Phase 2 N=5 A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
Acute Myeloid Leukemia
Primary: Percentage of Safety Events (Part 1, Japan Only) — 5; 0 Participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=501 A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML)
Primary: Event Free Survival (EFS) — 5.98; 5.88 Months
Phase 2 N=44 A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
Newly Diagnosed AML With FLT3 Activating Mutations
Primary: Clinical Response to Crenolanib With Standard Induction Chemotherapy — 26; 12; 38; 22 Participants
Phase 3 N=301 Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.
Acute Myeloid Leukemia
Primary: Percentage of Patients With Adverse Events (AEs), Grade 3 & 4 AEs, Serious Adverse Events (SAEs), AEs Leading to Discontinuation, and Deaths up to 24 Months (M24)…
Phase 2 N=13 Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Primary: Overall Response Rate — 5; 2; 3; 1 Participants
Phase 2 N=28 Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Acute Myeloid Leukemia
Primary: Response Rate of Crenolanib Besylate Combination Therapy — 2; 0; 3; 1 Participants
Phase 2 N=16 Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation
Leukemia
Primary: Participants With a Response CR + PR + CRi — 4; 1; 4 Participants
Phase 2 N=60 Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
Acute Myeloid Leukemia
Primary: Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis — 0.93; 0.93; 0.80; 0.93…
Phase 2 N=30 Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients
Acute Myeloid Leukemia
Primary: Number of Patients Who Relapsed — 5; 2; 0; 1 Participants
Phase 3 N=539 Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia · Leukemia
Primary: Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia — 31.9; 15.1 months — p=0.0324
Phase 2 N=56 A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
Acute Myeloid Leukemia With FLT3 Activating Mutations That Has Relapsed or Been Refractory After One or More Prior Therapies
Primary: Response Rate of Patients Receiving Crenolanib Therapy — 8; 3; 4; 1 Participants
Phase 3 N=15 A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
Acute Myeloid Leukemia (AML) · Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Primary: Overall Survival (OS) — 9.82; 9.23; 5.24 months — p=0.523
Phase 3 N=356 A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
Primary: Relapse-free Survival (RFS) — NA; NA months — p=0.0518
Phase 3 N=371 A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
Leukemia, Acute Myeloid (AML)
Primary: Duration of Overall Survival (OS) — 9.3; 5.6 Months — p=0.0004
Phase 2 N=98 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
Acute Myeloid Leukemia (AML) · Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
Primary: Relapse-free Survival (RFS) Per Independent Review Committee (IRC) Adjudication — 24.02; 15.84 Months — p=0.163
Phase 2 N=45 Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Adult Acute Basophilic Leukemia · Adult Acute Eosinophilic Leukemia · Adult Acute Megakaryoblastic Leukemia (M7)
Primary: Complete Response — 45 participants
Phase 2 N=37 Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
Leukemia, Myeloid, Acute
Primary: Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML — 56.5; 33.3; 53.8…
Phase 2 N=16 Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Primary: Clinical Response to Crenolanib With Standard Salvage Chemotherapy — 7; 3; 4; 0 Participants
Phase 2 N=172 Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome · Adult Acute Minimally Differentiated Myeloid Leukemia (M0) · Adult Acute Monoblastic Leukemia (M5a)
Primary: Complete Response Rate — 76; 24 participants
Phase 2 N=84 Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Acute Biphenotypic Leukemia · Acute Myeloid Leukemia · de Novo Myelodysplastic Syndrome
Primary: Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Mitoxantrone — 18 mg/m^2
Phase 2 N=42 Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML
Acute Myeloid Leukemia
Primary: Number of Participants That Achieved Complete Remission — 20 Participants
Phase 2 N=11 Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
Leukemia, Myelomonocytic, Acute
Primary: Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib — 0 percentage of participants
Phase 2 N=11 A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML) · Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Primary: Number of Participants With Dose Limiting Toxicities (DLT) — 0; 2 Participants
Phase 2 N=61 Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia · Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome · Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Primary: 30 Day Survival Rate — 97 percentage of participants
Phase 2 N=50 Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Del(5q) · Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Primary: Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts — 38; 33; 41; 23 Participants
Phase 2 N=34 Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Primary: Proportion of Complete Responses (CR or CRi) During Induction Therapy — 0.618 proportion of participants
Phase 3 N=262 Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia
Primary: Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry — 42; 57; 79; 64 Participants — p=0.035
Phase 1 N=76 A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status
Acute Myeloid Leukemia · Leukemia · Myelodysplastic Syndrome
Primary: Number of Participants With Treatment-Emergent Treatment Related Adverse Events Following Oral Administration of Quizartinib in Participants With Relapsed or Refractory…
Phase 2 N=74 Alvocidib, Cytarabine, and Mitoxantrone in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome · Adult Acute Megakaryoblastic Leukemia (M7) · Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Primary: Complete Response — 24; 29 participants
Phase 2 N=46 Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment
Novo Acute Myeloid Leukemia
Primary: Complete Remission of the Disease — NA; 18; 16; NA Participants