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Spots Global Cancer Trial Database for Treatment of High Risk Adult Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Official Title: Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Study ID: NCT00853008

Study Description

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.

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Ribera Josep Mª, Dr

Affiliation: PETHEMA Foundation

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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