A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (Sequential High Dose Cytosine Arabinoside and Mitoxantrone) Versus Standard Double Induction for Initial Chemotherapy of Adult Patients With Acute Myeloid Leukemia (AMLCG 2008)

NCT01382147 Phase 3 COMPLETED

Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.

Details

Lead sponsor	Prof. Dr. Wolfgang Hiddemann
Phase	Phase 3
Status	COMPLETED
Enrolment	396
Start date	2009-07-01
Completion	2017-07-05

Conditions

• Acute Myeloid Leukemia

Interventions

• Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

Primary outcomes

• Overall response rate, aiming at a 15% increase in the CR/PR rate by S-HAM induction versus conventional double induction [TAD - HAM for younger patients, HAM (- HAM) for elderly patients]. — 8 years

Countries

Germany