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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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].

Outcome Time Frame:

8 years

Safety Issue:

Yes

Principal Investigator

Wolfgang Hiddemann, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital of the University of Munich

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2007-003103-12

NCT ID:

NCT01382147

Start Date:

July 2009

Completion Date:

July 2016

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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