LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

NCT ID: NCT00526305

Last Updated: 2010-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2005-04-30

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

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Vincristine

1,5 mg/m2 i.v., days 1 and 8

Intervention Type: DRUG

Daunorubicin

60 mg/m2, i.v., days 1 and 8

Intervention Type: DRUG

Prednisone

60 mg/m2 day, i.v. or oral, days 1 to 14

Intervention Type: DRUG

L-Asparaginase

10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.

Intervention Type: DRUG

Mitoxantrone

12 mg/m2 i.v days 15, 16 and 17

Intervention Type: DRUG

Cytosine Arabinoside

1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)

Intervention Type: DRUG

Hydrocortisone

10 mg ,15 mg or 20 mg depending of age

Intervention Type: DRUG

Mercaptopurine

50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation

Intervention Type: DRUG

Cyclophosphamide

600 mg/m2 day, i.v., days 1 to 15 in consolidation

Intervention Type: DRUG

Dexamethasone

10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21

Intervention Type: DRUG

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

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PETHEMA Foundation

OTHER

Sponsor Role: lead

Responsible Party

pethema

Principal Investigators

Ribera Josep Mª, Dr

Role: STUDY_CHAIR

Germans Trias i Pujol Hospital

Locations

Hospital General de Alicante

Alicante, Alicante, Spain

Hospital Ntra. Sra. Sonsoles

Ávila, Avila, Spain

Hospital Clínic

Barcelona, Barcelona, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital vall d'Hebrón

Barcelona, Barcelona, Spain

Hospital general de Castellón

Castelló, Castellón, Spain

Hospital Arnau de Vilanova

Lleida, Lleida, Spain

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Marañón, Madrid

Madrid, Madrid, Spain

Hospital Universitario de la Princesa

Madrid, Madrid, Spain

Hospital General Universitario Morales Meseguer.

Murcia, Murcia, Spain

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital de Navarra

Pamplona, Navarre, Spain

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Clínic

Valencia, Valencia, Spain

Hospital dr. Peset

Valencia, Valencia, Spain

Hospital General Universitario

Valencia, Valencia, Spain

Hospital La Fe

Valencia, Valencia, Spain

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Hospital de Badalona Germans Trias i Pujol

Badalona, , Spain

Hospital de Sant Pau

Barcelona, , Spain

Basurtuko Ospitalea

Basurto, , Spain

Hospital de Cruces

Bilbao, , Spain

Hospital de Jerez de la Frontera

Jerez de la Frontera, , Spain

Complejo Hospitalario León

León, , Spain

Complexo Hospitalario Xeral-Calde

Lugo, , Spain

Clínica Puerta de Hierro

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital de la Princesa

Madrid, , Spain

Althaia, Xarxa Asistencial de Manresa

Manresa, , Spain

H. Carlos Haya

Málaga, , Spain

Hospital General Morales Meseguer

Murcia, , Spain

Hospital Santa María del Rosell

Murcia, , Spain

Complejo Asistencial Son Dureta

Palma de Mallorca, , Spain

Hospital Son Llatzer

Palma de Mallorca, , Spain

Clínica Universitaria de Navarra

Pamplona, , Spain

Complejo Hospitalario de Pontevedra_Hospital Montecelo

Pontevedra, , Spain

Corporació Sanitaria Parc Taulí

Sabadell, , Spain

Hospital de Sagunto

Sagunto, , Spain

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, , Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Hospital General de Segovia

Segovia, , Spain

H.U. Virgen del Rocio

Seville, , Spain

Hospital Clínico de Valladolid

Valladolid, , Spain

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Hospital de Galdakao

Vizcaya, , Spain

Countries

Spain

Related Links

http://www.aehh.org

Spanish Association of Haematology

Other Identifiers

LAL-Ph-2000

Identifier Type: -

Identifier Source: org_study_id