ACTRN12615000631505CompletedPhase 2
A phase II study to evaluate the effect of induction therapy using idarubicin and infusional high-dose cytarabine on mortality rate and haematological toxicity in adult patients with de novo untreated acute lymphoblastic leukaemia
Australasian Leukaemia and Lymphoma Group0 sites20 target enrollmentStarted: June 17, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 20 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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