Overview

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PETHEMA Foundation
Treatments:
6-Mercaptopurine
BB 1101
Cortisol succinate
Cytarabine
Daunorubicin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Mercaptopurine
Methotrexate
Mitoxantrone
Prednisone
Teniposide
Vincristine
Criteria
Inclusion Criteria:

- High risk ALL adult patients (age> 15 years)no treated previously

- High-risk ALL:

- One or more of the following:

- Age 30-60 yr.

- WBC count >25x109/L

- 11q23 or ALL1/AF4

- Very high-risk ALL:

- HR ALL and one or the following:

- Slow cytologic response (>10% blasts in BM on d14 of induction therapy).

- MRD>0.05% (by flow cytometry) at the end of consolidation

Exclusion Criteria:

- L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).

- ALL Ph (BCR/ABL) positive.

- Bifenotipics ALL as EGIL criteria.

- Indifferentiated ALL.

- Patients with cardiac pathology

- Patients with chronic liver disease in activity fase

- Pulmonary disease

- Renal insufficiency not due to ALL

- Neurological disorders not due to ALL

- PS (grades 3 and 4) not due to ALL.