Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL treated with a pediatric protocol.

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

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: 6-Mercaptopurine; Asparaginase; Daunorubicin; Mercaptopurine; Prednisone; Vincristine

Criteria

Inclusion Criteria:

Adults (age> 15 years) with ALL standard risk previously untreated. The LAL standard risk is defined by all of the following criteria:

• Age less than 30 years

• WBC <25x109 / L

• Absence of cytogenetic alterations that misbehave forecast or t (9, 22) or demonstration of BCR-ABL rearrangement or alterations in 11q23, or demonstration ALL1-AF4 rearrangement (MLL)

Exclusion Criteria:

LAL L3 type mature phenotype B (sIg +) or with cytogenetic abnormalities characteristic of Burkitt LAL (t [8, 14], t [2, 8], t [8, 22]). For these patients have the BURKIMAB study.

• LAL Ph (BCR-ABL) positive. These patients should be treated with imatinib associated with chemotherapy.

• Biphenotypic acute leukemias and bilinear. For these patients treatment is recommended LAM own guidelines.

• Acute undifferentiated leukemias. For these patients treatment is recommended LAM own guidelines.

• Patients with a history of coronary artery disease, valvular or hypertensive heart disease.

• Patients with chronic liver disease.

• Patients with chronic respiratory failure.

• Renal failure not due to the LAL.

• Severe neurological disorders, not due to the LAL.

• General State concerned (grades 3 and 4 WHO scale), not attributable to the LAL.