PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494897
• Other study ID #: LAL-RI/96
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2007
• Last updated: May 15, 2009
• Start date: June 1996
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.

Description:

Induction therapy:

Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.

Patients older than 55 years are not treated with asparaginase and cyclophosphamide.

Consolidation therapy (1):

Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2 IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase: 10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15

Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis.

• Continuous chemotherapy:

• MP 50 mg/m2/day PO

• MTX 20 mg/m2/week IM

• Reinductions

• VCR: 1,5 mg/m2 IV, day 1.

• PDN: 60 mg/m2/day, IV or PO days 1 to 7

• L-ASA: 20.000 UI/m2, IM or IV day 1.

• Intrathecally day 1

Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.

Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104).

• MP 50 mg/m2/day, PO

• MTX 20 mg/m2/week, IM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: December 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy

Exclusion Criteria:

• Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])

• Mixed forms of ALL

• Acute Leukemia no differentiate

• Patients with coronary disorders, valvular or hypertensive cardiopathy

• Patients with chronic liver disorders

• Chronic pulmonary disorders

• Renal insufficiency

• Neurologic disfunctions

• ECOG 3 and 4

• No signed consent form

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Asparaginase

• Cyclophosphamide

• Cytarabine

• Daunorubicin

• Mercaptopurine

• Prednisone

• Vincristine

• Methotrexate

Procedure:
• Intrathecally treatment

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Ntra. Sra. Sonsoles	Avila
Spain	Hospital Regional Universitario Infanta Cristina	Badajoz
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital vall d'Hebrón	Barcelona
Spain	Hospital Valle Hebrón-Materno Infantil	Barcelona
Spain	Basurtuko Ospitalea	Basurto
Spain	Complejo Hospitalario de Cáceres	Cáceres
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital general de Castellón	Castello	Castellón
Spain	Hospital Nuestra Señora de Alarcos	Ciudad Real
Spain	Complejo Hospitalario Reina Sofía	Córdoba
Spain	Hospital Virgen de la Luz	Cuenca
Spain	Hospital General de Elda	Elda
Spain	Institut Català d'Oncologia,	Gerona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital de San Jorge	Huesca
Spain	Hospital Médico Quirúrgico Ciudad de Jaén	Jaen
Spain	Hospital de Jerez de la Frontera	Jerez de la Frontera
Spain	Hospital Juan Canalejo	La Coruña
Spain	Hospital General de Lanzarote	Lanzarote
Spain	Complejo Hospitalario León	Leon
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Complexo Hospitalario Xeral-Calde	Lugo
Spain	Clínica Puerta de Hierro	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos de Madrid	Madrid
Spain	Hospital de Fuenlabrada	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital General Universitario Gregorio Marañón, Madrid	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Princcipe de Asturias	Madrid
Spain	. Hospital Clínico Universitario Virgen de la Victoria	Málaga
Spain	H. Carlos Haya	Málaga
Spain	Althaia, Xarxa Asistencial de Manresa	Manresa
Spain	Hospital General Morales Meseguer	Murcia
Spain	Hospital Santa María del Rosell	Murcia
Spain	Hospital Virgen del Castillo de Yecla	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital del Río Carrión	Palencia
Spain	Complejo Asistencial Son Dureta	Palma de Mallorca
Spain	Hospital Son Dureta	Palma de Mallorca
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Hospital Verge del Toro	Palma de Mallorca
Spain	Clínica Universitaria de Navarra	Pamplona
Spain	Hospital Virgen del Camino	Pamplona
Spain	Complejo Hospitalario de Pontevedra_Hospital Montecelo	Pontevedra
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital de Sagunto	Sagunto
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital San Pedro de Alcántara	San Pedro de Alcántara
Spain	Clínica Sant Camil	Sant Pere de Ribes
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela
Spain	Hospital de Santiago de Compostela	Santiago de Compostela
Spain	Hospital General de Segovia	Segovia
Spain	H.U. Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Joan XXIII	Tarragona
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Mútua de Terrassa	Terrassa	Barcelona
Spain	Hospital Nuestra Señora del Prado	Toledo
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Verge de la Cinta	Tortosa	Tarragona
Spain	Fundación Instituto Valenciano de Oncología	Valencia
Spain	Hospital Clínic	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Dr. Peset	Valencia
Spain	Hospital Francesc de Borja	Valencia
Spain	Hospital General Básico de la Defensa	Valencia
Spain	Hospital General Universitario	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Complejo Hospitalario Universitario de Vigo	Vigo
Spain	Hospital Meixoeiro	Vigo
Spain	Hospital Txagorritxu	Vitoria
Spain	Hospital de Galdakao	Vizcaya
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia		2 years
Secondary	Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy		2 years
Secondary	To evaluate the treatment tolerance		1 year

External Links

•   Pethema Foundation web
•   Spanish association of Haematology