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Methotrexate

Generic Name
Methotrexate
Brand Names
Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo
Drug Type
Small Molecule
Chemical Formula
C20H22N8O5
CAS Number
59-05-2
Unique Ingredient Identifier
YL5FZ2Y5U1
Background

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division. Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma.

Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments.

Methotrexate was granted FDA approval on 7 December 1953.

Indication

Methotrexate oral solution is indicated for pediatric acute lymphoblastic leukemia and pediatric polyarticular juvenile idiopathic arthritis. Methotrexate injections for subcutaneous use are indicated for severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe, recalcitrant, disabling psoriasis.

Other formulations are indicated to treat gestational choriocarcinoma, chorioadenoma destruens, hydatiform mole, breast cancer, epidermoid cancer of the head and neck, advanced mycosis fungoides, lung cancer, and advanced non-Hodgkin's lymphoma. It is also used in the maintenance of acute lymphocytic leukemia. Methotrexate is also given before treatment with leucovorin to prolong relapse-free survival following surgical removal of a tumour in non-metastatic osteosarcoma.

Associated Conditions
Acute Lymphoblastic Leukemia (ALL), Acute Promyelocytic Leukemia, Bladder Cancer, Breast Cancer, Central Nervous System Lymphoma, Crohn's Disease (CD), Dermatomyositis (DM), Extrauterine Pregnancy, Gestational Trophoblastic Neoplasia, Graft-versus-host Disease (GVHD), Meningeal leukemia, Multiple Sclerosis, Mycosis Fungoides (MF), Non-Hodgkin's Lymphoma (NHL), Non-Hodgkin's Lymphoma, Relapsed, Osteosarcoma, Polyarticular Juvenile Idiopathic Arthritis, Polymyositis, Rheumatoid Arthritis, Soft Tissue Sarcoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Systemic Lupus Erythematosus, Uveitis, Nonleukemic meningeal cancer, Refractory Non-Hodgkin's lymphoma, Refractory Takayasu arteritis, Severe Psoriasis
Associated Therapies
Medically induced abortion

Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

Phase 2
Not yet recruiting
Conditions
Non-Hodgkin Lymphoma
Interventions
First Posted Date
2022-10-17
Last Posted Date
2024-05-13
Lead Sponsor
University of Cologne
Target Recruit Count
20
Registration Number
NCT05583071
Locations
🇩🇪

University of Cologne, Cologne, Germany

A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies

Phase 2
Terminated
Conditions
Myeloid Malignancy
Hematologic Malignancy
Interventions
Drug: Ruxolitinib
Drug: Anti-thymocyte globulin (ATG)
Drug: Mesna
Drug: Cyclosporine
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Methotrexate
Radiation: Total Body Irradiation (radiation treatment)
Drug: Busulfan
Drug: Bone marrow infusion
Drug: Thiotepa
First Posted Date
2022-10-14
Last Posted Date
2024-07-10
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
3
Registration Number
NCT05579769
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma

Phase 2
Recruiting
Conditions
Medulloblastoma
Interventions
Procedure: Surgical resection
Other: Educational and Media Intervention
Other: SOC, Educational and Media Intervention
Procedure: Ommaya/VPS
Drug: Methotrexate
Drug: Cisplatin
Drug: Vincristine
Drug: Cyclophosphamide
Drug: Carboplatin
Drug: Topotecan
Drug: Etoposide
Drug: Pegfilgrastim
Drug: Filgrastim
Radiation: Irradiation
First Posted Date
2022-09-10
Last Posted Date
2024-10-29
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
120
Registration Number
NCT05535166
Locations
🇺🇸

Primary Children's Hospital, Salt Lake City, Utah, United States

🇺🇸

Lucille Packard Children's Hospital at Stanford University, Palo Alto, California, United States

🇺🇸

Orlando Health Arnold Palmer Hospital for Children, Orlando, Florida, United States

and more 7 locations

MAD Study of IA-14069

Phase 1
Recruiting
Conditions
Healthy
Rheumatoid Arthritis
Interventions
Drug: IA-14069
Drug: Placebo
Drug: Methotrexate
First Posted Date
2022-09-09
Last Posted Date
2023-10-13
Lead Sponsor
ILAb Co., Ltd.
Target Recruit Count
75
Registration Number
NCT05533372
Locations
🇺🇸

ICON plc., Lenexa, Kansas, United States

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Conditions
Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2022-08-29
Last Posted Date
2024-12-13
Lead Sponsor
Northside Hospital, Inc.
Target Recruit Count
20
Registration Number
NCT05519579
Locations
🇺🇸

Northside Hospital, Atlanta, Georgia, United States

Modified Zhiwang Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis

Early Phase 1
Recruiting
Conditions
Arthritis, Rheumatoid
Interventions
Drug: Modified Zhiwang Decoction Combined with methotrexate
Drug: Methotrexate
First Posted Date
2022-08-19
Last Posted Date
2023-05-25
Lead Sponsor
Beijing University of Chinese Medicine
Target Recruit Count
150
Registration Number
NCT05508815
Locations
🇨🇳

China-Japan Friendship Hospital, Beijing, China

A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)

Phase 4
Recruiting
Conditions
Mucopolysaccharidosis (MPS)
Hunter Syndrome
Interventions
First Posted Date
2022-08-10
Last Posted Date
2024-12-11
Lead Sponsor
Takeda
Target Recruit Count
5
Registration Number
NCT05494593
Locations
🇺🇸

Children's Hospital and Research Center at Oakland, Oakland, California, United States

🇺🇸

UC Davis Medical Center, Sacramento, California, United States

🇺🇸

Phoenix Childrens Hospital, Phoenix, Arizona, United States

and more 8 locations

Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

Phase 1
Recruiting
Conditions
MDS
Hematologic Malignancy
AML
Lymphoblastic Lymphoma
Lymphoma, T-Cell
BPDCN
Lymphoma, B-Cell
Hodgkin Lymphoma
Mixed Phenotype Acute Leukemia
ALL
Interventions
First Posted Date
2022-07-27
Last Posted Date
2024-12-06
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
54
Registration Number
NCT05476770
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

Children's Hospital Orange County, Orange, California, United States

🇺🇸

UCSF School of Medicine, San Francisco, California, United States

and more 28 locations

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome

Phase 3
Recruiting
Conditions
Mixed Phenotype Acute Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Drug: Busulfan
Drug: Cyclophosphamide
Procedure: Echocardiography
Drug: Fludarabine
Procedure: Haploidentical Hematopoietic Cell Transplantation
Biological: Lapine T-Lymphocyte Immune Globulin
Procedure: Matched Unrelated Donor Hematopoietic Cell Transplantation
Procedure: Lumbar Puncture
Drug: Melphalan
Drug: Methotrexate
Procedure: Multigated Acquisition Scan
Drug: Mycophenolate Mofetil
Procedure: Myeloablative Conditioning
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Biological: Rituximab
Procedure: T-Cell Depletion Therapy
Radiation: Total-Body Irradiation
Drug: Tacrolimus
Drug: Thiotepa
First Posted Date
2022-07-14
Last Posted Date
2024-12-04
Lead Sponsor
Children's Oncology Group
Target Recruit Count
435
Registration Number
NCT05457556
Locations
🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Phoenix Childrens Hospital, Phoenix, Arizona, United States

🇺🇸

Arkansas Children's Hospital, Little Rock, Arkansas, United States

and more 59 locations

A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2022-07-06
Last Posted Date
2023-02-08
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
30
Registration Number
NCT05445440
Locations
🇺🇸

Quotient Sciences Miami, Miami, Florida, United States

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