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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Idarubicin; Methotrexate

Criteria

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.