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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

Inactive Publication Date: 2006-01-11
WYETH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Colony-stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor) increase neutrophil counts, and erythropoietin increases RBC production in 20 to 25% of cases, but not show survival advantage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

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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PUM

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Abstract

Methods of treatment and pharmaceutical combinations are provided for the treatment of acute leukemia, such as acute myelogenous leukemia, and myelodysplastic syndrome. The methods of treatment and pharmaceutical combinations employ an anti-CD33 cytotoxic conjugate in combination with at least one compound selected from the group consisting of an anthracycline and a pyrimidine or purine nucleoside analog. Preferred methods of treatment and pharmaceutical combinations employ gemtuzumab ozogamicin, daunorubicin, and cytarabine.

Description

field of invention [0001] Provided are a treatment method and a drug combination for treating acute leukemia, especially acute myelogenous leukemia and myelodysplastic syndrome. Methods of treatment and drug combinations using anti-CD33 cytotoxic conjugates in combination with at least one compound selected from the group consisting of anthracyclines and pyrimidine or purine nucleoside analogs, in particular gemtuzumab (gemtuzumabozogamicin), dauna cytarabine and cytarabine. Background of the invention [0002] Acute leukemias are generally rapidly progressive leukemias characterized by the replacement of normal bone marrow by blasts derived from malignantly transformed clones of hematopoietic stem cells. There are currently two types of acute leukemia, acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML). ALL is the most prevalent malignancy in children, but also occurs in young adults and has a second, lower peak in adults. AML, also called acute myel...

Claims

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Application Information

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IPC IPC(8): A61K31/44A61K31/53A61K31/70A61K31/445A61K45/06E05F3/00E05F3/10
CPCE05F3/00A61K31/53A61K31/445E05F3/108A61K31/44A61K45/06A61K31/70A61P7/00A61P35/02A61P43/00
Inventor J·M·费恩戈德
Owner WYETH LLC
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