Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)

January 17, 2022 updated by: PETHEMA Foundation

PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)

The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day IV 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) 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. The total duration of the induction is 30 days, consists of two phases (Phase I, days +1 to +14 and phase II, days +15 to +30). Mandatory testing is considered counting the percentage of blasts in peripheral blood +8 day of induction, a myelogram to day +14 to assess early response and a day +35 to assess the complete remission

(days +1 to +14)

  • Vincristine (VCR) 1 mg (absolute dose) IV 1 and 8.
  • Idarubicin (IDA): 10 mg (absolute dose) IV 1, 2, 8 and 9.
  • Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 IV, 8 to 11

days +15 to +30)

  • cyclophosphamide (CFM): 300 mg / m 2 iV in 1 hour 15 to 17. (3 total doses).
  • Cytarabine (ARAC): 60 mg / m 2 iV in 1 hour 16 to 19, 23 to 26. (8 total doses).
  • Vincristine (VCR) 1 mg (absolute dose) iV 1 and 8.
  • Idarubicin (IDA): 10 mg (absolute dose) iV 1, 2, 8 and 9.
  • Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 iV, 8 to 11

Consolidation:

Cycles 1, 3, 5 MTX: 1,000 mg/m2, IV infusion of 24 hours day 1 L-ASA. 10,000 IU / m 2 IV or IM Day 2 Cycles 2, 4, 6 ARAC: 1,000 mg/m2, IV in 3 hours on days 1, 3 and 5

Study Type

Interventional

Enrollment (Anticipated)

100

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
      • Badalona, Barcelona, Spain
        • Recruiting
        • Hospital Germans Trias i Pujol and all Hospital Pethema

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

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 ALL with chromosome Ph 'negative and naïve

Exclusion Criteria:

  1. L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of Burkitt type (t [8, 14], t [2, 8], t [8, 22]).
  2. Biphenotypic acute leukemias and bilinear

  3. Acute undifferentiated leukemia

    The criteria for exclusion from treatment (but not patient record) any of the following:

  4. Patients with a history of severe and uncontrolled disease, including:

    • Coronary artery disease, valvular or hypertensive heart disease.
    • Chronic liver disease (active viral or alcoholic).
    • Chronic respiratory failure.
    • Renal failure not due to the ALL.
    • Serious neurological disorder not due to the ALL. f. Improperly controlled diabetes.
  5. General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), not attributable to the LAL.
  6. LAL chromosome Ph 'positive (must register even if you follow a specific protocol).
  7. Lack of consent by the patient to use their medical records.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chemotherapy
Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

General Publications

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)

June 30, 2007

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (ESTIMATE)

June 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAL-07OLD

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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