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

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Brief Title

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

Official Title

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

Brief 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
    

Detailed 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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time


Condition

Acute Lymphoblastic Leukemia

Intervention

Prednisolone


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

June 2005

Completion Date

October 2014

Primary Completion Date

October 2014

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 16 Years

Accepts Healthy Volunteers

No

Contacts

Bastida Pilar, Dr, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00526409

Organization ID

LAL-AR-N-2005


Responsible Party

Sponsor

Study Sponsor

PETHEMA Foundation


Study Sponsor

Bastida Pilar, Dr, Study Chair, Hospital Universitari Materno-Infantil Vall d'Hebron


Verification Date

October 2014