This study aims to investigate the safety and efficacy of clofarabine, given in combination with cytarabine and liposomal daunorubicin, in the treatment of children with relapsed/refractory acute myeloid leukemia (AML)
- Conditions
- Relapsed/refractory acute myeloid leukemiaMedDRA version: 14.1Level: LLTClassification code 10066638Term: Acute myeloid leukemia progressionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2009-009457-13-DE
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
• 2nd relapse of AML
• refractory AML in 1st relapse (defined as = 20% blasts in the bone marrow after the 1st course of re-induction therapy according to the AML 2001/01 protocol)
• 1st early relapse (relapse within one year from initial diagnosis) of AML (only when the Relapsed AML 2001/01 study is closed)
• = 18 years old at initial diagnosis
• Lansky play score > 60; or Karnofsky performance status > 60
• Life expectancy > 6 weeks
• Calculated creatinine clearance = 90 ml/min/1.73m2 as calculated by the Schwartz formula for estimated glomerular filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height (cm)/serum creatinine (mg/dl). k is a proportionality constant which varies with age and is a function of urinary creatinine excretion per unit of body size; 0.45 up to 12 months of age; 0.55 children and adolescent girls; and 0.70 adolescent boys.
• Liver function:
Serum bilirubin =1.5 × upper limit of normal (ULN)
Aspartate transaminase (AST)/alanine transaminase (ALT) >2.5 × ULN
Alkaline phosphatase > 2.5 × ULN
• Able to comply with scheduled follow-up and with management of toxicity.
• For female patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study
• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
• Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
Are the trial subjects under 18? yes
Number of subjects for this age range: 39
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) no
F.1.3.1 Number of subjects for this age range
• Isolated extramedullary relapse, including isolated CNS-relapse
• Symptomatic CNS leukemia in case of combined relapse
• Relapsed/refractory acute promyelocytic leukemia (APL)
• Relapsed/refractory myeloid leukemia of Down Syndrome (ML DS)
• Other serious illnesses or medical conditions
• Current uncontrolled infection
• Evidence of cardiac dysfunction (shortening fraction below 28%)
• Pregnant or lactating patients
Prior or current history:
• Use of any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy (note: hematological toxicities do not need to be considered since the patient has overt leukemia).
• History of prior veno-occlusive disease (VOD)
• Hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method