Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01366898 |
| Other study ID # |
LAL-07OLD |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2007 |
| Est. completion date |
December 2022 |
Study information
| Verified date |
January 2022 |
| Source |
PETHEMA Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The protocol objective is providing adequate treatment and based on broad consensus in
elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that
enables a joint analysis of results strong enough to make conclusions on specific subgroups
of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of
age or associated diseases). Provide results of a treatment to consider standard against
which to compare the results of phase II trials of experimental drugs that undoubtedly will
be activated in the coming years
Description:
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
