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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

Ibrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma

Phase 2
Active, not recruiting
Conditions
Mantle Cell Lymphoma
Pleomorphic Variant Mantle Cell Lymphoma
Blastoid Variant Mantle Cell Lymphoma
Interventions
First Posted Date
2015-04-28
Last Posted Date
2024-12-19
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
131
Registration Number
NCT02427620
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia

Phase 2
Terminated
Conditions
Recurrent B Acute Lymphoblastic Leukemia
Refractory B Acute Lymphoblastic Leukemia
Recurrent Ph-Like Acute Lymphoblastic Leukemia
Refractory Ph-Like Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2015-04-20
Last Posted Date
2024-05-08
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
11
Registration Number
NCT02420717
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies

Phase 2
Terminated
Conditions
Acute Lymphoid Leukemia
Acute Myeloid Leukemia
Mixed Lineage Acute Leukemia
Interventions
First Posted Date
2015-04-17
Last Posted Date
2018-03-07
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
12
Registration Number
NCT02419755
Locations
🇺🇸

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

Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

First Posted Date
2015-04-17
Last Posted Date
2018-06-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
1
Registration Number
NCT02419469
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

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

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia (AML)
Interventions
First Posted Date
2015-04-15
Last Posted Date
2024-08-07
Lead Sponsor
University Hospital, Angers
Target Recruit Count
3100
Registration Number
NCT02416388
Locations
🇫🇷

CH Amiens Hôpital Sud, Amiens, France

🇫🇷

CHU Angers, Angers, France

🇫🇷

CH Victor Dupouy, Argenteuil, France

and more 53 locations

Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator

Not Applicable
Terminated
Conditions
Inflammatory Bowel Disease
Ulcerative Colitis
Crohn's Disease
Interventions
First Posted Date
2015-04-09
Last Posted Date
2019-11-04
Lead Sponsor
Indiana University
Target Recruit Count
3
Registration Number
NCT02413047
Locations
🇺🇸

Indiana University Hospital, Indianapolis, Indiana, United States

Chemotherapy Before Surgery in Treating Patients With High Grade Upper Urinary Tract Cancer

Phase 2
Completed
Conditions
High Grade Upper Tract Urothelial Carcinoma
Interventions
First Posted Date
2015-04-09
Last Posted Date
2023-07-10
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
36
Registration Number
NCT02412670
Locations
🇺🇸

Illinois CancerCare-Canton, Canton, Illinois, United States

🇺🇸

Illinois CancerCare-Carthage, Carthage, Illinois, United States

🇺🇸

Illinois CancerCare-Eureka, Eureka, Illinois, United States

and more 131 locations

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Phase 3
Completed
Conditions
Leukemia, Acute Lymphoblastic
Interventions
First Posted Date
2015-03-20
Last Posted Date
2024-05-29
Lead Sponsor
Amgen
Target Recruit Count
111
Registration Number
NCT02393859
Locations
🇬🇧

Research Site, Sutton, United Kingdom

Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2015-03-19
Last Posted Date
2019-02-05
Lead Sponsor
Takeda
Target Recruit Count
7
Registration Number
NCT02393378

Methotrexate and Cytosine in Adult Langerhans Cell Histiocytosis

Phase 2
Completed
Conditions
Langerhans Cell Histiocytosis
Interventions
First Posted Date
2015-03-17
Last Posted Date
2018-09-12
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
43
Registration Number
NCT02389400
Locations
🇨🇳

Peking union medical college hospital, Beijing, China

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