Clinical trials: NPM1 Mutation
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.)
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, Acute Myeloid Leukemia, in Relapse
Venetoclax and Azacitidine for the Management of Molecular Relapse/Progression in Adult NPM1-mutated Acute Myeloid Leukemia
This is a phase 2, non-randomized, interventional, open-label, multicenter trial evaluating the efficacy of VEN-AZA as a bridge-to-transplant therapy in chemotherapy-treated adult NPM1mut AML patients who experience molecular…
- Conditions
- Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse, NPM1 Mutation
- Trial name
- NCT04867928
- Testing
- Venetoclax+azacitidine
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Acute Myeloid Leukemia
Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy
This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy.
- Trial name
- NCT06930352
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Uma Borate
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 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
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, Adult
Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need.
- Trial name
- NCT06652438
- Testing
- Revumenib
- Where
- 201 sites in United States, Australia and 16 more
- Volunteers
- 448 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
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.
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 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 Leukemia, Acute Leukemia of Ambiguous Lineage
Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant
This phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant.
- Conditions
- Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- Trial name
- NCT06575296
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- City of Hope Medical Center
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
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.
Acute Myeloid Leukemia
Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia
The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes.
- Trial name
- NCT07411586
- Testing
- Ziftomenib, Olutasidenib
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- M.D. Anderson Cancer Center