PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia
Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphoblastic Leukemia
Intervention: DepoCyte (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: PETHEMA Foundation Official(s) and/or principal investigator(s): Sancho Jose Manuel, Dr, Study Chair, Affiliation: Germans Trias i Pujol Hospital
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)
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse
Secondary outcome: Tolerability of IT DepoCyteCompare 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
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
Eligibility
Minimum age: 16 Years.
Maximum age: 30 Years.
Gender(s): Both.
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
Locations and Contacts
Hoapital General, Alicante, Spain
Hospital ClÃnic, Barcelona, Spain
Hospital de Sant Pau, Barcelona, Spain
Hospital del Mar, Barcelona, Spain
Hospital Duran i Reynals, Barcelona, Spain
Hospital vall d'Hebrón, Barcelona, Spain
Hospital 12 de Octubre, Madrid, Spain
Hospital ClÃnico, Madrid, Spain
Hospital La Paz., Madrid, Spain
Hospital Morales Meseguer., Murcia, Spain
Hospital Virgen de la Arrixaca, Murcia, Spain
Hospital Carlos Haya., Málaga, Spain
Hospital ClÃnico Virgen de la Victoria, Málaga, Spain
Hospital Son Dureta., Palma de Mallorca, Spain
Hospital ClÃnico Universitario, Salamanca, Spain
Hospital Universitario Virgen del RocÃo., Sevilla, Spain
Hospital clÃnico Universitario, Valencia, Spain
Additional Information
Spanish Asotiation of Hematology
Starting date: September 2009
Last updated: May 7, 2015
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