Clinical trials: MLL Rearrangement
Relapsed Adult AML, Stem Cell Transplant Complications
Menin-Inhibitor Targeted Maintenance in AML
Revumenib is a first in class oral menin inhibitor that targets a central oncogenic dependency shared across KMT2Ar, NPM1m, and NUP98r AML.
- Conditions
- Relapsed Adult AML, Stem Cell Transplant Complications, Acute Myeloid Leukemia, Transplant-Related Hematologic Malignancy
- Trial name
- NCT07563010
- Testing
- Revumenib
- Volunteers
- 146 people
- Sponsor
- Center for International Blood and Marrow Transplant Research
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
Acute Leukemia of Ambiguous Lineage, B Acute Lymphoblastic Leukemia
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement.
- Conditions
- Acute Leukemia of Ambiguous Lineage, B Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
- Trial name
- NCT02828358
- Testing
- Azacitidine, Biospecimen Collection, Computed Tomography
- Where
- 170 sites in United States, Australia and 2 more
- Volunteers
- 78 people
- Sponsor
- National Cancer Institute (NCI)
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, 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
Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia
Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic…
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia, Higher-risk Myelodysplastic Syndromes
- Trial name
- MOMENTUM (NCT07155226)
- Testing
- AZD3632, Posaconazole
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 85 people
- Sponsor
- AstraZeneca
Acute Myeloid Leukemia
Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement
This phase Ib/II trial studies the side effects and best dose of pinometostat and how well it works with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia and a type of genetic mutation called…
- Trial name
- NCT03724084
- Testing
- Cytarabine, Daunorubicin, Daunorubicin Hydrochloride
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- National Cancer Institute (NCI)
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.)
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), MLL Rearrangement
Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia
The goal of this observational study is to learn about the predict value of leukemia stem cell for acute myeloid leukemia patients with MLL-rearrangement.
- Trial name
- MLL-LSC (NCT07537738)
- Testing
- Detection of leukemia stem cell using multiparameter flow cytometry
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Peking University People's Hospital
Leukemia, Acute Myeloid Leukemia
A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene
A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the…
- Conditions
- Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Leukemias
- Trial name
- NCT02141828
- Testing
- EPZ-5676
- Where
- 9 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Epizyme, Inc.
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 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
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 With t(9;11)(p21.3;q23.3); MLLT3-MLL, Leukemia Cutis
Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement
This phase Ib/II trial studies the side effects and best dose of pinometostat when given together with azacitidine and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), does…
- Conditions
- Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL, Leukemia Cutis, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT03701295
- Testing
- Azacitidine, Pinometostat
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)