PETHEMA LAL-07FRAIL: All Treatment In Fragile Patients Ph' Negative Over 55 Years

January 17, 2022 updated by: PETHEMA Foundation

Treatment Protocol For All Fragile Patients Ph' Negative Over 55 Years

The biological characteristics of the adult LAL, karyotypic and phenotypic particular, are fundamentally different from those of Acute Lymphoblastic Leukemia (ALL) children and, consequently, the results of treatment are substantially lower. Additionally, elderly patients tolerate the drugs considered relatively low-key in the management of the LAL and suffer more toxicity. Although the LAL is much more common in patients over 60 years of age than in younger adults, older adults with ALL are clearly underrepresented in prospective controlled studies. A good portion of elderly patients are not able to tolerate the intensity of the standard treatment applied to children or young adults and a significant portion of them receive only palliative or supportive treatment. The data in the literature relating specifically to the elderly population are scarce and most of them have obtained a stratification by age of study designed for young people (CALGB, GMALL, PETHEMA). To date, the group's recommendation was to treat PETHEMA the LAL-96RI protocol for elderly patients because this protocol less aggressive than those used in high-risk ALL. However, the development of inhibitors of tyrosine kinases LAL effective in Bcr / abl positive, a relatively common type of LAL in the older patient, requires a differentiated treat these patients. Moreover, analysis of data from patients treated so far with the LAL-96RI protocol has shown mediocre results even for LAL Bcr / abl negative. This analysis also showed a significant benefit in survival related to the reduction of treatment (removal of the L-asparaginase during induction and cyclophosphamide at the end of induction) attributed to a reduction in toxicity

Study Overview

Status

Status

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

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

Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml / day. allopurinol 300 mg / day. gastric protection (as center). daily monitoring of blood glucose daily monitoring of renal function.

Intrathecal treatment (diagnosis and prophylactic / therapeutic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge.

Remission induction :

Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction.

Systemic treatment

  • Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22.
  • Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23.

Intrathecal chemotherapy

Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prephase and induction):

MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg

If initial infiltration of the CNS is administered once every 72 hours until the disappearance of blast cell morphology CSF (cytocentrifugation) in at least two consecutive taps. Alternatively be administered liposomal cytarabine (DepoCyt) fortnightly if authorized by the center or in the context of a clinical trial

Maintenance treatment of first year :

Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including myelogram) and will last until one year from the time of documentation of complete remission.

The basic treatment to include mercaptopurine 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly.

Once every 3 months will be added to maintenance treatment a "mini-reinduction" consisting

  • VCR: 1 mg (absolute dose), i.v., day 1.
  • Dexamethasone 40 mg / day, i.v. or p.o., days 1-2.
  • Not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly.

Maintenance of the second year:

After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis.

The initial dose of mercaptopurine and methotrexate will be identical to the first year. Must comply (by increases or decreases of 20% of the dose) to maintain the numbers of neutrophil counts between 1.5 and 3x109/l and platelets above 100x109 / L

