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Brief Title: Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Official Title: Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Study ID: NCT00853008
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 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.
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 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.
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital General, Alicante, , Spain
Hospital Germans Trias i Pujol, Badalona, , Spain
Clínica Teknon, Barcelona, , Spain
Hospital Clínic i Provincial, Barcelona, , Spain
Hospital de Sant Pau, Barcelona, , Spain
Hospital Duran y Reynals, Barcelona, , Spain
Hospital Vall d'Hebrón, Barcelona, , Spain
Hospital General, Castellón, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Puerta del Mar, Cádiz, , Spain
Hospital Josep Trueta, Girona, , Spain
Hospital Universitario, Guadalajara, , Spain
Hospital Juan Canalejo, La Coruña, , Spain
Hospital Xeral, Lugo, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Clínico Universitario, Madrid, , Spain
Hospital de Fuenlabrada, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Morales Messeguer, Murcia, , Spain
Hospital Carlos Haya, Málaga, , Spain
Hospital Virgen de la Victoria, Málaga, , Spain
Hospital Central de Asturias, Oviedo, , Spain
Hospital Son Llàtzer, Palma de Mallorca, , Spain
Clínica Universitaria de Navarra, Pamplona, , Spain
Hospital Parc Taulí, Sabadell, , Spain
Hospital Clínico Universitario, Salamanca, , Spain
Hospital Marqués de Valdecilla, Santander, , Spain
Hospital Xeral, Santiago, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Hospital Joan XXIII, Tarragona, , Spain
Hospital Mútua de Terrassa, Terrassa, , Spain
Hospital Clínico Universitario, Valencia, , Spain
Hospital Dr Pesset, Valencia, , Spain
Hospital General, Valencia, , Spain
Hospital La Fe, Valencia, , Spain
Hospital Clínico, Valladolid, , Spain
Hospital Virgen de la Concha, Zamora, , Spain
Hospital Lozano Blesa, Zaragoza, , Spain
Name: Ribera Josep Mª, Dr
Affiliation: PETHEMA Foundation
Role: STUDY_CHAIR