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

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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)

Brief Summary

      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
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Efficacy in terms of response rate

Secondary Outcome

 Efficacy in terms disease free survival

Condition

Acute Lymphoblastic Leukemia

Intervention

Dexamethasona, Idarubicine, ARA-C, Methotrexate

Study Arms / Comparison Groups

 Chemotherapy
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

May 2010

Completion Date

December 2019

Primary Completion Date

December 2018

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.
      

Gender

All

Ages

55 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT01366898

Organization ID

LAL-07OLD


Responsible Party

Sponsor

Study Sponsor

PETHEMA Foundation


Study Sponsor

, , 


Verification Date

May 2019