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Albacete, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
        • Principal Investigator:
          • Santiago José, Dr
      • Alcorcón, Spain
        • Recruiting
        • Hospital de Alcorcón
      • Alcorcón, Spain
        • Recruiting
        • Fundacion Hospital Alcorcon
        • Principal Investigator:
          • Peñalver Francisco Javier, Dr
      • Alicante, Spain
        • Recruiting
        • Hospital General de Alicante
        • Contact:
          • Fernández Abellán Pascual, Dr
        • Principal Investigator:
          • Fernández Abellán Pascual, Dr
      • Alicante, Spain
        • Recruiting
        • Hoapital General
        • Contact:
          • Fernández Abellán Pascual, Dr
      • Badalona, Spain
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
          • Ribera Josep Mª, Dr
        • Principal Investigator:
          • Ribera Josep Mª, Dr
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain
        • Recruiting
        • Institut Catala d'Oncologia
        • Contact:
          • Boqué Concha, Dr
        • Principal Investigator:
          • Boqué Concha, Dr
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic y Provincial de Barcelona
      • Barcelona, Spain
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau.
      • Barcelona, Spain
        • Recruiting
        • Hospital Valle Hebrón
        • Principal Investigator:
          • Bueno Javier, Dr
      • Basurto, Spain
        • Recruiting
        • Basurtuko Ospitalea
      • Bilbao, Spain
        • Recruiting
        • Hospital de Cruces
        • Principal Investigator:
          • Amutio Díez Elena, Dr
      • Cáceres, Spain
        • Recruiting
        • Complejo Hospitalario de Cáceres
      • Córdoba, Spain
        • Recruiting
        • Complejo Hospitalario Reina Sofía
      • Huelva, Spain
        • Recruiting
        • Area Hospitalaria Juan Ramón Jimenez
      • Jaen, Spain
        • Recruiting
        • Hospital Médico Quirúrgico Ciudad de Jaén
        • Contact:
          • Alcala Antonio, Dr
        • Principal Investigator:
          • Alcalá Antonio, Dr
      • Jerez de la Frontera, Spain
        • Recruiting
        • H. de Jerez
        • Contact:
          • José Luis Guzmán Zamudio, Dr
        • Principal Investigator:
          • Guzmán Zamudio José Luis, Dr
      • La Coruña, Spain
        • Recruiting
        • Hospital Juan Canalejo
        • Contact:
          • Deben Guillermo, Dr
        • Principal Investigator:
          • Deben Guillermo, Dr
      • Leon, Spain
        • Recruiting
        • Complejo Hospitalario León
        • Principal Investigator:
          • Fuertes Nuñez Marta, Dr
      • Lleida, Spain
        • Recruiting
        • Hospital Arnau De Vilanova
      • Lugo, Spain
        • Recruiting
        • Complexo Hospitalario Xeral-Calde
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Recruiting
        • Hospital La Paz
        • Contact:
          • Canales Miguel Ángel, Dr
        • Principal Investigator:
          • Canales Miguel Angel, Dr
      • Madrid, Spain
        • Recruiting
        • Fundacion Jimenez Diaz
        • Principal Investigator:
          • Prieto Elena, Dr
      • Madrid, Spain
        • Recruiting
        • Clínica La Concepción
      • Madrid, Spain
        • Recruiting
        • Clínica Puerta de Hierro
        • Principal Investigator:
          • Krisnk Isabel, Dr
      • Madrid, Spain
        • Recruiting
        • Hospital 12 de Octubre. Madrid
      • Madrid, Spain
        • Recruiting
        • Hospital Clínico San Carlos de Madrid
      • Madrid, Spain
        • Recruiting
        • Hospital De Fuenlabrada
        • Contact:
          • Hernández Rivas José Angel, Dr
        • Principal Investigator:
          • Hernández Rivas José Angel, Dr
      • Madrid, Spain
        • Recruiting
        • Hospital de La Princesa
      • Madrid, Spain
        • Recruiting
        • Hospital de Madrid, S.A.- Norte Hospital General
      • Madrid, Spain
        • Recruiting
        • Clinica Ruber
        • Principal Investigator:
          • Martínez Carmen, Dr
      • Manresa, Spain
        • Recruiting
        • Althaia, Xarxa Asistencial de Manresa
      • Martorell, Spain
        • Recruiting
        • Fundación Hospital Sant Joan de Déu de Martorell
        • Principal Investigator:
          • Las Heras German, Dr
      • Murcia, Spain
        • Recruiting
        • Hospital Sta. Maria del Rosell
      • Murcia, Spain
        • Recruiting
        • Hospital General Morales Meseguer
      • Murcia, Spain
        • Recruiting
        • Hospital Morales Messeguer. Murcia
        • Contact:
          • Amigo Mª Luz, Dr
        • Principal Investigator:
          • Amigo Mª Luz, Dr
      • Málaga, Spain
        • Recruiting
        • Hospital Carlos Haya
      • Málaga, Spain
        • Recruiting
        • . Hospital Clínico Universitario Virgen de la Victoria
      • Málaga, Spain
        • Recruiting
        • Complejo Hospital Costa Del Sol
        • Contact:
          • María Casanova Espinosa, Dr
        • Principal Investigator:
          • Casanova Espinosa María, Dr
      • Málaga, Spain
        • Recruiting
        • H. Carlos Haya
        • Principal Investigator:
          • Negri Silvia, Dr
      • Oviedo, Spain
        • Recruiting
        • Hospital Central de Asturias
        • Contact:
          • Rayón MC, Dr
      • Palencia, Spain
        • Recruiting
        • Hospital del Río Carrión
      • Palma de Mallorca, Spain
        • Recruiting
        • Complejo Asistencial Son Dureta
        • Principal Investigator:
          • Sampol Antonia
      • Pontevedra, Spain
        • Recruiting
        • Complejo Hospitalario de Pontevedra_Hospital Montecelo
      • Pontevedra, Spain
        • Recruiting
        • Complejo Hospitalario de Pontevedra_Hospital Provincial
        • Principal Investigator:
          • Constela Manuel, Dr
      • Sabadell, Spain
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
      • Salamanca, Spain
        • Recruiting
        • Hospital Clínico Universitario de Salamanca
        • Contact:
          • Mateos Mª Victoria, Dr
        • Principal Investigator:
          • Mateos Mª Victoria, Dr
        • Sub-Investigator:
          • Mateo Gema, Dr
        • Sub-Investigator:
          • García Sanz Ramón, Dr
      • Salamanca, Spain
        • Recruiting
        • Hospital Clínico de Salamanca
      • Salamanca, Spain
        • Recruiting
        • Hospital Clínico Universitario
        • Contact:
          • Del Cañizo Consuelo, Dr
      • Sant Pere de Ribes, Spain
        • Recruiting
        • Clínica Sant Camil
        • Principal Investigator:
          • Asensio Antonio, Dr
      • Santander, Spain
        • Recruiting
        • Hoaspital Marqués de Valdecilla
      • Santiago de Compostela, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago
      • Segovia, Spain
        • Recruiting
        • Hospital General de Segovia
        • Principal Investigator:
          • Hernández José Mariano
      • Sevilla, Spain
        • Recruiting
        • Complejo Hospitalario Regional Virgen del Rocío
      • Tarragona, Spain
        • Recruiting
        • Hospital Joan XXIII
      • Valencia, Spain
        • Recruiting
        • Hospital La Fe
      • Valencia, Spain
        • Recruiting
        • Hospital Clínico de Valencia.
      • Valencia, Spain
        • Recruiting
        • Hospital Clinic
      • Valencia, Spain
        • Recruiting
        • Hospital Dr Pesset
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico de Valencia
        • Principal Investigator:
          • Tormo Mar, Dr
      • Valencia, Spain
        • Recruiting
        • Fundación Instituto Valenciano de Oncología
        • Principal Investigator:
          • Llorente Pablo, Dr
      • Valencia, Spain
        • Recruiting
        • Hoapital La Fe
        • Contact:
          • Sanz Miguel Angel, Dr
          • Phone Number: 96 386 27 58
          • Email: msanz@uv.es
      • Valencia, Spain
        • Recruiting
        • Hospital General
        • Contact:
          • Carbonell Félix, Dr
        • Principal Investigator:
          • Carbonell Félix, Dr
      • Valladolid, Spain
        • Recruiting
        • Hospital Clínico de Valladolid
      • Vigo, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Vigo
      • Vinaros, Spain
        • Recruiting
        • Comarcal de Vinaros
        • Principal Investigator:
          • Montagud Mario, Dr
      • Zaragoza, Spain
        • Recruiting
        • Hospital Clinico Lozano Blesa
        • Principal Investigator:
          • Palomera Bernal Luis, Dr
      • Zaragoza, Spain
        • Recruiting
        • Hospital Lozano Blesa. Zaragoza
        • Contact:
          • Olave Mª Teresa, Dr
        • Principal Investigator:
          • Olave Mª Teresa, Dr
    • Baleares
      • Palma de Mallorca, Baleares, Spain
        • Recruiting
        • H. Son Llatzer
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Recruiting
        • Consorci Sanitari de Terrassa
    • Navarra
      • Pamplona, Navarra, Spain
        • Recruiting
        • Clinica Universitaria de Navarra

