT04716114)
- Testing
- SKLB1028, Salvage Chemotherapy
- Where
- China
- Volunteers
- 315 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation…
- Trial name
- NCT03250338
- Testing
- Crenolanib, Cytarabine, Mitoxantrone
- Where
- 62 sites in United States, Canada and 4 more
- Volunteers
- 106 people
- Sponsor
- Arog Pharmaceuticals, Inc.
Acute Myeloid Leukemia (AML) With, FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)
Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor…
- Trial name
- AMLFLT3 (NCT02624570)
- Testing
- Midostaurin
- Where
- 44 sites in United States
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic…
- Trial name
- ACE (NCT00989261)
- Testing
- Compound AC220
- Where
- 85 sites in United States, Canada and 7 more
- Volunteers
- 333 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia
A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single agent continuation therapy in newly diagnosed patients…
- Trial name
- NCT03280030
- Testing
- Midostaurin
- Where
- 34 sites in Hong Kong, Japan and 4 more
- Volunteers
- 67 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
- Trial name
- RADIUS (NCT01883362)
- Testing
- Midostaurin, Standard of Care
- Where
- 19 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
AML, MDS
A Study of E6201 for the Treatment of Advanced Hematologic Malignancies With FLT3 and/or Ras Mutations
This is a Phase 1/2a dose-escalation study of E6201, a dual mitogen-activated protein kinase/extracellular-signal regulated kinase 1 (MEK1) and FMS-like tyrosine kinase 3 (FLT3) inhibitor, in subjects with advanced hematologic…
- Conditions
- AML, MDS, CMML
- Trial name
- NCT02418000
- Testing
- E6201
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Spirita Oncology, LLC