PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia

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Brief Title

PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia

Official Title

PROCEDYTE: An Open, Prospective, Multicentre Clinical Trial With Historic Control to Determine Efficacy and Safety of Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration of Patients Between 16 and 30 Years Old With Standard Risk Acute Lymphoblastic Leukemia (ALL

Brief Summary

      The primary objective is:

        -  To determine the efficacy and safety of DepoCyte®, as the only intrathecal (IT)
           prophylaxis of neuromeningeal relapse for patients between 16 and 30 years old diagnosed
           with acute lymphoblastic leukemia of standard risk treated with the PETHEMA LAL-RI-08
           Protocol Chemotherapy schedule.

      The secondary objectives are:

        -  To evaluate the tolerability of IT DepoCyte® as CNS prophylaxis of CNS via IT for
           patients between 16 and 30 years old with ALL of standard risk.

        -  To compare the frequency of relapse in CNS for patients between 16 and 30 years old with
           standard risk ALL treated with the PETHEMA LAL-RI-08 Protocol Chemotherapy schedule and
           receiving DepoCyte® as the only IT CNS prophylaxis, with that observed in an historic
           group of patients of identical risk that were treated with the PETHEMA LAL-RI/96
           protocol (same systemic chemotherapy and double administration of triple intrathecal
           chemotherapy)

        -  To evaluate the frequency of systemic relapses of standard risk ALL patients between 16
           and 30 years old treated with the PETHEMA LAL-RI-08 Protocol and who receive DepoCyte®
           as the only IT prophylaxis of CNS involvement and to compare with those observed in the
           identical risk patients treated with PETHEMA LAL-RI/96 protocol (same systemic
           chemotherapy and double administration of triple IT chemotherapy)
    

Detailed Description

      A total of 85 patients between 16 and 30 years old with ALL of standard risk will be included
      in the study. The aim of this study is to determine the efficacy and safety of the
      administration of DepoCyte® as the only IT prophylaxis of the neuromeningeal relapse in
      patients between 16 and 30 years old diagnosed with ALL of standard risk.

      The study is divided in:

      Screening: 2 weeks before treatment Treatment: 2 years of systemic treatment according to
      PETHEMA LAL-RI-08 Protocol (Induction, Consolidation 1 and 2, Maintenance-1 with reinductions
      and maintenance 2 with no reinductions). Patients will receive DepoCyte® in Induction,
      Consolidation 1 and 2 and Maintenance 1 (first year). Patients will not receive DepoCyte® in
      Maintenance-2 (second year).

      Follow-up: Patients in the study will be followed up for one year
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse

Secondary Outcome

 Tolerability of IT DepoCyte

Condition

Acute Lymphoblastic Leukemia

Intervention

DepoCyte

Study Arms / Comparison Groups

 Depocyte
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

7

Start Date

September 2009

Completion Date

July 2012

Primary Completion Date

July 2012

Eligibility Criteria

        Inclusion Criteria:

          -  According to the investigator opinion, patient must able to carry out with all the
             clinical trial requirements

          -  Patient or Legal Representative must volunteer sign the inform consent before any
             study specific test, that is not part of the common patient attention, is performed.

          -  Age 16 to 30

          -  Patient diagnosed with standard risk ALL no previously treated. Standard risk ALL is
             defined by the following criteria:

          -  Leukocyte count < 25x109/L

          -  Absence of poor prognosis cytogenetic abnormalities:

             t(9;22) or demonstration of BCR-ABL rearrangements. 11q23 alterations or demonstration
             of ALL1-AF4 rearrangements.

          -  Childbearing women must have a negative pregnancy test and must accept to use an
             effective contraception method.

        Exclusion Criteria:

          -  CNS involvement at diagnosis, defined as presence of blasts in a centrifugated sample
             of craneospinal fluid with a cellular count of more than 5 cels/L, in the absence of
             traumatic puncture (more than 10 red blood cels/ml), or as neurological symptoms that
             suggest of neuromeningeal involvement and imaging tests compatible, in the absence of
             blasts in craneospinal fluid.

          -  B mature cell phenotype (sIg+) or with the Burkitt ALL cytogenetic abnormalities
             (t[8;14], t[2;8], t[8;22])

          -  ALL with t(9;22) or BCR-ABL rearrangements.

          -  Acute biphenotypic and bilineal leukemias

          -  Acute undifferentiated leukemia

          -  History of coronary or valvular disease or hypertensive cardiopathy

          -  Chronic hepatopathy

          -  Chronic respiratory insufficiency

          -  Chronic renal insufficiency not due to ALL

          -  Serious neurological disorders not due to ALL

          -  Abnormal ECOG (WHO scale grade 3 and 4) not done by ALL

          -  Pregnant or currently breast feeding women

          -  Patients participating in other clinical trial or receiving any other investigational
             agent within 30 days previous to the study inclusion
      

Gender

All

Ages

16 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Sancho Jose Manuel, Dr, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00944008

Organization ID

PRODECYTE


Responsible Party

Sponsor

Study Sponsor

PETHEMA Foundation


Study Sponsor

Sancho Jose Manuel, Dr, Study Chair, Germans Trias i Pujol Hospital


Verification Date

April 2014