Clinical Trials /

Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years

NCT01376427

Description:

This study proposes to provide adequate treatment and is based on current scientific evidence for elderly patients with ALL Bcr / Abl positive. To determine whether low-dose chemotherapy associated with imatinib or dasatinib has acceptable tolerability in elderly patients. To determine whether this association can increase the rate and quality of referrals to the results of the literature of imatinib as monotherapy for elderly patients

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
  • Official Title: PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS

Clinical Trial IDs

  • ORG STUDY ID: LAL-07OPH
  • NCT ID: NCT01376427

Conditions

  • Acute Lymphoblastic Leukemia Ph Positive

Interventions

DrugSynonymsArms
Dexamethasone
Methotrexate
Vincristine

Purpose

This study proposes to provide adequate treatment and is based on current scientific evidence for elderly patients with ALL Bcr / Abl positive. To determine whether low-dose chemotherapy associated with imatinib or dasatinib has acceptable tolerability in elderly patients. To determine whether this association can increase the rate and quality of referrals to the results of the literature of imatinib as monotherapy for elderly patients

Detailed Description

      Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1).

      Intrathecal treatment (diagnosis and prophylactic / therapeutic) -5 days:

      Methotrexate 12 mg

      Systemic treatment:

        -  Imatinib 400 mg daily and continuous VO.

        -  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 prophase and
      induction):

      MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg

      Maintenance during the first year will start after full recovery after induction and after
      complete reassessment of the disease (including mielograma and Bcr-Abl/Abl or Bcr-Abl/Gus
      ratio in peripheral blood) and will last until one year from the time of complete remission.

      The basic treatment included imatinib 400 mg / day (or dasatinib), mercaptopurine at doses of
      50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly.

      One week every 3 months maintenance treatment added 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 treatment of 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.

      Maintenance treatment of third year During the third year after complete remission imatinib
      administered alone (or dasatinib
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        Inclusion Criteria:

        Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl
        positive) and previously untreated

        Exclusion Criteria:

          1. Other LAL negative for t (9; 22) and Bcr / Abl.

          2. biphenotypic acute leukemias or bilinear with t (9; 22).

          3. blast crisis of chronic myeloid leukemia progression during or after polychemotherapy
             treatment (including allo-BMT) or with inhibitors of tyrosine kinases.

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

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

          5. Lack of consent by the patient to use their clinical d
      
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:Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination
Time Frame:1 year
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:PETHEMA Foundation

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