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Methotrexate - ClinicalTrials.gov

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Last Updated: 08 August 2022

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Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma

During interim maintenance, Leucovorin rescue was found to have relative safety and efficacy with leucovorin rescue relative to escalating methotrexate with leucovorin rescue and rising pegaspargase. While treating Intermediate and high risk patients with 1200 cgy of prophylactic cranial radiation, it was determined with relative safety and efficacy of withholding radiation in patients with low risk T-cell acute lymphoblastic leukemia. Leucovorin calcium PO is also administered to patients with DS at 48 and 60 hours after each methotrexate dose. Patients with persistent testicular disease or with DS and testicular disease testicular disease receive testicular radiotherapy on days 11-12, 15-19, and 22-26. Patients with normal risk T-LLy received Arm I, and those with high risk T-LLy were randomized between Arm I and Arm II combination chemotherapy. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. Patients with high risk T-LLy were randomized between Arm I and Arm II, with Arm I and Arm II being randomized between Arm I and Arm II. Patients with DS also receive leucovorin calcium PO 48 and 60 hours after each methotrexate IT dose was administered. Each patient with T-LLy has been treated for a year, with some patients suffering T-LLy and three years from the beginning of interim maintenance therapy. On days 22, 22-26, and 29-33, patients with persistent testicular disease, DS, and testicular disease receive testicular radiotherapy. Patients receive vincristine sulfate IV and increasing doses of methotrexate IV on days 1, 11, 21, 31, and 41; pegaspargase* IM or IV over 1-2 hours on days 2, 21, and 41; and methotrexate IT on days 1, 11, 21, 31, 31 and 41; and methotrexate IV on days 1, 11, 21, 31, and 41; and methotrexate IV and 41; and methotrexate IV. Treatment repeats have occurred every 84 days until the total duration of study is two years, including those with T-LLY and those with T-LLY, and three years from the start of interim maintenance therapy. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose. On days 11-12, 15-19, and 22-26, patients with persistent testicular disease or with DS and testicular disease receive testicular radiotherapy. Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose was administered. Every 84 days until the completion of study is two years from the start of interim maintenance therapy and all patients with T-LLy, and all patients with T-LLy, to T-IIIy, and three years after the commencement of interim maintenance therapy. Patients receive HDMTX IV over 24 hours and vincristine sulfate IV on days 1, 29, and 43; mercaptopurine PO on days 1, 15, 29, and 43; and methotrexate IT on days 1, 29, and 29. Patients are also receiving leucovorin calcium IV or PO every 6 hours for 3 doses beginning 42 hours after the introduction of HDMTX. Chronic maintenance therapy begins with interim maintenance therapy, and for those with T-LLY, and 3 years from the beginning of interim maintenance therapy.

Source link: https://clinicaltrials.gov/ct2/show/NCT00408005


Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma

As induction therapy of primary CNS lymphoma, determine the maximum tolerated dose of lenalidomide when given in combination with high dose-methotrexate and rituximab, with or without nivolumab. After initial treatment of primary CNS lymphoma, determine how many patients who will be able to maintain maintenance therapy with lenalidomide and/or nivolumab. Using MRI-based techniques and minimal residual disease of blood and CSF, we can determine the response to therapy and minimal residual disease. Patients are sent rituximab intravenously on day 1, methotrexate IV over 2 hours or orally on day 1, lenalidomide PO daily on days 5-14, and nivolumab IV over 30 minutes on day 14. MAINTENANCE: Patients receive lenalidomide PO daily on days 1-21, and nivolumab IV over 30 minutes on day 1.

Source link: https://clinicaltrials.gov/ct2/show/NCT04609046


Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy

Despite being the only widely accepted therapeutic treatment for active TAO, 20-30 percent of patients may not respond well to corticosteroids. In several studies, the safety of other immunosuppressives in the management of active TAO has been determined, but the effectiveness of periocular administration of corticosteroids for management of active TAO has yet to be determined. In comparison to periocular injections of triamcinolone acetonide, this prospective interventional double-blind controlled trial aims to determine the effectiveness and safety of periocular injections of methotrexate in the treatment of acute, moderate, or severe TAO in the management of chronic, moderate to severe TAO. At day 0, week 3 and week 6, recruited participants will be randomly divided so that one orbit receives three periocular injections of methotrexate and the contralateral orbit receives three periocular injections of triamcinolone acetonide and the contralateral orbit gets three periocular injections of triamcinolone acetonide, while the contralateral orbit receives three periocular injections of triamcinolone acetontine periocular injections periocular injections.

