Floatz Rating
BB67/100
Confidence
Indicative
Sponsor
Children's Oncology Group
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
70High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07498465CT.gov A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia | — | Withdrawn | — | — | — |
NCT07562568CT.gov SHR2554/AZA + Overlapped TBF for High-risk/Relapsed Leukemia/MDS | — | Not Yet Recruiting | — | — | — |
NCT05521087CT.gov A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias | — | Withdrawn | — | — | — |
NCT07059975CT.gov UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML | — | Recruiting | — | — | — |
NCT07108530CT.gov Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study | — | Recruiting | — | — | — |
NCT06869265CT.gov Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT06816134CT.gov Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia | — | Recruiting | — | — | — |
NCT06128070CT.gov Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT06177067CT.gov Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT05761171CT.gov A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia | — | Active Not Recruiting | — | — | — |
Show 49 more trialsShow fewer
NCT05320380CT.gov A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat | — | Withdrawn | — | — | — |
NCT05457556CT.gov Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome | — | Active Not Recruiting | — | — | — |
NCT05476770CT.gov Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies | — | Recruiting | — | — | — |
NCT04898894CT.gov Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT04752163CT.gov DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia | — | Terminated | — | — | — |
NCT04095858CT.gov Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005) | — | Terminated | — | — | — |
NCT04501120CT.gov Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML | — | Recruiting | — | — | — |
NCT04293562CT.gov A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations | — | Recruiting | — | — | — |
NCT04029688CT.gov A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors | — | Terminated | — | — | — |
NCT03970096CT.gov Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) | — | Recruiting | — | — | — |
NCT03860844CT.gov Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT03813147CT.gov Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT03793478CT.gov Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood | — | Active Not Recruiting | — | — | — |
NCT03194932CT.gov Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage | — | Completed | — | — | — |
NCT03164057CT.gov A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT02661035CT.gov Allo HSCT Using RIC for Hematological Diseases | — | Completed | — | — | — |
NCT02676323CT.gov Panobinostat With Fludarabine and Cytarabine for Treatment of Children With Acute Myeloid Leukemia or Myelodysplastic Syndrome | — | Terminated | — | — | — |
NCT03071276CT.gov Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT02779283CT.gov Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT02433483CT.gov Microtransplantation to Treat Refractory or Relapsed Hematologic Malignancies in Younger Patients | — | Terminated | — | — | — |
NCT02419755CT.gov Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies | — | Terminated | — | — | — |
NCT02270788CT.gov Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies | — | Completed | — | — | — |
NCT02220985CT.gov Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD | — | Completed | — | — | — |
NCT02416388CT.gov Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR | — | Recruiting | — | — | — |
NCT02328755CT.gov Peginterferon Alfa-2a to Enhance Anti-leukemic Responses After Allogeneic Transplantation in Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02212561CT.gov Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT01858740CT.gov Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children | — | Completed | — | — | — |
NCT02605460CT.gov Chemo Sensitization Before Hematopoietic Stem Cell Transplantation in Patients With Acute Leukemia in Complete Remission | — | Unknown | — | — | — |
NCT01789255CT.gov Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies | — | Completed | — | — | — |
NCT01773395CT.gov GVAX vs. Placebo for MDS/AML After Allo HSCT | — | Terminated | — | — | — |
NCT01685411CT.gov Busulfan and Cyclophosphamide Followed By ALLO BMT | — | Terminated | — | — | — |
NCT01751997CT.gov Family-mismatched/Haploidentical Donors Versus Matched Unrelated Donors | — | Completed | — | — | — |
NCT01766375CT.gov the Effects and Safety of Idarubicin-strengthened Pretreatment Program and Conventional Busulfan Cyclophosphamide Pretreatment Program on High-risk Acute Myeloid Leukemia Patient | — | Unknown | — | — | — |
NCT01572662CT.gov Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning | — | Completed | — | — | — |
NCT01464359CT.gov T-Cell Depleted Double UCB for Refractory AML | — | Terminated | — | — | — |
NCT01564277CT.gov Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies | — | Terminated | — | — | — |
NCT01187810CT.gov Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL | — | Terminated | — | — | — |
NCT01158885CT.gov Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia | — | Terminated | — | — | — |
NCT01168219CT.gov Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00860574CT.gov Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT00489203CT.gov Beclomethasone Dipropionate in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer | — | Completed | — | — | — |
NCT00406393CT.gov Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402) | — | Completed | — | — | — |
NCT00458250CT.gov Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H | — | Completed | — | — | — |
NCT00669890CT.gov Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML | — | Terminated | — | — | — |
NCT00516152CT.gov Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT | — | Completed | — | — | — |
NCT00136084CT.gov Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia | — | Completed | — | — | — |
NCT00962767CT.gov Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission | — | Completed | — | — | — |
NCT00186966CT.gov Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00636909CT.gov Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Methotrexate (this asset) | Children's Oncology Group | P3 | BB · 67 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Methotrexate
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Adult Acute Lymphoblastic Leukemia | — | P4 | BBB · 77 |
| B-Cell Childhood Acute Lymphoblastic Leukemia | — | P3 | BBB · 76 |
| Acute Promyelocytic Leukemia | — | P3 | BBB · 73 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Methotrexate in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 13, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/methotrexate-acute-myeloid-leukemia
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