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

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'negative and not previously treated with frailty (> 3 points in the Charlson comorbidity index)

Exclusion Criteria:

LAL

1. L3 type mature B phenotype (sIg +) or cytogenetic abnormalities characteristic of Burkitt LAL (t [8, 14], t [2, 8], t [8, 22]).

2 . biphenotypic acute leukemias and bilinear 3 . acute undifferentiated leukemia 4 . Patients with a Charlson comorbidity index less than or equal to 3 (and therefore that could potentially benefit from more intensive treatment PETHEMA LAL-07OLD).

5 . General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.

6 . LAL Ph 'positive (though still must register their LAL07OPH specific protocol).

7 . Lack of consent by the patient to use their clinical data

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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
Efficacy in terms of response rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Efficacy in terms disease free survival
Time Frame: 5 years
5 years
Efficacy in terms of global survival
Time Frame: 10 years
10 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

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 (ACTUAL)

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.
May 1, 2010

Primary Completion (ANTICIPATED)

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.
December 1, 2022

Study Completion (ANTICIPATED)

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.
December 1, 2022

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).
May 18, 2011

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.
May 20, 2011

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.
May 23, 2011

Study Record Updates

Last Update Posted (ACTUAL)

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 19, 2022

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 17, 2022

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, 2022

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.
  • PETHEMA LAL-07FRAIL

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.

Clinical Trials on Acute Lymphoblastic Leukemia

Clinical Trials on Methotrexate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings