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Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase IV | Treatment | Active | 16 and over | LAL-AR/2003
NCT00853008 |
Trial Description
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. Further Study Information 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 Criteria Inclusion Criteria: - High risk ALL adult patients (age> 15 years)no treated previously
- One or more of the following:
- 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.
- Patients with cardiac pathology
- Patients with chronic liver disease in activity fase
- Renal insufficiency not due to ALL
- Neurological disorders not due to ALL
- PS (grades 3 and 4) not due to ALL.
Trial Contact Information
Trial Lead Organizations/Sponsors Program for the Study and Treatment of Hematological Malignancies | Ribera Josep Mª, Dr | | Study Chair |
Trial Sites
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| Spain |
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Alicante |
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| | | | | | | | Hospital General - Alicante |
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Badalona |
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| | | Hospital Universitari Germans Trias i Pujol |
| | | Ribera Josep Mª, Dr | |
| | | Ribera Josep Mª, Dr | Principal Investigator |
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Barcelona |
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| | | Hospital Clinic de Barcelona |
| | | Esteve Jordi, Dr | |
| | | Esteve Jordi, Dr | Principal Investigator |
| | | Hospital de la Santa Cruz i Sant Pau |
| | | Brunet Salut, Dr | |
| | | Salut Brunet, Dr | Principal Investigator |
| | | Institut Catala d'Oncologia - Hospital Duran i Reynals |
| | | Instituto Oncologico Teknon at Centro Medico Teknon |
| | | Vall d'Hebron University Hospital |
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Cáceres |
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| | | Hospital San Pedro de Alcantara |
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Cádiz |
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| | | Hospital Universitario Puerta Del Mar |
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Castellón |
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| | | Hospital General de Castellon |
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Girona |
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| | | Hospital Universitari Josep Trueta de Girona |
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Guadalajara |
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| | | Hospital General Universitario De Guadalajara |
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La Coruña |
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| | | Hospital Universitario Juan Canalejo |
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Lugo |
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| | | Hospital Xeral de Lugo |
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Madrid |
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| | | Hospital Ramon y Cajal |
| | | Hospital Universitario 12 de Octubre |
| | | Hospital Universitario de Fuenlabrada |
| | | Hospital Universitario San Carlos |
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Málaga |
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| | | Hospital Regional Carlos Haya De Malaga |
| | | Bethancourt Concepción, Dr | |
| | | Bethancourt Concepción, Dr | Principal Investigator |
| | | Hospital Universitario Virgen de la Victoria |
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Murcia |
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| | | Hospital General Universitario Morales Meseguer |
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Oviedo |
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| | | Hospital Universitario Central de Asturias |
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Palma de Mallorca |
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| | | Hospital Son Llatzer |
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Pamplona |
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| | | Clinica Universitaria |
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Sabadell |
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| | | Hospital Parc Taulí |
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Salamanca |
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| | | University Hospital - Salamanca |
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Santander |
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| | | Hospital Universitario Marques de Valdecilla |
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Santiago |
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| | | Hospital Xeral |
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Sevilla |
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| | | Hospital Universidad Virgen Del Rocio |
| | | Parody Ricardo, Dr | |
| | | Parody Ricardo, Dr | Principal Investigator |
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Tarragona |
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| | | Hospital Universitari de Tarragona Joan XXIII |
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Terrassa |
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| | | Hospital Mutua de Terrassa |
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Valencia |
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| | | Hospital Clinico Universitario de Valencia |
| | | Hospital General Universitario Valencia |
| | | Hospital Universitario Dr. Peset |
| | | Hospital Universitario La Fe |
| | | Sanz Miguel Angel | Principal Investigator |
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Valladolid |
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| | | Universidad de Valladolid |
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Zamora |
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| | | Hospital Virgen de la Concha |
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Zaragoza |
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| | | Hospital Clinico Universitario Lozano Blesa |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00853008
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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