Clinical trials: NPM1 Mutation
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
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, 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.
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.
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 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
ALL, Adult, AML, Adult
A Study of BN104 in the Treatment of Acute Leukemia
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken once daily or twice daily in patients with acute lymphocytic leukemia or acute myeloblastic leukemia.
- Conditions
- ALL, Adult, AML, Adult, Acute Leukaemia, KMT2A Rearrangement
- Trial name
- NCT06052813
- Testing
- BN104 monotherapy, BN104 monotherapy - rp2d
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
Healthy
Сlinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers
A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of ZE63-0302 administered orally in healthy volunteers.
- Trial name
- NCT06780124
- Where
- Australia
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Eilean Therapeutics
Leukemia, Myeloid, Acute
MB-dNPM1-TCR.1 in Relapsed/Refractory AML
The goal of this Phase I/II, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR)…
- Trial name
- NCT06424340
- Testing
- MB-dNPM1-TCR.1
- Where
- Netherlands
- Volunteers
- 29 people
- Sponsor
- Miltenyi Biomedicine GmbH
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia
- Trial name
- AUGMENT-101 (NCT04065399)
- Testing
- revumenib, cobicistat
- Where
- 57 sites in United States, Australia and 9 more
- Volunteers
- 447 people
- Sponsor
- Syndax Pharmaceuticals
Acute Myeloid Leukemia (AML)
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations.
- Trial name
- NCT07007312
- Testing
- Ziftomenib, Venetoclax, Azacitidine (AZA)
- Where
- 136 sites in United States, Australia and 15 more
- Volunteers
- 1,300 people
- Sponsor
- Kura Oncology, Inc.
Acute Myeloid Leukemia (AML)
A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
This is the first study to administer ziftomenib to Japanese patients. In this study, the efficacy, safety, and pharmacokinetics of ziftomenib will be evaluated in patients with relapsed or refractory NPM1-mutated acute myeloid…
- Trial name
- NCT07623616
- Testing
- ziftomenib
- Where
- 20 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Relapsed/Refractory Leukemias, Acute Lymphoblastic Leukemia
A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia
The purpose of this study is to determine the safety and tolerability of revumenib when given in combination with 2 different chemotherapy regimens in participants with relapsed/refractory acute leukemias harboring KMT2A…
- Conditions
- Relapsed/Refractory Leukemias, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Mixed Phenotype Acute Leukemia
- Trial name
- NCT05326516
- Testing
- Revumenib, Chemotherapy Regimen 1, Chemotherapy Regimen 2
- Where
- 11 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Syndax Pharmaceuticals
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Mixed-Phenotype Leukemia, Cancer
- Trial name
- NCT05153330
- Testing
- BMF-219
- Where
- 41 sites in United States, Greece and 3 more
- Volunteers
- 55 people
- Sponsor
- Biomea Fusion Inc.
Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute
A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)
A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia.
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute, Multiple Myeloma, Myelodysplastic Syndromes
- Trial name
- NCT04988555
- Testing
- Enzomenib, azoles, Venetoclax
- Where
- 104 sites in United States, Belgium and 10 more
- Volunteers
- 606 people
- Sponsor
- Sumitomo Pharma America, Inc.
AML (Acute Myeloid Leukemia)
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
The goal of this study is to evaluate the safety of CHM-029, an investigational oral medicine, and to evaluate its activity in treating certain types of acute myeloid leukemia (AML) in adults.
- Trial name
- NCT07751991
- Testing
- CHM-029
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Charm Therapeutics