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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
DepoCyte
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lymphoblastic Leukemia focused on measuring Acute Lymphoblastic Leukemia (ALL), Depocyte®, Neuromeningeal relapse, Between 16 and 30 years old, Standard risk

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hoapital General
  • Hospital Clínic
  • Hospital de Sant Pau
  • Hospital del Mar
  • Hospital Duran i Reynals
  • Hospital vall d'Hebrón
  • Hospital 12 de Octubre
  • Hospital Clínico
  • Hospital La Paz.
  • Hospital Morales Meseguer.
  • Hospital Virgen de la Arrixaca
  • Hospital Carlos Haya.
  • Hospital Clínico Virgen de la Victoria
  • Hospital Son Dureta.
  • Hospital Clínico Universitario
  • Hospital Universitario Virgen del Rocío.
  • Hospital clínico Universitario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Depocyte

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerability of IT DepoCyte
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

Full Information

First Posted
June 8, 2009
Last Updated
May 7, 2015
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00944008
Brief Title
PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia
Acronym
2009-009422-92
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Acute Lymphoblastic Leukemia (ALL), Depocyte®, Neuromeningeal relapse, Between 16 and 30 years old, Standard risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depocyte
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DepoCyte
Primary Outcome Measure Information:
Title
Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Tolerability of IT DepoCyte
Time Frame
2 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sancho Jose Manuel, Dr
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hoapital General
City
Alicante
Country
Spain
Facility Name
Hospital Clínic
City
Barcelona
Country
Spain
Facility Name
Hospital de Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Duran i Reynals
City
Barcelona
Country
Spain
Facility Name
Hospital vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clínico
City
Madrid
Country
Spain
Facility Name
Hospital La Paz.
City
Madrid
Country
Spain
Facility Name
Hospital Morales Meseguer.
City
Murcia
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Carlos Haya.
City
Málaga
Country
Spain
Facility Name
Hospital Clínico Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Son Dureta.
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío.
City
Sevilla
Country
Spain
Facility Name
Hospital clínico Universitario
City
Valencia
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://aehh.org
Description
Spanish Asotiation of Hematology

Learn more about this trial

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

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