Acute Lymphoblastic LeukemiaPhase 32009-009422-92NCT00944008
PROCEDYTE: Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration in Acute Lymphoblastic Leukemia
A Phase 3 study testing DepoCyte in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 17 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- DepoCyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 17 sitesSpain
- Study dates
- Sep 2009to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hoapital General
Alicante
Hospital Clínic
Barcelona
Hospital de Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Duran i Reynals
Barcelona
Hospital vall d'Hebrón
Barcelona
Hospital 12 de Octubre
Madrid
Hospital Clínico
Madrid
Hospital La Paz.
Madrid
Hospital Carlos Haya.
Málaga
Hospital Clínico Virgen de la Victoria
Málaga
Hospital Morales Meseguer.
Murcia
Hospital Virgen de la Arrixaca
Murcia
Hospital Son Dureta.
Palma de Mallorca
Hospital Clínico Universitario
Salamanca
Hospital Universitario Virgen del Rocío.
Seville
Hospital clínico Universitario
Valencia
About this study
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
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.
Read more
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)
Read the 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
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- DepoCyte
- Keywords
- Acute Lymphoblastic Leukemia (ALL), Depocyte®, Neuromeningeal relapse, Between 16 and 30 years old, Standard risk
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepoCyteDrug
| Study group | Role | What they receive |
|---|---|---|
| Depocyte | Experimental | Not described Receives: Drug: DepoCyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse
Measured: 1 year
Secondary outcomes (2)
Tolerability of IT DepoCyte
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sancho Jose Manuel, Dr, Study chair, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944008
- Sponsor's protocol ID
- PRODECYTE
- Acronym
- 2009-009422-92
- Status last verified
- Apr 2014
- First submitted
- 8 Jun 2009
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00944008
- Acronym / sponsor ID
- 2009-009422-92 / PRODECYTE
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia (ALL), Depocyte®, Neuromeningeal relapse, Between 16 and 30 years old, Standard risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depocyte | Experimental | Drug: DepoCyte |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DepoCyte | Drug | Depocyte |
Primary outcome
Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse
Time frame: 1 year
2 secondary outcomes
Tolerability of IT DepoCyte
Time frame: 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
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Spanish Asotiation of HematologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sancho Jose Manuel, Dr study chair
Germans Trias i Pujol Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DepoCyte in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 17 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.