Treatment of High Risk Adult Acute Lymphoblastic Leukemia
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|
|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|
|Alicante, Spain||Hospital General||no longer recruiting|
|Badalona, Spain||Hospital Germans Trias i Pujol||no longer recruiting|
|Barcelona, Spain||Clínica Teknon||no longer recruiting|
|Barcelona, Spain||Hospital Clínic i Provincial||no longer recruiting|
|Barcelona, Spain||Hospital de Sant Pau||no longer recruiting|
|Barcelona, Spain||Hospital Duran y Reynals||no longer recruiting|
|Barcelona, Spain||Hospital Vall d'Hebrón||no longer recruiting|
|Castellón, Spain||Hospital General||no longer recruiting|
|Cáceres, Spain||Hospital San Pedro de Alcántara||no longer recruiting|
|Cádiz, Spain||Hospital Puerta del Mar||no longer recruiting|
|Girona, Spain||Hospital Josep Trueta||no longer recruiting|
|Guadalajara, Spain||Hospital Universitario||no longer recruiting|
|La Coruña, Spain||Hospital Juan Canalejo||no longer recruiting|
|Lugo, Spain||Hospital Xeral||no longer recruiting|
|Madrid, Spain||Hospital 12 de Octubre||no longer recruiting|
|Madrid, Spain||Hospital Clínico Universitario||no longer recruiting|
|Madrid, Spain||Hospital de Fuenlabrada||no longer recruiting|
|Madrid, Spain||Hospital Ramón y Cajal||no longer recruiting|
|Murcia, Spain||Hospital Morales Messeguer||no longer recruiting|
|Málaga, Spain||Hospital Carlos Haya||no longer recruiting|
|Málaga, Spain||Hospital Virgen de la Victoria||no longer recruiting|
|Oviedo, Spain||Hospital Central de Asturias||no longer recruiting|
|Palma de Mallorca, Spain||Hospital Son Llàtzer||no longer recruiting|
|Pamplona, Spain||Clínica Universitaria de Navarra||no longer recruiting|
|Sabadell, Spain||Hospital Parc Taulí||no longer recruiting|
|Salamanca, Spain||Hospital Clínico Universitario||no longer recruiting|
|Santander, Spain||Hospital Marqués de Valdecilla||no longer recruiting|
|Santiago, Spain||Hospital Xeral||no longer recruiting|
|Sevilla, Spain||Hospital Virgen del Rocio||no longer recruiting|
|Tarragona, Spain||Hospital Joan XXIII||no longer recruiting|
|Terrassa, Spain||Hospital Mútua de Terrassa||no longer recruiting|
|Valencia, Spain||Hospital Clínico Universitario||no longer recruiting|
|Valencia, Spain||Hospital Dr Pesset||no longer recruiting|
|Valencia, Spain||Hospital General||no longer recruiting|
|Valencia, Spain||Hospital La Fe||no longer recruiting|
|Valladolid, Spain||Hospital Clínico||no longer recruiting|
|Zamora, Spain||Hospital Virgen de la Concha||no longer recruiting|
|Zaragoza, Spain||Hospital Lozano Blesa||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
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
Male or female participants at least 16 years old.
- 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
- 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.
|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.|
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