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

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00526305

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Vincristine Drug: Daunorubicin Drug: Prednisone Drug: L-Asparaginase Drug: Mitoxantrone Drug: Cytosine Arabinoside Drug: Hydrocortisone Drug: Mercaptopurine Drug: Cyclophosphamide Drug: Dexamethasone	Phase 4

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Central de Asturias	Oviedo	Asturias	Spain
2	Hospital general de Castellón	Castello	Castellón	Spain
3	Hospital de Navarra	Pamplona	Navarra	Spain
4	Hospital Verge de la Cinta	Tortosa	Tarragona	Spain
5	Complejo Hospitalario Universitario de Albacete	Albacete		Spain
6	Hospital General de Alicante	Alicante		Spain
7	Hospital Ntra. Sra. Sonsoles	Avila		Spain
8	Hospital de Badalona Germans Trias i Pujol	Badalona		Spain
9	Hospital Clínic	Barcelona		Spain
10	Hospital de Sant Pau	Barcelona		Spain
11	Hospital del Mar	Barcelona		Spain
12	Hospital vall d'Hebrón	Barcelona		Spain
13	Basurtuko Ospitalea	Basurto		Spain
14	Hospital de Cruces	Bilbao		Spain
15	Hospital de Jerez de la Frontera	Jerez de La Frontera		Spain
16	Complejo Hospitalario León	Leon		Spain
17	Hospital Arnau de Vilanova	Lleida		Spain
18	Complexo Hospitalario Xeral-Calde	Lugo		Spain
19	Clínica Puerta de Hierro	Madrid		Spain
20	Hospital 12 de Octubre	Madrid		Spain
21	Hospital Clínico San Carlos de Madrid	Madrid		Spain
22	Hospital de la Princesa	Madrid		Spain
23	Hospital General Universitario Gregorio Marañón, Madrid	Madrid		Spain
24	Hospital Universitario de la Princesa	Madrid		Spain
25	Althaia, Xarxa Asistencial de Manresa	Manresa		Spain
26	Hospital General Morales Meseguer	Murcia		Spain
27	Hospital General Universitario Morales Meseguer.	Murcia		Spain
28	Hospital Santa María del Rosell	Murcia		Spain
29	. Hospital Clínico Universitario Virgen de la Victoria	Málaga		Spain
30	H. Carlos Haya	Málaga		Spain
31	Complejo Asistencial Son Dureta	Palma de Mallorca		Spain
32	Hospital Son Llatzer	Palma de Mallorca		Spain
33	Clínica Universitaria de Navarra	Pamplona		Spain
34	Complejo Hospitalario de Pontevedra_Hospital Montecelo	Pontevedra		Spain
35	Corporació Sanitaria Parc Taulí	Sabadell		Spain
36	Hospital de Sagunto	Sagunto		Spain
37	Hospital Clínico Universitario de Salamanca	Salamanca		Spain
38	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela		Spain
39	Hospital General de Segovia	Segovia		Spain
40	H.U. Virgen del Rocio	Sevilla		Spain
41	Hospital Universitario de Canarias	Tenerife		Spain
42	Hospital Clínico Universitario de Valencia	Valencia		Spain
43	Hospital Clínic	Valencia		Spain
44	Hospital dr. Peset	Valencia		Spain
45	Hospital General Universitario	Valencia		Spain
46	Hospital La Fe	Valencia		Spain
47	Hospital Clínico de Valladolid	Valladolid		Spain
48	Complejo Hospitalario Universitario de Vigo	Vigo		Spain
49	Hospital de Galdakao	Vizcaya		Spain
50	Hospital Clínico Lozano Blesa	Zaragoza		Spain