None listed
Conditions
Brief summary
The primary hypothesis is that an intensive chemotherapy protocol, incorporating high-dose cytarabine and Idarubicin, as originally designed for treatment of Acute Myeloid Leukaemia, when used in the treatment of adults with Acute Lymphoblastic Leukaemia, has acceptable tolerability and safety. The subsidiary hypothesis is that this regimen will result in a greater degree of reduction of the number of leukaemia cells, than conventional treatment.
Interventions
1. Induction chemotherapy (1x 28 day cycle)
a. Cytarabine given as a 2 hour intravenous infusion at a dose of 3 gm/ m2 on day 1, followed by a continuous intravenous infusion beginning 12 hours after commencement of the initial dose for a total of 96 hours at a dose of 1.5 gm/m2 per 24 hours.
b. Idarubicin, given as an intravenous bolus at a dose of 12 mg/m2 on days 1, 2, and 3.
Supportive treatment consisting of Allopurinol 300 mg daily per oral given from day –2 until the white cell count is b
1. Induction chemotherapy (1x 28 day cycle) a. Cytarabine given as a 2 hour intravenous infusion at a dose of 3 gm/ m2 on day 1, followed by a continuous intravenous infusion beginning 12 hours after commencement of the initial dose for a total of 96 hours at a dose of 1.5 gm/m2 per 24 hours. b. Idarubicin, given as an intravenous bolus at a dose of 12 mg/m2 on days 1, 2, and 3. Supportive treatment consisting of Allopurinol 300 mg daily per oral given from day –2 until the white cell count is below 1.0 x 10^9/L, and Fluconazole 200 mg daily orally for 28 days as fungal infection prophylaxis. Filgrastim started on day + 6 at a dose of 5 microgram / kg daily by subcutaneous injection until the post-nadir neutrophil count exceeds 2.0 x 10^9/L. One intrathecal injection of Methotrexate 12 mg given at the start of induction therapy. Induction therapy is 1x 28 day cycle. 2. Post-induction treatment (consolidation 1x 28 day cycle) a. Cytarabine 3 gm/ m2 as an intravenous infusion over 2 hours, followed 12 hours later by a continuous intravenous infusion at a dose of 1.5 gm/m2 per 24 hours for 72 hours. b. Idarubicin, as an intravenous bolus at a dose of 12 mg/ m2 daily on days 1 and 2. Filgrastim from day +5 at a dose of 5 microgram per kg subcutaneously daily until recovery of the neutrophil count to greater than 2.0 x 10^9/L. One injection of intrathecal Methotrexate 12mg given at the start of consolidation therapy. The duration between induction and consolidation is 28 to 35 days. Following consolidation with cytarabine and Idarubicin, a further course of therapy was given using high dose intravenous Methotrexate, as soon as practical after day 28 from the start of consolidation therapy. This consists of 3 g/m2 for 2 courses 14 days apart.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 55 Years
Healthy volunteers
No
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.
Outcome results
None listed