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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526305
• Other study ID #: LAL-Ph-2000
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2007
• Last updated: January 3, 2010
• Start date: January 2000
• Est. completion date: April 2005

Study information

• Verified date: January 2010
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Abnormal Karyotype
• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Vincristine
1,5 mg/m2 i.v., days 1 and 8
• Daunorubicin
60 mg/m2, i.v., days 1 and 8
• Prednisone
60 mg/m2 day, i.v. or oral, days 1 to 14
• L-Asparaginase
10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
• Mitoxantrone
12 mg/m2 i.v days 15, 16 and 17
• 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)
• Hydrocortisone
10 mg ,15 mg or 20 mg depending of age
• Mercaptopurine
50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
• Cyclophosphamide
600 mg/m2 day, i.v., days 1 to 15 in consolidation
• Dexamethasone
10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21

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 de Badalona Germans Trias i Pujol	Badalona
Spain	Hospital Clínic	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital vall d'Hebrón	Barcelona
Spain	Basurtuko Ospitalea	Basurto
Spain	Hospital de Cruces	Bilbao
Spain	Hospital general de Castellón	Castello	Castellón
Spain	Hospital de Jerez de la Frontera	Jerez de La Frontera
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 la Princesa	Madrid
Spain	Hospital General Universitario Gregorio Marañón, Madrid	Madrid
Spain	Hospital Universitario de la Princesa	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 General Universitario Morales Meseguer.	Murcia
Spain	Hospital Santa María del Rosell	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Complejo Asistencial Son Dureta	Palma de Mallorca
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Clínica Universitaria de Navarra	Pamplona
Spain	Hospital de Navarra	Pamplona	Navarra
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	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela
Spain	Hospital General de Segovia	Segovia
Spain	H.U. Virgen del Rocio	Sevilla
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Verge de la Cinta	Tortosa	Tarragona
Spain	Hospital Clínic	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital dr. Peset	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 de Galdakao	Vizcaya
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival		5 years	No

External Links

•   Pethema Foundation
•   Spanish Association of Haematology