Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Sponsors

Lead Sponsor: PETHEMA Foundation

Source 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.

Overall Status Completed
Start Date 2003-01-01
Completion Date 2012-12-01
Primary Completion Date 2012-11-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Vincristine

Description: Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)

Intervention Type: Drug

Intervention Name: Daunorubicin

Description: Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22

Intervention Type: Drug

Intervention Name: Prednisone

Description: Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28

Intervention Type: Drug

Intervention Name: Mitoxantrone

Description: Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation

Intervention Type: Drug

Intervention Name: Cytosine Arabinoside

Description: ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)

Intervention Type: Drug

Intervention Name: Methotrexate (MTX)

Description: Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT

Intervention Type: Drug

Intervention Name: Cytarabine

Description: Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal

Intervention Type: Drug

Intervention Name: ASP

Description: ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)

Intervention Type: Drug

Intervention Name: Mercaptopurine

Description: Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation

Intervention Type: Drug

Intervention Name: Teniposide

Description: Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3

Intervention Type: Drug

Intervention Name: Hydrocortisone

Description: Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ribera Josep Mª, Dr Study Chair PETHEMA Foundation
Location
Facility:
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
Location Countries

Spain

Verification Date

2020-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym LAL-AR/2003
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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