Treatment of High Risk Adult Acute Lymphoblastic Leukemia
16 Years
N/A
Both
Acute Lymphoblastic Leukemia
Trial Information
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
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 daunorubicin for 4 weeks. In pts with slow cytologic response to therapy
(≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ARA-C and
mitoxantrone was administered. Early consolidation therapy included 3 cycles with rotating
cytotoxic drugs including high-dose methotrexate, high-dose ARA-C and high-dose
asparaginase. Pts. with slow cytologic response on d14 or MRD level >0.05% after
consolidation were assigned to allogeneic SCT (related or unrelated) and those with standard
cytologic response on d14 and MRD level <0.05% after consolidation received 3 additional
cycles of delayed consolidation (identical to those of early consolidation) followed by
maintenance therapy up to 2yr in CR.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Ribera Josep Mª, Dr
Investigator Role:
Study Chair
Investigator Affiliation:
PETHEMA Foundation
Authority:
Spain: Ministry of Health
Study ID:
LAL-AR/2003
NCT ID:
NCT00853008
Start Date:
January 2003
Completion Date:
January 2014
Related Keywords:
- Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia
- High-Risk (HR)
- Philadelphia Chromosome-Negative
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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