Clinical trials: Acute Myeloid Leukemia, With NPM1 Mutations
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
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 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 Leukaemia (AML)
Mesenchymal Stem Cells in NPM1 Mutated Low Risk Acute Myeloid Leukemia: a Study of the Tumor Microenvironment and Its Contribution to the Outcome
Acute Myeloid Leukemia (AML) arises from the somatic acquisition of genetic alterations in hematopoietic progenitor or stem cells.
- Trial name
- NCT07379528
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
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
KMT2A-rearranged, NPM1-mutant Refractory or Relapsed AML
Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML
The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory…
- Trial name
- NCT07355335
- Testing
- Ziftomenib, Mezigdomide
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
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
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)
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
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond…
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT06222580
- Testing
- Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Gilteritinib
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Uma Borate
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
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation
This phase I trial studies the side effects and best dose of BSB-2002 when given after cyclophosphamide and fludarabine and tests how well it works in treating NPM1-mutated acute myeloid leukemia (AML) that has come back after a…
- Trial name
- NCT07583303
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- City of Hope Medical Center
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.
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.)
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 (AML)
Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation
This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy.
- Trial name
- NCT01237808
- Testing
- Cytarabine, Etoposide, All-trans retinoic acid (ATRA)
- Where
- 33 sites in Germany
- Volunteers
- 144 people
- Sponsor
- University of Ulm
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.
Acute Myeloid Leukemia, AML, Adult
Revumenib in Combination With 7+3 + Midostaurin in AML
This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a…
- Conditions
- Acute Myeloid Leukemia, AML, Adult, AML With Gene Mutations, AML
- Trial name
- NCT06313437
- Testing
- Revumenib, Midostaurin, Cytarabine
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Richard Stone, MD
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
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.