Overview

This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatment ara-c, mitoxantrone, daunorubicin, thioguanin
Phase phase 3
Sponsor Prof. Dr. Wolfgang Hiddemann
Collaborator Kompetenznetz Leukämien
Start date July 2009
End date August 2012
Trial size 400 participants
Trial identifier NCT01382147, 2007-003103-12

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
ara-c, mitoxantrone, daunorubicin, thioguanin
Chemotherapy
(Active Comparator)
is TAD-9 - HAM for younger patients (with 2 mandatory induction cycles) and HAM (- HAM) for the elderly patients with the second HAM cycle only applied in the case of inadequate blast clearance (> 5%) in the day 16 bone marrow aspirate
ara-c, mitoxantrone, daunorubicin, thioguanin
Chemotherapy

Primary Outcomes

Measure
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].
time frame: 8 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to the WHO classification including patients with secondary AML and AML after preceding hematologic disorders - Age 18 years or older - Informed consent. Before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study. Exclusion Criteria: - Acute promyelocytic leukemia (APL) - Previous or concurrent malignancies other than AML - Previous treatment with colony-stimulating factors, interleukins or interferons - Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®) - Antibody-based or cell-based immunotherapies - Respiratory insufficiency with pO2 <60 mmHg - Heart failure NYHA III° or IV° - Elevated creatinine >2.0 mg/dl - Elevated bilirubin >2.0 mg/dl - Pregnancy or lactation - Females without adequate contraception - Known HIV and/or hepatitis C infection - Severe neurologic or psychiatric disease - Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study - Concerns for subject's compliance with the protocol procedures - Lack of willingness to record and circulate personal disease-related informations defined in the study protocol

Additional Information

Official title 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
Principal investigator Wolfgang Hiddemann, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ludwig-Maximilians - University of Munich.