Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

Phase 2 Completed 47 enrolled Swiss Cancer Institute

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.

Timeline

Start: 2008-07
Primary completion: 2010-01
Completion: 2012-11

Outcome

Missed primary endpoint

paper although the primary objective was not reached. PMID 23547838 ↗

Publications

Results Passweg JR, Pabst T, Blum S, Bargetzi M, Li Q, Heim D, Stussi G, Gregor M, Leoncini L, Meyer-Monard S, Brauchli P, Chalandon Y; Swiss Group for Clinical Cancer Research (SAKK). Azacytidine for acute myeloid leukemia in elderly or frail patients: a phase II trial (SAKK 30/07). Leuk Lymphoma. 2014 Jan;55(1):87-91. doi: 10.3109/10428194.2013.790540. Epub 2013 May 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacytidine	Other / unclassified	100 mg/m2	Subcutaneous