Combination therapy for the treatment of acute leukemia and myelodysplastic syndrome
A technology for acute leukemia and syndrome, applied in drug combinations, blood diseases, extracellular fluid diseases, etc., can solve problems such as no survival advantage
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Embodiment 1
[0073] A phase 1 / 2 study combining gemtuzumab with cytarabine and daunorubicin was initiated in the United States to evaluate the safety and efficacy of gemtuzumab as part of a combination therapy for the treatment of AML. Research. From October 2000 to November 2001, patients with relapsed, refractory, or de novo AML entered Phase 1. The established maximum tolerated dose was determined to be cytarabine 100 mg / m 2 / day by continuous infusion on days 1 to 7; daunorubicin 45 mg / m 2 Administer by IV bolus on days 1 to 3; gemtuzumab 6 mg / m 2 , administered by 2-hour infusion on day 4. The phase 2 part of the study began to recruit people in November 2001. It is planned to recruit 45 patients, and 42 patients have been found so far.
[0074] A detailed evaluation of safety and efficacy was performed in 19 patients who were initially treated with this combination induction therapy and followed for at least 28 days. A total of sixteen men and three women were enrolled, with a m...
Embodiment 2
[0079] The feasibility of combining gemtuzumab with intensive chemotherapy for induction and / or consolidation was assessed in a UK safety study of 67 patients prior to the start of the Medical Research Center's AML15 clinical trial. The aim is to combine gemtuzumab with chemotherapy planned in clinical trials, (DAT; daunorubicin, AraC, thioguanine, or DA; daunorubicin, AraC; or FLAG-IDA; fludarabine, AraC, G -CSF, idarubicin) as the first course of treatment. 55 patients used 3mg / m on the first day of chemotherapy 2 Gemtuzumab was used for the first course of treatment. Thirty-three patients received gemtuzumab and DAT. Eight patients received gemtuzumab and DA. Fourteen patients received gemtuzumab and FLAG-Ida. Of the 55 patients treated, 41 (85%) entered complete remission, and the first course of treatment was classified (break down) as follows: (1) DAT=26 / 32; (2) DA=7 / 8; (3) FLAG -Ida=8 / 8. Previously in another clinical trial called MRC AML12, 720 patients were trea...
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