Clinical trial · Interventional
Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasona, Idarubicine, ARA-C, Methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- interventionNames
- Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate
Primary outcomes (1)
- measure
- Efficacy in terms of response rate
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
- Efficacy in terms disease free survival
- timeFrame
- 5 years
- measure
- Efficacy in terms of global survival
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRibera JM, Garcia O, Fernandez-Abellan P, Lavilla E, Bernal MT, Gonzalez-Campos J, Brunet S, Monteserin MC, Montesinos P, Sarra J, Calbacho M, Alvarez-Larran A, Tormo M, Oriol A; PETHEMA Group. Lack of negative impact of Philadelphia chromosome in older patients with acute lymphoblastic leukaemia in the thyrosine kinase inhibitor era: comparison of two prospective parallel protocols. Br J Haematol. 2012 Nov;159(4):485-8. doi: 10.1111/bjh.12043. Epub 2012 Sep 12. No abstract available. PMID 22966847