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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


Phase 3
16 Years
30 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Sancho Jose Manuel, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

HOSPITAL GERMANS TRIAS I PUJOL

Authority:

Spain: Ministry of Health

Study ID:

PRODECYTE

NCT ID:

NCT00944008

Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia (ALL)
  • Depocyte®
  • Neuromeningeal relapse
  • Between 16 and 30 years old
  • Standard risk
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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