Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
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|ClinicalTrials.gov Identifier: NCT01366898|
Recruitment Status : Recruiting
First Posted : June 6, 2011
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate||Phase 4|
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.
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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)|
|Actual Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
|Experimental: Chemotherapy||Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate|
- Efficacy in terms of response rate [ Time Frame: 5 years ]
- Efficacy in terms disease free survival [ Time Frame: 5 years ]
- Efficacy in terms of global survival [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366898
|Hospital Germans Trias i Pujol and all Hospital Pethema||Recruiting|
|Badalona, Barcelona, Spain|
|Contact: José Mª Ribera, Dr firstname.lastname@example.org|