N/A
55 Years
Both
Acute Lymphoblastic Leukemia Ph Positive
Trial Information
Induction Chemotherapy
- Vincristine (VCR): 1.5 mg/m2 (maximum dose 2 mg) iv days 1, 8, 15 and 22
- daunorubicin (DNR) 45 mg/m2 i.v. days 1, 8, 15 and 22
- Prednisone (PDN): 60 mg/m2 per day, i.v. or p.o., days 1-27
- Imatinib 600 mg p.o. from day 1 until the beginning of the consolidation. Important
Note: The administration of imatinib be initiated as soon as the outcome of cytogenetic
and molecular study, which will be known under normal conditions during prophase
consolidation
Patients should be in RC and shall be a minimum of 2 weeks of finding it. Patients did not
discontinue treatment with imatinib during this period. Minimum counts to start the
consolidation are: neutrophils> 1x109 / L and platelets> 100x109 / L.
- Mercaptopurine (MP) 50 mg/m2, p.o. days 1 to 7, 28 to 35 and 56 to 63
- MTX: 1.5 g/m2, i.v. continuous infusion for 24 hours on days 1, 28 and 56.
- VP-16: 100 mg/m2 every 12 hours, i.v. (1 hour infusion) on days 14 and 42
- ARA-C: 1000 mg/m2 every 12 hours, i.v. (3-hour infusion) days 14-15 and 42-43
- triple intrathecal treatment days 1, 28 and 56
- Imatinib 600 mg / d po, from day 1 to 15 days before the TPH.
During consolidation therapy is recommended in primary prophylaxis with G-CSF or found
neutropenia (<0.5 x109 / L). This factor was administered daily until the neutrophil count
is > 1x109 / L in two consecutive measurements. Alternatively, PEG-filgrastim can be used
(eg 16 and 44), at the discretion of each center
Allogenic THP or Autologous TPH
Inclusion Criteria:
- Patients with Ph (BCR/ABL) positive de novo < 55 years old (it is advisable to
include patients over 55 years LAL07OPH protocol).
- Performance status 0-2 (Appendix B) may include patients with performance status > 2
attributable to LAL.
- Patients without functional impairment of organs: liver function: total bilirubin,
AST, ALT, alfa-GT and alkaline phosphatase less than 3 times the upper limit of
normal laboratory renal function: serum creatinine < 2 mg/dL or clearance creatinine
> 30 ml/min (except renal function attributable to LAL) cardiac function (Appendix B)
normal: ventricular EF > 50%, absence of severe chronic respiratory disease. In the
event that alterations are secondary to the disease is at the discretion of the
investigator to determine if the patient can be included in the trial.
Exclusion Criteria:
- Any other variety of LAL
- Patients with a history of coronary artery disease, valvular or hypertensive heart
disease
- Patients with chronic liver disease
- Patients with chronic respiratory failure
- Renal failure not due to LAL
- Patients with positive HIV status
- No serious neurological abnormalities due to LAL
- Impact on overall severe (grade 3 or 4 of the WHO scale) not attributable to the LAL
- Pregnant or breastfeeding
- initial blast crisis CML
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy in terms of number of complete response
Outcome Time Frame:
1 year
Safety Issue:
No
Authority:
Spain: Ministry of Health
Study ID:
LAL Ph-2008
NCT ID:
NCT01491763
Start Date:
January 2008
Completion Date:
December 2015
Related Keywords:
- Acute Lymphoblastic Leukemia Ph Positive
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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