A phase II study of induction therapy using idarubicin and infusional high-dose cytarabine for adult patients with de novo untreated acute lymphoblastic leukaemia
- Conditions
- acute lymphoblastic leukaemiaCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12615000631505
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1.A diagnosis of acute lymphoblastic leukaemia by WHO criteria.
2.No prior therapy for ALL
3.Age 20 to 55 years inclusive.
4.Morphological subtypes FAB L1 and L2.
5.Precursor-B immunophenotype, including pre-B (cytoplasmic mu chain expression), and cases with myeloid antigen expression.
6.ECOG performance status 0 to 3 inclusive.
7.Adequate renal (serum creatinine < 150 micromols/L), hepatic (serum bilirubin <2 times upper limit of normal), and cardiac function (normal left ventricular ejection fraction as assessed according to institutional practice).
8.Not known to be seropositive for HIV.
9.Written informed consent to participate in the study.
1.Precursor T or mature B (surface Ig positive) phenotypes
2.Morphological subtype FAB L3
3.Cases which are known to be Philadelphia chromosome positive, or have detectable bcr-abl transcripts by RT-PCR.
4.Past history of cancer, other than non-melanoma skin cancer or carcinoma of cervix in situ.
5.Past history of serious cardiac, pulmonary, hepatic or renal disease.
6.Pregnancy or planned continued breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Induction death rate as measured by the percentage of patients dying[4 weeks after commencing induction therapy ];Incidence of grade 3 and 4 non-haematological toxicities according to the National Cancer Institute Common Terminology Criteria for Adverse Event Reporting vs 2[4 weeks after commencing induction therapy]
- Secondary Outcome Measures
Name Time Method evels of residual disease using PCR-amplification of immunoglobulin gene rearrangements[Days 14 and 28 after induction and after consolidation therapy];Complete remission rate defined as patients meeting all the following criteria:<br>1. Absence of symptoms and signs of leukaemia.<br>2. Neutrophil count > 1.0 x 10^9/ L at least 5 days after ceasing filgrastim.<br>3. Platelet count greater than 100 x 10^9/ L<br>4. Absence of leukaemic cells in the peripheral blood<br>5. Normocellular bone marrow with active haemopoiesis and less than 5 % blasts.<br>[After induction therapy];Leukaemia-free survival[One and two years following induction therapy ]