Status:
COMPLETED
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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 decision...
Detailed Description
HR ALL included one or more of the following baseline parameters: age 30-60 yr, WBC count \>25x109/L and 11q23 or MLL rearrangements. Induction therapy included vincristine, prednisone and daunorubici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00853008
Start Date
January 1 2003
End Date
December 1 2012
Last Update
April 7 2020
Active Locations (38)
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1
Hospital Juan Canalejo
A Coruña, Spain
2
Hospital General
Alicante, Spain
3
Hospital Germans Trias i Pujol
Badalona, Spain
4
Clínica Teknon
Barcelona, Spain