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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PETHEMA Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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