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ClinicalTrials.gov 02/15/2019 11:27
Conditions : Acute Myeloid Leukemia; Myelodysplastic Syndrome With Excess Blasts-2 Interventions : Drug: AG-120; Drug: Placebo for AG-120; Drug: AG-221; Drug: Placebo for AG-221 Sponsors : Stichting Hemato-Oncologie voor Volwassenen Nederland; Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG) Not yet recruiting.
ClinicalTrials.gov 02/15/2019 11:27
Supportive care including blood product transfusions, antiemetic medications, antiviral and antifungal medications, growth factor support, tumor lysis syndrome prophylaxis, or empiric antibiotics may be used at the clinical discretion of the provider.
Tisagenlecleucel (Kymriah; Novartis Pharmaceuticals) is a CD19-directed genetically modified autologous T-cell immunotherapy. On August 30, 2017, the FDA approved tisagenlecleucel for treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory in second or later relapse. Approval was based on the complete remission (CR) rate, durability of CR, and minimal residual disease (MRD) <0.01% in a cohort of 63 children and young adults with relapsed or refractory ALL treated on a single-arm trial (CCTL019B2202). Treatment consisted of fludarabine and cyclophosphamide followed 2 to 14 days later by a single dose of tisagenlecleucel. The CR rate was 63% (95% confidence interval, 50%–75%), an.

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