PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia (2009-009422-92)

May 7, 2015 updated by: PETHEMA Foundation

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

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hoapital General
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clínic
      • Barcelona, Spain
        • Hospital Duran I Reynals
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Clinico
      • Madrid, Spain
        • Hospital La Paz.
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Murcia, Spain
        • Hospital Morales Meseguer.
      • Málaga, Spain
        • Hospital Carlos Haya.
      • Málaga, Spain
        • Hospital Clínico Virgen de la Victoria
      • Palma de Mallorca, Spain
        • Hospital Son Dureta.
      • Salamanca, Spain
        • Hospital Clinico Universitario
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocío.
      • Valencia, Spain
        • Hospital Clinico Universitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depocyte
Drug: DepoCyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability of IT DepoCyte
Time Frame: 2 months
2 months
Compare the frequency of relapse in CNS with an historic group of patients of identical risk that were treated with the PETHEMA LAL-RI/96 protocol
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Investigators

  • Study Chair: Sancho Jose Manuel, Dr, Germans Trias I Pujol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRODECYTE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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