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

January 3, 2010 updated by: PETHEMA Foundation
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.

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

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:

1. 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 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.
100

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
      • Albacete, Spain
        • Complejo Hospitalario Universitario de Albacete
      • Alicante, Spain
        • Hospital General de Alicante
      • Avila, Spain
        • Hospital Ntra. Sra. Sonsoles
      • Badalona, Spain
        • Hospital de Badalona Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clinic
      • Basurto, Spain
        • Basurtuko Ospitalea
      • Bilbao, Spain
        • Hospital de Cruces
      • Jerez de La Frontera, Spain
        • Hospital De Jerez De La Frontera
      • Leon, Spain
        • Complejo Hospitalario León
      • Lleida, Spain
        • Hospital Arnau De Vilanova
      • Lugo, Spain
        • Complexo Hospitalario Xeral-Calde
      • Madrid, Spain
        • Hospital Clínico San Carlos de Madrid
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario de La Princesa
      • Madrid, Spain
        • Hospital de La Princesa
      • Madrid, Spain
        • Clínica Puerta de Hierro
      • Madrid, Spain
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON, MADRID
      • Manresa, Spain
        • Althaia, Xarxa Asistencial de Manresa
      • Murcia, Spain
        • Hospital General Morales Meseguer
      • Murcia, Spain
        • Hospital General Universitario Morales Meseguer.
      • Murcia, Spain
        • Hospital Santa Maria del Rosell
      • Málaga, Spain
        • . Hospital Clínico Universitario Virgen de la Victoria
      • Málaga, Spain
        • H. Carlos Haya
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Palma de Mallorca, Spain
        • Complejo Asistencial Son Dureta
      • Pamplona, Spain
        • Clinica Universitaria de Navarra
      • Pontevedra, Spain
        • Complejo Hospitalario de Pontevedra_Hospital Montecelo
      • Sabadell, Spain
        • Corporacio Sanitaria Parc Tauli
      • Sagunto, Spain
        • Hospital de Sagunto
      • Salamanca, Spain
        • Hospital Clinico Universitario de Salamanca
      • Santiago de Compostela, Spain
        • Complejo Hospitalario Universitario de Santiago
      • Segovia, Spain
        • Hospital General de Segovia
      • Sevilla, Spain
        • H.U. Virgen del Rocío
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Valencia, Spain
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain
        • Hospital General Universitario
      • Valencia, Spain
        • Hospital Clinic
      • Valencia, Spain
        • Hospital Dr. Peset
      • Valladolid, Spain
        • Hospital Clínico de Valladolid
      • Vigo, Spain
        • Complejo Hospitalario Universitario de Vigo
      • Vizcaya, Spain
        • Hospital de Galdakao
      • Zaragoza, Spain
        • Hospital Clinico Lozano Blesa
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Central de Asturias
    • Castellón
      • Castello, Castellón, Spain
        • Hospital General de Castellon
    • Navarra
      • Pamplona, Navarra, Spain
        • Hospital De Navarra
    • Tarragona
      • Tortosa, Tarragona, Spain
        • Hospital Verge de la Cinta

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 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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 evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival
Time Frame: 5 years
5 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: 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.
January 1, 2000

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.
April 1, 2005

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.
April 1, 2005

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 5, 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.
January 5, 2010

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.
January 3, 2010

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.
January 1, 2010

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-Ph-2000

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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