PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia (2009-009422-92)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00944008
First received: June 8, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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)

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: DepoCyte
Phase 3

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

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerability of IT DepoCyte [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 7
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   16 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944008

Locations
Spain
Hoapital General
Alicante, Spain
Hospital Duran i Reynals
Barcelona, Spain
Hospital Clínic
Barcelona, Spain
Hospital de Sant Pau
Barcelona, Spain
Hospital vall d'Hebrón
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Clínico
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital La Paz.
Madrid, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Morales Meseguer.
Murcia, Spain
Hospital Clínico Virgen de la Victoria
Málaga, Spain
Hospital Carlos Haya.
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
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Sancho Jose Manuel, Dr HOSPITAL GERMANS TRIAS I PUJOL
  More Information

Additional Information:
No publications provided

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00944008     History of Changes
Other Study ID Numbers: PRODECYTE
Study First Received: June 8, 2009
Last Updated: April 4, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia (ALL)
Depocyte®
Neuromeningeal relapse
Between 16 and 30 years old
Standard risk

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014