This trial is active, not recruiting.

Condition acute lymphoblastic leukemia
Treatments vincristine, daunorubicin, prednisone, mitoxantrone, cytosine arabinoside, dexamethasone, methotrexate (mtx), cytarabine, asp, mercaptopurine, teniposide, hydrocortisone
Phase phase 4
Sponsor PETHEMA Foundation
Start date January 2003
End date December 2017
Trial size 100 participants
Trial identifier NCT00853008, LAL-AR/2003


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 16 years old.

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.

Additional Information

Official title Treatment of High Risk Adult Acute Lymphoblastic Leukemia
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by PETHEMA Foundation.