Source link: https://clinicaltrials.gov/ct2/show/NCT05429450


A Dose-escalating Pilot Study of Orelabrutinib in Combination With Rituximab, Methotrexate and Dexamethasone for Newly-diagnosed Primary Central Nervous System Lymphoma

Rituximab 375 mg/m2 intravenous infusion, d1; HD-MTX 3. 5 g/m2 intravenous infusion, d2; HD-MTX 3. 5 g/m2 intravenous infusion, d1; and Dexamethasone during induction therapy : d1-4; Dexamethasone 10-15 mg/m2 intravenous infusion, d1; Rituximab d1; Induction treatment Orelabrutinib will be given 72 hours after MTX infusion or until MTX clearance is cleared. The BOIN algorithm will determine Dose escalation and change in dose matrix. After completion of induction therapy, the CR/CRu patients will be treated with Orelabrutinib as maintenance therapy for up to 1 year or until disease progression, intolerable toxicity, death, informed consent withdrawal, or missing of follow up.

Source link: https://clinicaltrials.gov/ct2/show/NCT05036577


A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

Despite recent treatment with methotrexate, this is a single arm, Open-label, multi-center study to determine the pharmacokinetics, efficacy, and safety of intravenous golimumab in participants with pJIA. The research will consist of three parts: Screening Phase; an Open-label Therapy Phase; Long-Term Extension Phase and Extended Treatment Period; and Extended Treatment Period.

Source link: https://clinicaltrials.gov/ct2/show/NCT02277444


A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis

Participants receiving upadacitinib 15 mg and 30 mg QD will be provided with open-label upadacitinib 15 mg and 30 mg QD, and participants receiving methotrexate will be sent open-label methotrexate starting with Protocol Amendment 6. For all participants, a global analysis will be conducted to compare the primary and secondary efficacy endpoints between the upadacitinib 15 mg QD and 30 mg QD treatment groups against the methotrexate treatment group. Comparing the upadacitinib 7. 5 mg QD, 15 mg QD, and 30 mg QD treatment groups to the methotrexate treatment group for participants enrolled in Japan only would be conducted in a separate Japan sub-study study.

Source link: https://clinicaltrials.gov/ct2/show/NCT02706873


A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy & Safety of MBS2320 in Participants With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response to Methotrexate Alone

MBS2320 in patients with RA in combination with an existing therapy, methotrexate, is the subject of this research. Around 224 people with moderate to severe active RA who have not responded to Methotrexate therapy will be recruited from 45 to 55 locations around the world. Participants in the research will be encouraged to attend the hospital or clinic for regular visits during which they will have planned research findings to measure the study drug's efficacy, tolerability, and safety.

Source link: https://clinicaltrials.gov/ct2/show/NCT05460832


An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications

People with CDs are being tested on Vedolizumab to see people with CDs. This report will examine the endoscopic remission and mucosal healing of gastrointestinal tract of people taking vedolizumab as part of a triple combination therapy with adalimumab and methotrexate. Participants will be given adalimumab 160/80/40 mg Methotrexate 15 mg in a week, 2, 6, 14, and 22, along with adab 160 mg, subcutaneous injection at Week 0, 80 mg, Week 2 and then 40 mg/week thereafter until Week 22, then 40 mg once per week from Week 0, 80 mg up to Week 34. Participants will return to the clinic on multiple visits, as well as a final visit 18 weeks after the last dose of study drug for a safety follow-up study.

Source link: https://clinicaltrials.gov/ct2/show/NCT02764762


A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children <36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue Versus the Same Therapy Without Methotrexate

To determine if infants with high risk primitive neuroectodermal tumors central nervous system tumors with intensive chemotherapy plus high-dose methotrexate and peripheral blood stem cell transplantation results in a higher response rate than the same regimen without methotrexate, we need to determine if treatment of infants with high risk primitive nervous system tumors central nervous system tumors with intense chemotherapy and peripheral blood stem cell transplantation with intensive chemotherapy plus high-dose methotrexate and peripheral nerve system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors results in cytodermal tumors central nervous system tumors with increased response rate than the same regimen without methotrexate and central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system tumors central nervous system To determine whether biologic testing of these tumors will aid in therapeutic stratification within the group of PNETs, and potentially identifying other factors of significance for stratification. To determine if event-free survival and patterns of failure are different between the methotrexate arm and the arm without methotrexate, we'll find out if event-free survival and patterns of failure differ between the methotrexate arm and the arm without methotrexate. Patients are given vincristine IV, high-dose methotrexate IV over four hours on day one; and leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until methotrexate levels are within a safe range. Patients are also receiving G-CSF IV or SC after the completion of chemotherapy and persisting until blood counts return. Patients with a complete response after induction therapy proceed directly to consolidation therapy. CONSOLIDATION THERAPY: Patients who underwent induction therapy, including carboplatin IV over 2 hours and thiotepa IV over 2 hours, on days 1 and 2 in G-CSF IV or SC start on day 5 and then continue until blood counts return to normal. On day 4, patients also received autologous peripheral blood stem cells IV.

Source link: https://clinicaltrials.gov/ct2/show/NCT00336024

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions