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| ID | DOID:0080684 |
| Name | diffuse midline glioma, H3 K27M-mutant |
| Definition | A histone mutated tumor that is characterized by the presence of histone H3 K27M mutation located throughout the midline structures of the central nervous system. |
| Source | DiseaseOntology.org |
| Alt Ids | |
| Path | disease disease of cellular proliferation cancer cell type cancer high grade glioma histone mutated tumor diffuse midline glioma, H3 K27M-mutant |
| Molecular Profile | Therapy | Indication/Tumor Type | Response Type | Profile Response Detail |
|---|---|---|---|---|
| PIK3CA E545K | Trametinib | diffuse midline glioma, H3 K27M-mutant | sensitive | detail... |
| FGFR1 N546K | Alpelisib | diffuse midline glioma, H3 K27M-mutant | sensitive | detail... |
| FGFR1 N546K | Infigratinib | diffuse midline glioma, H3 K27M-mutant | sensitive | detail... |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04099797 | Phase I | C7R-GD2.CAR-T cells Cyclophosphamide + Fludarabine | C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B) | Recruiting | USA | 0 |
| NCT04655404 | Phase I | Larotrectinib | A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma with NTRK Fusion | Recruiting | USA | DEU | CAN | AUS | 0 |
| NCT04732065 | Phase I | ONC206 | ONC206 for Treatment of Newly Diagnosed or Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant Brain Tumors (PNOC 023) | Recruiting | USA | CHE | 0 |
| NCT04804709 | Phase I | Panobinostat | Non-Invasive Focused Ultrasound (FUS) With Oral Panobinostat in Children With Progressive Diffuse Midline Glioma (DMG) | Terminated | USA | 0 |
| NCT04808245 | Phase I | Atezolizumab + H3K27M peptide vaccine + Imiquimod | A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas (INTERCEPT-H3) | Active, not recruiting | DEU | 0 |
| NCT04870944 | Phase Ib/II | CBL0137 | CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma | Recruiting | USA | AUS | 0 |
| NCT04908176 | Phase I | Avapritinib + Midazolam | A Drug-drug Interaction Study of Avapritinib and Midazolam | Completed | USA | 0 |
| NCT04943848 | Phase I | rHSC-DIPGVax Balstilimab + rHSC-DIPGVax Balstilimab + rHSC-DIPGVax + Zalifrelimab | rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG | Recruiting | USA | 0 |
| NCT04978727 | Phase I | SurVaxM | A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma | Active, not recruiting | USA | CAN | 0 |
| NCT05004116 | Phase Ib/II | Irinotecan + Repotrectinib + Temozolomide | A Study of Repotrectinib in Combination with Chemotherapy in Children and Young Adults with Solid Tumor Cancer | Recruiting | USA | 0 |
| NCT05009992 | Phase II | Dordaviprone + GDC-0084 Dordaviprone + Panobinostat | Combination Therapy for the Treatment of Diffuse Midline Gliomas | Recruiting | USA | NZL | NLD | ISR | CHE | AUS | 0 |
| NCT05081180 | Phase I | Avelumab + Lenvatinib | Study of Avelumab in Combination With Lenvatinib for Children With Primary CNS Tumors | Active, not recruiting | FRA | DEU | CAN | 1 |
| NCT05096481 | Phase II | PEP-CMV + Temozolomide | PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma | Recruiting | USA | 0 |
| NCT05099003 | Phase Ib/II | Selinexor | A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG) | Recruiting | USA | NZL | CAN | AUS | 0 |
| NCT05135975 | Phase II | Cabozantinib | A Study of Cabozantinib As a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors | Recruiting | USA | 0 |
| NCT05429502 | Phase Ib/II | Ribociclib + Temozolomide + Topotecan | Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors | Terminated | USA | ITA | GBR | DEU | 0 |
| NCT05476939 | Phase III | Everolimus Dordaviprone | Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 (BIOMEDE 2) | Recruiting | SWE | FRA | ESP | DNK | 0 |
| NCT05478837 | Phase I | Cyclophosphamide + Fludarabine KIND T cells | Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma (PNOC018) | Recruiting | USA | 0 |
| NCT05500508 | Phase Ib/II | AMXT1501 + Eflornithine | Oral AMXT 1501 Dicaprate in Combination With IV DFMO | Terminated | USA | AUS | 0 |
| NCT05518838 | Expanded access | OKN-007 | Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered | No longer available | USA | 0 |
| NCT05544526 | Phase I | GD2 CAR T cells | CAR T Cells to Target GD2 for DMG (CARMIGO) | Recruiting | GBR | 0 |
| NCT05580562 | Phase III | Dordaviprone | ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) (ACTION) | Recruiting | USA | NLD | ITA | ISR | GBR | ESP | DNK | DEU | CHE | CAN | BRA | AUT | AUS | ARG | 4 |
| NCT05768880 | Phase I | SC-CAR4BRAIN | Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors | Active, not recruiting | USA | 0 |
| NCT05835687 | Phase I | B7-H3 CAR-T cells | Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors | Recruiting | USA | 0 |
| NCT05843253 | Phase II | Ribociclib + Temozolomide Everolimus + Ribociclib | Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant | Recruiting | USA | NLD | GBR | DEU | CAN | AUS | 0 |
| NCT06011109 | Phase Ib/II | Bevacizumab APG-157 | Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab | Recruiting | USA | 0 |
| NCT06297512 | Phase II | Doxorubicin + Temozolomide | Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM). | Recruiting | ITA | 0 |
| NCT06305910 | Phase I | CD200AR-L | CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults | Recruiting | USA | 0 |
| NCT06413706 | Phase II | Abemaciclib + Temozolomide Temozolomide | A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy | Recruiting | USA | ROU | NLD | ITA | FRA | ESP | DNK | BEL | AUS | 1 |
| NCT06521567 | Phase Ib/II | Cobolimab + Dostarlimab-gxly | A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer | Active, not recruiting | USA | ITA | FRA | ESP | DNK | CZE | 0 |
| NCT06624371 | Phase I | Atovaquone | Atovaquone Combined with Radiation in Children with Malignant Brain Tumors (AflacBT2303) | Recruiting | USA | 0 |
| NCT06639607 | Phase Ib/II | Nivolumab + PEP-CMV + Temozolomide | PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma (PRiME II) | Not yet recruiting | USA | 0 |
| NCT06838676 | Phase II | ACT001 | ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas | Recruiting | USA | NZL | DEU | CAN | AUS | 0 |
| NCT06894979 | Phase I | AZD1390 | Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma | Recruiting | USA | 0 |
| NCT06896110 | Phase I | Azacitidine + Nivolumab | Intrathecal Azacitidine and Nivolumab in Patients with Recurrent High-grade Glioma | Enrolling by invitation | USA | 0 |
| NCT07076498 | Phase I | M032 | Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation | Not yet recruiting | USA | 0 |
| NCT07223034 | Phase I | lutetium Lu 177 vipivotide tetraxetan + Temozolomide | A Study of 177Lu-PSMA-617 in People With Gliomas | Recruiting | USA | 0 |