Status:
TERMINATED
PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
16-30 years
Phase:
PHASE3
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 wi...
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 DepoC...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00944008
Start Date
September 1 2009
End Date
July 1 2012
Last Update
May 8 2015
Active Locations (17)
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1
Hoapital General
Alicante, Spain
2
Hospital Clínic
Barcelona, Spain
3
Hospital de Sant Pau
Barcelona, Spain
4
Hospital del Mar
Barcelona, Spain