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

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: Cytarabine

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