Clinical trials: NPM1 Mutation
Acute Myeloid Leukemia, Acute Myeloid Leukemia in Remission
Ziftomenib Maintenance Post Allo-HCT
The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation…
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia in Remission, NPM1 Mutation, KMT2A Rearrangement
- Trial name
- NCT06440135
- Testing
- Ziftomenib
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Massachusetts General Hospital
Leukemia, Myeloid, Acute
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)
The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with…
- Trial name
- cAMeLot-2 (NCT06852222)
- Testing
- Bleximenib, Venetoclax (VEN), Azacitidine (AZA)
- Where
- 266 sites in United States, Australia and 23 more
- Volunteers
- 600 people
- Sponsor
- Janssen Research & Development, LLC
Acute Myeloid Leukemia, NPM1 Mutation
Study on the Efficacy and Safety of VA Regimen Compared to "3+7" Regimen in Newly Diagnosed AML With NPM1 or IDH1/IDH2 Mutations
This prospective, multicenter, randomized, open-label, non-inferiority clinical study aims to compare the efficacy and safety of VA regimen (venetoclax combined with azacitidine) versus conventional "3+7" chemotherapy regimen in…
- Conditions
- Acute Myeloid Leukemia, NPM1 Mutation, IDH1 Mutation, IDH2 Mutation
- Trial name
- NCT07664839
- Testing
- VEN combined with azacitidine, Cytarabine plus Daunorubicin
- Where
- China
- Volunteers
- 148 people
- Sponsor
- Shen yang
Acute Myeloid Leukemia
Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML
This phase II clinical trial evaluates the efficacy and tolerability of the non-intensive treatment with venetoclax and the hypomethylating agent azacitidine as compared to the standard of care chemotherapy plus gemtuzumab…
- Trial name
- VINCENT (NCT05904106)
- Testing
- Venetoclax plus Azacitidine, standard of care chemotherapy plus gemtuzumab ozogamicin
- Where
- 18 sites in Germany
- Volunteers
- 146 people
- Sponsor
- Technische Universität Dresden
AML - Acute Myeloid Leukemia, AML With Mutated NPM1
Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation
The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML). It will evaluate the safety of BSB-2002 and also determine whether it works to prevent relapse of your…
- Conditions
- AML - Acute Myeloid Leukemia, AML With Mutated NPM1, AML, Adult Recurrent
- Trial name
- NCT07566585
- Testing
- SOC+ BSB-2002, SOC+BSB-2002
- Where
- United States
- Sponsor
- BlueSphere Bio, Inc
Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement
A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease
This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute…
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Secondary Acute Myeloid Leukemia
- Trial name
- NCT05886049
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- 23 sites in United States
- Volunteers
- 38 people
- Sponsor
- National Cancer Institute (NCI)
Acute Myeloid Leukemia
Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse.
Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal…
- Trial name
- MOLAM (NCT04931992)
- Testing
- No intervention
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Angers
Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
- Conditions
- Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1
- Trial name
- NCT05735184
- Testing
- Ziftomenib, Venetoclax, Azacitidine
- Where
- 44 sites in United States
- Volunteers
- 420 people
- Sponsor
- Kura Oncology, Inc.
Menin Inhibitors, Acute Leukemia
A Real-world Study on the Efficacy and Safety of Menin Inhibitors as Maintenance After Allo-HSCT
The objective of this observational study is to evaluate the efficacy and safety of menin inhibitor maintenance therapy in patients with acute leukemia who have undergone allogeneic hematopoietic stem cell transplantation…
- Conditions
- Menin Inhibitors, Acute Leukemia, Post Hematopoietic Stem Cell Transplantation, Maintenance Therapy
- Trial name
- NCT07559695
- Where
- China
- Volunteers
- 20 people
- Sponsor
- The First Affiliated Hospital of Soochow University
AML, AML With Mutated NPM1
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA…
- Conditions
- AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar
- Trial name
- NCT06001788
- Testing
- Ziftomenib, Fludarabine, Idarubicin
- Where
- 45 sites in United States, Italy and 1 more
- Volunteers
- 171 people
- Sponsor
- Kura Oncology, Inc.
