Clinical trials: Acute Myeloid Leukemia With FLT3/ITD Mutation
Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
This clinical trial aims to evaluate whether molecular MRD-guided chemotherapy can effectively treat FLT3-ITD mutated AML and potentially replace allogeneic hematopoietic stem cell transplantation.
- Conditions
- Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive, Intermediate Risk Acute Myeloid Leukemia, Fit Patients
- Trial name
- GANCE (NCT07259707)
- Testing
- GVA + HDAC Consolidation & Gilteritinib Maintenance
- Where
- China
- Volunteers
- 25 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Acute Myeloid Leukemia
Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physician's Choice in Newly Diagnosed FLT3-ITD+ AML
The orally administered second-generation bis-aryl urea tyrosine kinase inhibitor quizartinib is very specific for FLT3, has a high capacity for sustained FLT3-inhibition and an acceptable toxicity profile.
- Trial name
- Q-SOC (NCT04676243)
- Testing
- Quizartinib, Treatment according to Physician's Choice, Standard of Care Chemotherapy
- Sponsor
- University Hospital Heidelberg
Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults, AML (Adult) With 11q23 (MLL) Abnormalities
Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.
- Conditions
- Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults, AML (Adult) With 11q23 (MLL) Abnormalities, AML (Adult) With Del (5q), AML (Adult) With Inv (16) (p13; q22)
- Trial name
- NCT01846624
- Testing
- Decitabine, Midostaurin
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- David Iberri
Acute Myeloid Leukemia With Gene Mutations
Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib
An expanded access program (EAP): Allows doctors to give medicine to patients, Before it is approved by health authorities. This EAP is for: Quizartinib Patients with FLT3-ITD mutated AML, AML that has come back, or Is resistant…
- Trial name
- NCT03746912
- Testing
- Quizartinib Dihydrochloride
- Sponsor
- Daiichi Sankyo
Leukemia, Myeloid, Acute
Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This study will evaluate two doses of Quizartinib in patients with relapsed or refractory acute myeloid leukemia who are also FMS-like tyrosine kinase - internal tandem duplication ( FLT3-ITD) positive.
- Trial name
- NCT01565668
- Testing
- AC220
- Where
- 24 sites in United States, France and 2 more
- Volunteers
- 76 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations
Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies
This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies.
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM, Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214
- Trial name
- NCT01760655
- Testing
- Fludarabine phosphate, Busulfan, Total-Body Irradiation
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
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 (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1)…
- Trial name
- NCT02927262
- Testing
- Gilteritinib
- Where
- 73 sites in United States, Brazil and 19 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML).
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Acute Promyelocytic Leukemia With PML-RARA
- Trial name
- NCT01253070
- Testing
- Biopsy, Bone Marrow Aspiration, Cytarabine
- Where
- 43 sites in United States
- Volunteers
- 54 people
- Sponsor
- National Cancer Institute (NCI)
Leukemia, Myeloid, Acute
A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
This is a research study to be done at multiple sites in participants with advanced acute myeloid leukemia (AML) that have a mutation in Fms-like tyrosine kinase-3 internal tandem duplications (FLT3-ITD).
- Trial name
- NCT04209725
- Testing
- CPX-351, Quizartinib
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- SCRI Development Innovations, LLC
Acute Myeloid Leukemia
Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML
To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation
- Trial name
- MIDOKIT (NCT01830361)
- Testing
- midostaurin (PKC412)
- Where
- 10 sites in Germany
- Volunteers
- 18 people
- Sponsor
- Technische Universität Dresden
Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Acute Myeloid Leukemia
Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
This phase Ib/II trial studies the side effects and best dose of venetoclax in combination with quizartinib and how well they work in treating patients with acute myeloid leukemia that has come back or does not respond to…
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Acute Myeloid Leukemia, Refractory Acute Leukemia
- Trial name
- NCT03735875
- Testing
- Quizartinib, Venetoclax
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered emavusertib (CA-4948) monotherapy in adult patients with AML or higher- risk Myelodysplastic Syndrome (hrMDS).
- Trial name
- NCT04278768
- Testing
- Emavusertib, Venetoclax
- Where
- 32 sites in United States, Czechia and 6 more
- Volunteers
- 366 people
- Sponsor
- Curis, Inc.
Acute Myeloid Leukemia
Protocol in Acute Myeloid Leukemia With FLT3-ITD
This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.
- Trial name
- NCT01477606
- Testing
- Midostaurin, Cytarabine, Daunorubicin
- Where
- 55 sites in Austria, Germany
- Volunteers
- 451 people
- Sponsor
- University of Ulm
Acute Myeloid Leukemia
FLT3-ITD Gene Mutation and CD135 Expression in Acute Myeloid Leukemia.
1. To evaluate expression levels of CD135 2. To assess the frequency of FLT3 gene mutations (ITD) 3. association between FLT3-ITD mutation and CD135 expression and their correlation with hematological, immunophenotypic,and…
- Trial name
- NCT05383014
- Volunteers
- 82 people
- Sponsor
- Assiut University
Acute Myeloid Leukemia
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML).
- Trial name
- NCT01349049
- Testing
- PLX3397
- Where
- 9 sites in United States
- Volunteers
- 90 people
- Sponsor
- Daiichi Sankyo
AML, Adult
HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.
This is a non-randomized prospective open-label single-arm clinical phase I trial investigating dose finding, feasibility and safety of the combined treatment of HDM201 and midostaurin in patients with relapsed/refractory acute…
- Trial name
- HDMM (NCT04496999)
- Testing
- HDM201, Midostaurin
- Where
- Switzerland
- Volunteers
- 2 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of the phase 1 portion (dose escalation) of the study was to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in…
- Trial name
- NCT04240002
- Testing
- gilteritinib, fludarabine, cytarabine
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.