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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 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

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 Clínic, 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 Clínico, 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 Clínico Virgen de la Victoria, Málaga, Spain

Hospital Son Dureta., Palma de Mallorca, Spain

Hospital Clínico Universitario, Salamanca, Spain

Hospital Universitario Virgen del Rocío., Sevilla, Spain

Hospital clínico Universitario, Valencia, Spain

Additional Information

Spanish Asotiation of Hematology

Starting date: September 2009
Last updated: May 7, 2015

Page last updated: August 20, 2015

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