Study for patients with leukemic cells in their bone marrow

Phase 1

• Conditions: patients = 66 years with:- a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or- acute leukemia's of ambiguous lineage according to WHO 2008 or- a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R > 4.5; MedDRA version: 19.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: LLTClassification code 10037803Term: RAEBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: 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: EUCTR2014-001876-75-BE
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Patients eligible for standard chemotherapy.
• Patients 66 years and older
• Patients with:
- a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or
- acute leukemia’s of ambiguous lineage according to WHO 2008 or
- a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R > 4.5
• Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
- Serum creatinine =1.0 mg/dL (=88.7 µmol/L); if serum creatinine >1.0 mg/dL (>88.7 µmol/L), then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where the Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine in mg/dL)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
NOTE: if serum creatinine is measured in µmol/L, recalculate it in mg/dL according to the equation: 1 mg/dL = 88.7 µmol/L and use the above mentioned formula.
- Serum bilirubin = 2.5 x upper limit of normal (ULN)
- Aspartate transaminase (AST) = 2.5 x ULN
- Alanine transaminase (ALT) = 2.5 x ULN
- Alkaline phosphatase = 2.5 x ULN
• WHO performance status 0, 1 or 2 (see Appendix F)
• Written informed consent.
• Male and female patients must use an effective contraceptive method if relevant during the study and for a minimum of 6 months after study treatment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
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
• Concurrent history of active malignancy in the two past years prior to diagnosis except for:
- Basal and squamous cell carcinoma of the skin
- in situ carcinoma of the cervix
• Blast crisis of chronic myeloid leukemia
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
• Cardiac dysfunction as defined by:
- Myocardial infarction within the last 6 months of study entry, or
- Reduced left ventricular function with an ejection fraction < 50% ad measured by MUG scan or echocardiogram or
- Unstable angina or
- New York Heart Association (NYHA) grade II or greater congestive heart failure (see Appendix I) or
- Unstable cardiac arrthythmias
• 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.
• Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study & Design

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