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Methotrexate/Hydrocortisone
Methotrexate inhibits dihydrofolate reductase to suppress cell proliferation, while hydrocortisone provides anti-inflammatory and immunosuppressive effects.
Methotrexate inhibits dihydrofolate reductase to suppress cell proliferation, while hydrocortisone provides anti-inflammatory and immunosuppressive effects. Used for Acute lymphoblastic leukemia (ALL), Graft-versus-host disease (GVHD) prophylaxis in hematopoietic stem cell transplantation.
At a glance
| Generic name | Methotrexate/Hydrocortisone |
|---|---|
| Sponsor | Dana-Farber Cancer Institute |
| Drug class | Antimetabolite + Corticosteroid combination |
| Target | Dihydrofolate reductase (methotrexate); Glucocorticoid receptor (hydrocortisone) |
| Modality | Small molecule |
| Therapeutic area | Oncology, Immunology |
| Phase | Phase 3 |
Mechanism of action
Methotrexate is an antimetabolite that blocks folate metabolism, reducing DNA synthesis and cell division in rapidly proliferating cells. Hydrocortisone is a corticosteroid that suppresses immune responses and inflammation. Together, this combination targets both malignant cell growth and inflammatory/immune-mediated complications, commonly used in hematologic malignancies and graft-versus-host disease (GVHD) prophylaxis.
Approved indications
- Acute lymphoblastic leukemia (ALL)
- Graft-versus-host disease (GVHD) prophylaxis in hematopoietic stem cell transplantation
Common side effects
- Myelosuppression
- Mucositis
- Hepatotoxicity
- Nephrotoxicity
- Immunosuppression/Infection
- Hyperglycemia
- Hypertension
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- 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 (PHASE1)
- A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) (PHASE3)
- Venetoclax Basket Trial for High Risk Hematologic Malignancies (PHASE1)
- Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy (PHASE3)
- Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia (PHASE1)
- Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Methotrexate/Hydrocortisone CI brief — competitive landscape report
- Methotrexate/Hydrocortisone updates RSS · CI watch RSS
- Dana-Farber Cancer Institute portfolio CI