Clinical Trials /

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

NCT01366898

Description:

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

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
  • Official Title: PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)

Clinical Trial IDs

  • ORG STUDY ID: LAL-07OLD
  • NCT ID: NCT01366898

Conditions

  • Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
Dexamethasona, Idarubicine, ARA-C, MethotrexateChemotherapy

Purpose

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

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
    

Trial Arms

NameTypeDescriptionInterventions
ChemotherapyExperimental
  • Dexamethasona, Idarubicine, ARA-C, Methotrexate

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:55 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy in terms of response rate
Time Frame:5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Efficacy in terms disease free survival
Time Frame:5 years
Safety Issue:
Description:
Measure:Efficacy in terms of global survival
Time Frame:10 years
Safety Issue:
Description:

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:PETHEMA Foundation

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