LAL-AR-N-2005:Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

— LAL-AR-N-2005  

Official title:

LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526409
• Other study ID #: LAL-AR-N-2005
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2007
• Last updated: October 27, 2014
• Start date: June 2005
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%.

Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation

Description:

INDUCTION TREATMENT

Systemic chemotherapy:

PREDNISOLONE 60 mg/m2 /day, oral or i.v. x 21 days (1 to 22) 30 mg/m2 /day, oral or i.v. x 7 days (23 to 29)

DAUNORUBICIN 30 mg/m2 , i.v. days 1,8,15 and 22

VINCRISTINE 1,5 mg/m2, i.v. days 1,8,15 and 22

L-ASPARAGINASE 10.000U/m2 i.m or i.v day 9,11,13,16,18,20,23,25 and 27

CYCLOPHOSPHAMIDE 500 mg/m2 i.v. days 1,2 and 29

Intrathecal chemotherapy:

Days 1 and 22 according age:

Age <1 years 1-3 years >3 years

Methotrexate (MTX), mg 5 8 12 Ara-C, mg 16 20 30 Hydrocortisone,mg 10 10 20

Patients with <10% blasts in M.O (day 14), and in complete response on week 5 or 6, and without MDR, start consolidation-intensification phase.

Patients with >10% blasts in MO day +14 or without CR after induction treatment, start consolidation-intensification phase and identifier a donor for a transplantation.

CONSOLIDATION/INTENSIFICATION (C.I.)

Two sequential cycles, alternating bloc I and bloc II

BLOC I

DEXAMETHASONE 10 mg/m2/d vo. days 1 to 5 and 5 mg/m2/d vo. days 6 and 7

VINCRISTINE 1.5 mg/m2/d, i.v. days 1 and 8

METHOTREXATE 5 g/m2 24 hours infusion + AF, day 1

ARA-C 1 g/m2/12 h, i.v., days 5 and 6

MERCAPTOPURINE 100 mg/m2/d, oral, days 1 to 5

CYCLOPHOSPHAMIDE 500 mg/m2 i.v. el day +8

INTRATHECAL CHEMOTHERAPY day 1.

BLOC II

DEXAMETHASONE 10 mg/m2/d, v o. days 1-5 and 5 mg/m2/d, v o. days 6 and 7

VINCRISTINE 1.5 mg/m2/d, days 1 and 8

METHOTREXATE 5 g/m2 24 h infusion + AF, day 1

ARA-C 1 g/m2 i.v/12 h, days 5 and 6

DAUNORUBICINE 30 mg/m2 i.v.day 1

L-ASPARAGINASE 20.000 u/m2/d, i.m. or i.v. day 7

INTRATHECAL CHEMOTHERAPY day 1

Patients with CR and MRD negative, follow chemotherapy. Patients with MDR >0.01% after second cycle or considered previously MRD are candidates to allogenic transplantation after second cycle.

REINDUCTION/INTENSIFICATION TREATMENT (R.I.)

PREDNISOLONE 60 mg/m2/d, oral x 14 days (1-14) 30 mg/m2/d, oral x 7 days (15-22)

VINCRISTINE 1.5 mg/m2, i.v. x 2 days 1 and 8

DAUNORUBICINE 30 mg/m2 i.v x 2 , days 1 and 8

CYCLOPHOSPHAMIDE 500 mg/m2 I.V. day 15

METHOTREXATE 3 g/m2 /24 h infusion + AF day 29

MERCAPTOPURINE 50 mg/m2/d, oral, days 29-35 and 43-50

ARA-C 1 g/m2/12 h., i.v., days 43 and 44

INTRATHECAL CHEMOTHERAPY , days 1, 15, 29 and 43

MAINTENANACE TREATMENT (M1)

Six cycles of:

MERCAPTOPURINE 50 mg/m2/d, oral x 21 days (1-21)

METHOTREXATE 20 mg/m2/d, i.m. /week x 3 (1,7,14)

PREDNISOLONE 60 mg/m2/d, oral x 7 days (22-28)

VINCRISTINE 1.5 mg/m2 i.v.day 22

ASPARAGINASE 20.000 u/m2 i.m. day 22

INTRATHECAL CHEMOTHERAPY day 22

MAINTENANCE TREATMENT (M2)

Diary mercaptopurine and weekly methotrexate at previous doses, until complete 24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• High risk children with acute lymphoblastic leukemia

Exclusion Criteria:

• Mature B-ALL (FABL3)

• Mixed forms of ALL

• Patients with coronary disorders, valvular or hypertensive cardiopathy

• Patients with chronic liver disorders

• Chronic pulmonary disorders

• Renal insufficiency

• Neurologic disfunctions

• ECOG 3 and 4

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:
• Prednisolone
Induction: 60 mg/m2/day, oral or i.v x 21 days and 30 mg/m2/day oral or iv x 7 days Reinduction-Intensification Treatment: 60 mg/m2/d x 14 days and 30 mg/m2/day oral x 7 days
• Daunorubicin
Induction: 30 mg/m2, i.v, days 1, 8, 15, 22 Consolidation (Bloc II)30 mg/m2, i.v, day 1
• Vincristine
Induction: 1,5 mg/m2 iv, days 1, 8, 15, 22 Consolidation (Bloc I):1,5 mg/m2 iv, days 1, 8 Consolidation (Bloc II):1,5 mg/m2 iv, days 1, 8 Reinduction: 1,5 mg/m2 iv, days 1, 8 Maintenance:1,5 mg/m2 iv, day 22
• L-Asparaginase
Induction: 10.000 U/m2 im or iv, days 9,11,13,16,18,20,23,25,27 Consolidation (Bloc II): 20.000 U/m2 im or iv, day 7 Maintenance: 20.000 U/m2 im or iv, day 22
• Cyclophosphamide
Induction: 500 mg/m2 iv, days 1, 2, 29 Consolidation (Bloc I): 500 mg/m2 iv, day 8 Reinduction:500 mg/m2 iv, day 15
• Methotrexate
Consolidation (Bloc I): 5 g/m2 24 hours infusion Consolidation (Bloc II): 5 g/m2 24 hours infusion Reinduction: 3 g/m2 24 hours infusion Maintenance: 20 mg/m2/d, IM/week x 3 (1, 7, 14)
• Cytosine Arabinoside
Consolidation (Bloc I): 1 g/m2/12 h iv, days 5, 6 Consolidation (Bloc II): 1 g/m2/12 h iv, days 5, 6 Reinduction: 1 g/m2/12 h iv, days 43, 44

Locations

Country	Name	City	State
Spain	Hospital materno Infantil vall d'Hebrón	Barcelona
Spain	Hospital Niño Jesús	Madrid
Spain	Hospital Infantil Carlos Haya	Málaga
Spain	Hospital Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time		2 years	No

External Links

•   Pethema Foundation web
•   Spanish association of Haematology