PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

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Brief Title

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Official Title

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Brief Summary

      The objective of current protocol is try improve the results of chemotherapy treatment in
      patients with ALL wich is not indicated the peripheral stem cell transplant in first
      remission, with an intensive consolidation follow by re-inductions.
    

Detailed Description

      Induction therapy:

      Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and
      22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day,
      days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to
      12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate,
      cytosine arabinoside and hydrocortisone, days 1 to 22.

      Patients older than 55 years are not treated with asparaginase and cyclophosphamide.

      Consolidation therapy (1):

      Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate
      (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C
      (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

      Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and
      56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV
      days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment,
      days 1, 28 and 56.

      Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week
      after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5
      mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2
      IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase:
      10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15

      Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and
      methotrexate) and reinductions until one year from diagnosis.

        -  Continuous chemotherapy:

             -  MP 50 mg/m2/day PO

             -  MTX 20 mg/m2/week IM

        -  Reinductions

             -  VCR: 1,5 mg/m2 IV, day 1.

             -  PDN: 60 mg/m2/day, IV or PO days 1 to 7

             -  L-ASA: 20.000 UI/m2, IM or IV day 1.

             -  Intrathecally day 1

      Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.

      Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and
      methotrexate) while second year from diagnosis (weeks 53 to 104).

        -  MP 50 mg/m2/day, PO

        -  MTX 20 mg/m2/week, IM.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia

Secondary Outcome

 Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy

Condition

Acute Lymphoblastic Leukemia

Intervention

Asparaginase


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

374

Start Date

June 1996

Completion Date

December 2007

Primary Completion Date

May 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy

        Exclusion Criteria:

          -  Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14],
             t[2;8], t[8;22])

          -  Mixed forms of ALL

          -  Acute Leukemia no differentiate

          -  Patients with coronary disorders, valvular or hypertensive cardiopathy

          -  Patients with chronic liver disorders

          -  Chronic pulmonary disorders

          -  Renal insufficiency

          -  Neurologic disfunctions

          -  ECOG 3 and 4

          -  No signed consent form
      

Gender

All

Ages

15 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ribera Josep Mª, Dr, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00494897

Organization ID

LAL-RI/96



Study Sponsor

PETHEMA Foundation


Study Sponsor

Ribera Josep Mª, Dr, Study Director, Germans Trias i Pujol Hospital


Verification Date

May 2009