Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Phase 4

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT00853008
• Lead Sponsor: PETHEMA Foundation

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2009-02-25
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (33)

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Clínica Teknon; 🇪🇸 Barcelona, Spain

Hospital de Fuenlabrada; 🇪🇸 Madrid, Spain

Hospital General; 🇪🇸 Valencia, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital Universitario; 🇪🇸 Guadalajara, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Hospital Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Juan Canalejo; 🇪🇸 La Coruña, Spain

Hospital Josep Trueta; 🇪🇸 Girona, Spain

Hospital Clínico Universitario; 🇪🇸 Valencia, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Son Llàtzer; 🇪🇸 Palma de Mallorca, Spain

Hospital Morales Messeguer; 🇪🇸 Murcia, Spain

Hospital Parc Taulí; 🇪🇸 Sabadell, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Dr Pesset; 🇪🇸 Valencia, Spain

Hospital Clínico; 🇪🇸 Valladolid, Spain

Hospital Virgen de la Concha; 🇪🇸 Zamora, Spain

Hospital Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital Clínic i Provincial; 🇪🇸 Barcelona, Spain

Hospital Xeral; 🇪🇸 Santiago, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Hospital Mútua de Terrassa; 🇪🇸 Terrassa, Spain

Hospital Duran y Reynals; 🇪🇸 Barcelona, Spain