A study for the treatment of patients with leukemic cells in their bone marrow.

• Conditions: patients = 66 years.with a confirmed diagnosis of o AML (not APL) (see appendix A) or o refractory anemia with excess of blasts (RAEB) with an IPSS score = 1.5 ORPatients of any age = 18 years with a confirmed diagnosis of o AML with very poor risk AML; MedDRA version: 15.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.1Level: LLTClassification code 10037803Term: RAEBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-013094-17-NL
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-18
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Patients eligible for standard chemotherapy.
- Patients = 66 years.with a cytopathologically confirmed diagnosis according WHO classification of
o AML (not APL) (see appendix A) or
o refractory anemia with excess of blasts (RAEB) with an IPSS score = 1.5
OR
- Patients of any age = 18 years with cytopathologically confirmed diagnosis according WHO classification of
o AML with very poor risk AML
- Subjects with secondary AML progressing from antecedent (at least 4 months
duration) myelodysplasia are also eligible.
- SGOT (AST) and SGPT (ALT) <= 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
- Total serum bilirubin level <= 1.5 x the ULN at the laboratory where the analysis was
performed.
- Serum creatinine concentration <= 1.5 x the ULN at the laboratory where the
analysis was performed.
- WHO performance status = 2
- Written informed consent.
- Female patients of childbearing potential must have a negative serum pregnancy
test within 2 weeks prior to enrollment.
- Male and female patients must use an effective contraceptive method during the
study and for a minimum of 6 months after study treatment.(see protocol appendix J for more information and specific requirements)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 230

Exclusion Criteria

-Acute promyelocytic leukemia
- Patients previously treated for AML (any antileukemic therapy including
investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is
allowed
- Past or current history (within the last 2 years prior to randomization) of
malignancies except for the indication under this study and curatively treated:
- Basal and squamous cell carcinoma of the skin
- in situ carcinoma of the cervix
- Blast crisis of chronic myeloid leukemia
- Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular
accidents (= 6 months prior to randomization), myocardial infarction (= 6 months
prior to randomization), unstable angina, New York Heart Association (NYHA) grade
II or greater congestive heart failure,
- Patients with a history of non-compliance to medical regimens or who are
considered unreliable with respect to compliance
- Patients with any serious concomitant medical condition which could, in the opinion
of the investigator, compromise participation in the study.
- Patients who have senile dementia, mental impairment or any other psychiatric
disorder that prohibits the patient from understanding and giving informed consent.
- Pregnant or lactating patients.
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified