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

NCT00944008 | Terminated Phase 3 DMC

• 1 other identifier: PRODECYTE
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 17

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 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)

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia (ALL); Depocyte®; Neuromeningeal relapse; Between 16 and 30 years old; Standard risk

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (2)

• Tolerability of IT DepoCyte

  2 months

• 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

  2 years

Study Arms (1)

Depocyte

EXPERIMENTAL

Drug: DepoCyte

Interventions

DepoCyte DRUG

Depocyte

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (17)

Hoapital General

Alicante, Spain

Location

Hospital Clínic

Barcelona, Spain

Location

Hospital de Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Duran i Reynals

Barcelona, Spain

Location

Hospital vall d'Hebrón

Barcelona, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Clínico

Madrid, Spain

Location

Hospital La Paz.

Madrid, Spain

Location

Hospital Carlos Haya.

Málaga, Spain

Location

Hospital Clínico Virgen de la Victoria

Málaga, Spain

Location

Hospital Morales Meseguer.

Murcia, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Son Dureta.

Palma de Mallorca, Spain

Location

Hospital Clínico Universitario

Salamanca, Spain

Location

Hospital Universitario Virgen del Rocío.

Seville, Spain

Location

Hospital clínico Universitario

Valencia, Spain

Location

Related Links

• Spanish Asotiation of Hematology

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sancho Jose Manuel, Dr

  Germans Trias i Pujol Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: July 22, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 8, 2015

Record last verified: 2014-04

Locations

ES (17)