Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML)

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vinzenz-Pallotti-Hospital, Innere Abteilung, Bergisch Gladbach, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ara-C, Mitoxantrone, Daunorubicin, Thioguanin

Drug

Chemotherapy

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].

Time frame: 8 years

Sponsors and collaborators

Lead sponsor

Prof. Dr. Wolfgang Hiddemann

Other

Collaborators

Kompetenznetz Leukämien

Registry information

Official study 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

Acronym: AMLCG 2008

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2017
First posted: Jun 27, 2011
Registry last updated: Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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