Clinical trial NCT00526305: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Official title: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Chromosome Philadelphia positive
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 100
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.

Detailed description: Remission Induction:

* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
* Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
* Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13

Results:

1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks

2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C

Intrathecal chemotherapy:

Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT 1

Start in two weeks after last dose of induction chemotherapy:

* Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
* Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
* VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
* ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
* Intrathecal treatment, days 28 and 56.

6.4. CONSOLIDATION TREATMENT 2

Start in a week after last dose of mercaptopurine of previous cycle

* Dexamethasone (DXM):
* 10 mg/m2 day, p.o. or i.v. days 1-14
* 5 mg/m2 day, p.o. or i.v., days 15-21
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
* Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
* CFM 600 mg/m2 day, i.v., days 1 and 15
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
* Intrathecal treatment days 1 and 15.

TRANSPLANTATION

Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.

Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1

Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching

Eligibility criteria: Inclusion Criteria:

ALL BCR/ABL+ patients Age \< 65 years No previous treatment

Exclusion Criteria:

1. Other LLA variability
2. Previous history of coronary valvular, hypertensive cardiopathy illness
3. Chronic hepatic illness
4. Chronic respiratory insufficiency
5. Renal insufficiency not caused by LLA
6. Severe neurological problems not caused by LLA
7. Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA

Primary outcomes:
measure: To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Castello
country: Spain
facility: Hospital general de Castellón
state: Castellón
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Avila
country: Spain
facility: Hospital Ntra. Sra. Sonsoles
city: Badalona
country: Spain
facility: Hospital de Badalona Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital vall d'Hebrón
city: Basurto
country: Spain
facility: Basurtuko Ospitalea
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez de la Frontera
city: Leon
country: Spain
facility: Complejo Hospitalario León
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Lugo
country: Spain
facility: Complexo Hospitalario Xeral-Calde
city: Madrid
country: Spain
facility: Clínica Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón, Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Manresa
country: Spain
facility: Althaia, Xarxa Asistencial de Manresa
city: Murcia
country: Spain
facility: Hospital General Morales Meseguer
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer.
city: Murcia
country: Spain
facility: Hospital Santa María del Rosell
city: Málaga
country: Spain
facility: . Hospital Clínico Universitario Virgen de la Victoria
city: Málaga
country: Spain
facility: H. Carlos Haya
city: Palma de Mallorca
country: Spain
facility: Complejo Asistencial Son Dureta
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra_Hospital Montecelo
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
city: Sagunto
country: Spain
facility: Hospital de Sagunto
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: H.U. Virgen del Rocio
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Clínic
city: Valencia
country: Spain
facility: Hospital dr. Peset
city: Valencia
country: Spain
facility: Hospital General Universitario
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Vizcaya
country: Spain
facility: Hospital de Galdakao
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Ribera Josep Mª, Dr
role: STUDY_CHAIR
References: