PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)
55 Years
N/A
Both
Acute Lymphoblastic Leukemia
Trial Information
PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day IV for 5 days (-5 to -1).
Supplementary treatment: hydration minimum 2000 ml/day, allopurinol 300 mg / day, gastric
protection (as center), daily monitoring of blood glucose, daily monitoring of renal
function. Intrathecal treatment (diagnosis and prophylactic) day -5: 12 mg were administered
intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS
involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition
of CNS involvement by LAL (and its therapeutic consequences) based on morphological
observation of blasts in CSF cytocentrifuge.
Remission induction:
Tolerance prephase period can be used to establish the final indication of treatment
(standard protocol or frail patients). Day 0 is free of treatment and is considered as +1
the first day of induction. The total duration of the induction is 30 days, consists of two
phases (Phase I, days +1 to +14 and phase II, days +15 to +30). Mandatory testing is
considered counting the percentage of blasts in peripheral blood +8 day of induction, a
myelogram to day +14 to assess early response and a day +35 to assess the complete remission
(days +1 to +14)
- Vincristine (VCR) 1 mg (absolute dose) IV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) IV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 IV, 8 to 11
days +15 to +30)
- cyclophosphamide (CFM): 300 mg / m 2 iV in 1 hour 15 to 17. (3 total doses).
- Cytarabine (ARAC): 60 mg / m 2 iV in 1 hour 16 to 19, 23 to 26. (8 total doses).
- Vincristine (VCR) 1 mg (absolute dose) iV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) iV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 iV, 8 to 11
Consolidation:
Cycles 1, 3, 5 MTX: 1,000 mg/m2, IV infusion of 24 hours day 1 L-ASA. 10,000 IU / m 2 IV or
IM Day 2 Cycles 2, 4, 6 ARAC: 1,000 mg/m2, IV in 3 hours on days 1, 3 and 5
Inclusion Criteria:
Adults over 55 years diagnosed with ALL with chromosome Ph 'negative and naïve
Exclusion Criteria:
1. L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of
Burkitt type (t [8, 14], t [2, 8], t [8, 22]).
2. Biphenotypic acute leukemias and bilinear
3. Acute undifferentiated leukemia
The criteria for exclusion from treatment (but not patient record) any of the
following:
4. Patients with a history of severe and uncontrolled disease, including:
- Coronary artery disease, valvular or hypertensive heart disease.
- Chronic liver disease (active viral or alcoholic).
- Chronic respiratory failure.
- Renal failure not due to the ALL.
- Serious neurological disorder not due to the ALL. f. Improperly controlled
diabetes.
5. General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), not
attributable to the LAL.
6. LAL chromosome Ph 'positive (must register even if you follow a specific protocol).
7. Lack of consent by the patient to use their medical records.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy in terms of response rate
Outcome Time Frame:
5 years
Safety Issue:
No
Authority:
Spain: Ministry of Health
Study ID:
LAL-07OLD
NCT ID:
NCT01366898
Start Date:
May 2010
Completion Date:
December 2013
Related Keywords:
- Acute Lymphoblastic Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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