Menin Inhibitors, Post Hematopoietic Stem Cell Transplantation
Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia
This is a phase 2, open label, single arm trial. This study aims to assess the efficacy and safety of menin inhibitor BN104 as maintenance therapy in patients with acute leukemia harboring specific genetic alterations who have…
- Conditions
- Menin Inhibitors, Post Hematopoietic Stem Cell Transplantation, Maintenance Therapy, Acute Leukemia
- Trial name
- NCT07101497
- Testing
- BN104 monotherapy
- Where
- China
- Volunteers
- 60 people
- Sponsor
- The First Affiliated Hospital of Soochow University
NPMc+ AML
Oral Arsenic Trioxide for NPM1-mutated AML
A prospective open-label phase 2 study will be designed to assess the efficacy of oral arsenic trioxide plus azacitidine in preventing relapses in patients with NPM1-mutant AML.
- Trial name
- NCT04689815
- Testing
- Oral Arsenic Trioxide Formulation
- Where
- Hong Kong
- Volunteers
- 50 people
- Sponsor
- The University of Hong Kong
Acute Lymphoblastic Leukemia, With KMT2A Rearrangements, Acute Myeloid Leukemia, With NPM1 Mutations
Expanded Access to Ziftomenib
Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL) with KMT2A rearrangements, or Acute Myeloid Leukemia (AML), with KMT2A…
- Conditions
- Acute Lymphoblastic Leukemia, With KMT2A Rearrangements, Acute Myeloid Leukemia, With NPM1 Mutations, Acute Myeloid Leukemia, With KMT2A Rearrangements
- Trial name
- NCT05738538
- Testing
- ziftomenib
- Sponsor
- Kura Oncology, Inc.
Acute Myeloid Leukemia
Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation
Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation. Before Amendment No.
- Trial name
- NCT00893399
- Testing
- Gemtuzumab Ozogamicin (Mylotarg), standard chemotherapy
- Where
- 60 sites in Austria, Germany
- Volunteers
- 600 people
- Sponsor
- University of Ulm
Acute Myeloid Leukemia, NPM1 Mutation
Observational Study on APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions
This is a multicenter observational study with a retrospective and a prospective cohort investigating clinically and biologically the APL-like subset as a potential predictor of coagulopathy and susceptibility to early vascular…
- Trial name
- ACTIVATE (NCT07080970)
- Testing
- observation of incidence of early vascular events
- Where
- Italy
- Volunteers
- 220 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
This phase II trial studies how well arsenic trioxide works in treating patients with relapsed or refractory acute myeloid leukemia.
- Conditions
- Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b)
- Trial name
- NCT01835288
- Testing
- arsenic trioxide, laboratory biomarker analysis
- Sponsor
- Stanford University
Acute Myeloid Leukemias
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone.
- Trial name
- REVEAL-ND NPM1 (NCT07211958)
- Testing
- Revumenib, Intensive Chemotherapy Regimen
- Where
- 173 sites in United States, Argentina and 21 more
- Volunteers
- 468 people
- Sponsor
- Syndax Pharmaceuticals
Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome
Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory…
- Trial name
- RIVER-52 (NCT06268574)
- Testing
- RVU120
- Where
- 41 sites in France, Italy and 2 more
- Volunteers
- 62 people
- Sponsor
- Ryvu Therapeutics SA
Nucleophosmin 1-mutated Acute Myeloid Leukemia
Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as…
- Trial name
- NCT05020665
- Testing
- Entospletinib, Cytarabine, Anthracycline
- Where
- 83 sites in United States, Brazil and 10 more
- Volunteers
- 15 people
- Sponsor
- Kronos Bio
Acute Leukemia, KMT2A Rearrangements or NPM1 Mutations Acute Leukemia
BY002 IIT Study in R/R Acute Leukemia
This is a single-center, open-label, investigator-initiated phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and preliminary efficacy of the menin inhibitor BY002 in patients with relapsed or refractory acute…
- Trial name
- NCT07270770
- Testing
- BY002
- Where
- China
- Volunteers
- 18 people
- Sponsor
- The First Affiliated Hospital of Soochow University