Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)

Sponsor

PETHEMA Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT01366898

Collaborator

(none)

100

Enrollment

Location

Arm

185.1

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate	Phase 4

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)

Actual Study Start Date :

Jun 30, 2007

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy	Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate

Arm

Intervention/Treatment

Experimental: Chemotherapy

Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate

Outcome Measures

Primary Outcome Measures

Efficacy in terms of response rate [5 years]

Secondary Outcome Measures

Efficacy in terms disease free survival [5 years]
Efficacy in terms of global survival [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults over 55 years diagnosed with ALL with chromosome Ph 'negative and naïve

Exclusion Criteria:

L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of Burkitt type (t [8, 14], t [2, 8], t [8, 22]).
Biphenotypic acute leukemias and bilinear
Acute undifferentiated leukemia

The criteria for exclusion from treatment (but not patient record) any of the following:

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.

General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), not attributable to the LAL.
LAL chromosome Ph 'positive (must register even if you follow a specific protocol).
Lack of consent by the patient to use their medical records.