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

October 27, 2014 updated by: PETHEMA Foundation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Materno Infantil Vall d'Hebron
      • Madrid, Spain
        • Hospital Niño Jesús
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Málaga, Spain
        • Hospital Infantil Carlos Haya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To improve the global results obtained in PETHEMA LAL-AR-93 study in terms of events free time
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Study Chair: Bastida Pilar, Dr, Hospital Universitari Materno-Infantil Vall d'Hebron
  • Study Chair: Ribera Josep Mª, Dr, Germans Trias i Pujol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAL-AR-N-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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