Acute Lymphoblastic LeukemiaPhase 4NCT00411541
Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia
A Phase 4 study testing vincristine and dexamethasone in people with Acute Lymphoblastic Leukemia, run by International BFM Study Group at 8 sites in 8 countries.
Trial summary
Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- vincristine and dexamethasone
- How many people
- 2,600 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Apr 1995to Jan 2004
- Phase
- Phase 4
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age <1 or >5 years or
- white blood cell count at diagnosis >=20000
Who cannot join
- prednisone poor response
- no complete remission at the end of induction (IA)
- t(9,22) clonal translocation
- t(4,11) clonal translocation
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Argentina1 site
Department of Pediatric Hematology-Oncology, Italian Hospital
Buenos Aires
Austria1 site
Children's Cancer Research Institute, St Anna Kinderspital
Vienna
Belgium1 site
Department of Pediatric Hemato-Oncology, Gent University Hospital
Ghent
Chile1 site
Department of Pediatrics Hematology and Oncology, Hospital Roberto del Rio
Santiago
Czechia1 site
Department of Pediatric Hematology and Oncology, University Hospital Motol
Prague
About this study
Official title: Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia
Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids. We aimed to investigate the efficacy and toxic effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase in a large cohort of children with intermediate-risk disease who were treated with the BFM treatment strategy
Read the detailed description
The study enrols children from 8 participating organizations. All children are treated with similar protocols based on the BFM treatment strategy, which include induction, consolidation, reinduction and continuation-therapy phases. At the beginning of the continuation-therapy phase, those patients in complete remission are randomly assigned to either a treatment or a control group. Control patients are given conventional mercaptopurine and methotrexate chemotherapy only. Patients in the treatment arm are also given pulses of vincristine (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- vincristine, dexamethasone
- Keywords
- acute lymphoblastic leukemia, maintenance, BFM protocol, intermediate risk childhood acute lymphoblastic leukemia
- 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.
vincristineDrug
dexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Secondary outcomes (1)
survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startApr 1995
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,600 participants
Sponsor and investigators
- Lead sponsor
- International BFM Study Group
- Sponsor type
- Research network
- Collaborators
- Associazione Italiana Ematologia Oncologia Pediatrica, BFM-A, Austria, BFM-G, Germany and Switzerland, CPH, Czech republic, European Organisation for Research and Treatment of Cancer - EORTC, Group for Acute Leukemia Treatment (GATLA)., H-POG (Hungary Pediatric Oncology Group), PINDA, Chile
- Investigators
- Martin Schrappe, MD, Principal investigator, BFM-G, Germany and SwitzerlandHelmut Gadner, MD, Principal investigator, BFM-A, AustriaGiuseppe Masera, MD, Principal investigator, AIEOP, ItlayJan Stary, MD, Principal investigator, CPH, Czech republicIves Benoit, MD, Principal investigator, EORTC-CLG, France, Belgium, PortugalEdina Magyarosy, MD, Principal investigator, H-POG (Hungary Pediatric Oncology Group)Myriam Campbell, MD, Principal investigator, PINDA, ChileEduardo Dibar, MD, Principal investigator, Group for Acute Leukemia Treatment (GATLA).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411541
- Sponsor's protocol ID
- I-BFM-SG IR ALL
- Status last verified
- Dec 2006
- First submitted
- 13 Dec 2006
- Last updated
- 14 Dec 2006
- Results posted
- No
Publications
Conter V, Valsecchi MG, Silvestri D, Campbell M, Dibar E, Magyarosy E, Gadner H, Stary J, Benoit Y, Zimmermann M, Reiter A, Riehm H, Masera G, Schrappe M. Pulses of vincristine and dexamethasone in addition to intensive chemotherapy for children with intermediate-risk acute lymphoblastic leukaemia: a multicentre randomised trial. Lancet. 2007 Jan 13;369(9556):123-31. doi: 10.1016/S0140-6736(07)60073-7.
PubMed 17223475
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulses of Vincristine and Dexamethasone During Maintenance in BFM Protocols for Children With Intermediate-Risk Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT00411541
- Acronym / sponsor ID
- I-BFM-SG IR ALL
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- acute lymphoblastic leukemia, maintenance, BFM protocol, intermediate risk childhood acute lymphoblastic leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,600 participants
- Lead sponsor
- International BFM Study GroupResearch network
- Collaborators
- Associazione Italiana Ematologia Oncologia Pediatrica, BFM-A, Austria, BFM-G, Germany and Switzerland, CPH, Czech republic, European Organisation for Research and Treatment of Cancer - EORTC, Group for Acute Leukemia Treatment (GATLA)., H-POG (Hungary Pediatric Oncology Group), PINDA, Chile
- Study start
- Apr 1995
- Study completion
- Jan 2004
- First posted
- 14 Dec 2006 (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.
Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids. We aimed to investigate the efficacy and toxic effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase in a large cohort of children with intermediate-risk disease who were treated with the BFM treatment strategy
Detailed description
The study enrols children from 8 participating organizations. All children are treated with similar protocols based on the BFM treatment strategy, which include induction, consolidation, reinduction and continuation-therapy phases. At the beginning of the continuation-therapy phase, those patients in complete remission are randomly assigned to either a treatment or a control group. Control patients are given conventional mercaptopurine and methotrexate chemotherapy only. Patients in the treatment arm are also given pulses of vincristine (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age <1 or >5 years or
- white blood cell count at diagnosis >=20000
Key exclusion criteria (4 listed)
- prednisone poor response
- no complete remission at the end of induction (IA)
- t(9,22) clonal translocation
- t(4,11) clonal translocation
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 |
|---|---|---|
| vincristine | Drug | – |
| dexamethasone | Drug | – |
Primary outcome
disease free survival
1 secondary outcome
survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2006.
- Derived from this study: PubMed 17223475Conter V, Valsecchi MG, Silvestri D, Campbell M, Dibar E, Magyarosy E, Gadner H, Stary J, Benoit Y, Zimmermann M, Reiter A, Riehm H, Masera G, Schrappe M. Pulses of vincristine and dexamethasone in addition to intensive chemotherapy for children with intermediate-risk acute lymphoblastic leukaemia: a multicentre randomised trial. Lancet. 2007 Jan 13;369(9556):123-31. doi: 10.1016/S0140-6736(07)60073-7.
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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.
Martin Schrappe, MD principal investigator
BFM-G, Germany and Switzerland
Helmut Gadner, MD principal investigator
BFM-A, Austria
Giuseppe Masera, MD principal investigator
AIEOP, Itlay
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vincristine and dexamethasone in people with Acute Lymphoblastic Leukemia, run by International BFM Study Group at 8 sites in 8 countries.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 14 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina, Austria, Belgium, Chile, Czechia and 3 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disease free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00411541, which also lists 1 linked publication.
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 14 Dec 2006.