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New treatment option for Acute Lymphoblastic Leukaemia
Official title Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
ClinicalTrials.gov ID: NCT01949129
What this study is testing
What is VP16?
VP16 is an investigational medicine, being studied as a potential treatment for acute lymphoblastic leukaemia.
Also referred to as Etoposide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
- age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
- indication for allogeneic HSCT
- complete remission (CR) before HSCT
- written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
You likely can't join if
- patients who do not fulfil the inclusion criteria
- Non Hodgkin-Lymphoma
- the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
- no consent is given for saving and propagation of anonymous medical data for study reasons
- severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes...
- Karnofsky / Lansky score \< 50%
See the full eligibility criteria
- Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
- age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
- indication for allogeneic HSCT
- complete remission (CR) before HSCT
- written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
- no pregnancy
- no secondary malignancy
- no previous HSCT
- HSCT is performed in a study participating centre
- patients who do not fulfil the inclusion criteria
- Non Hodgkin-Lymphoma
- the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
- no consent is given for saving and propagation of anonymous medical data for study reasons
- severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
- Karnofsky / Lansky score \< 50%
- people unwilling or unable to comply with the study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Argentina
- La Plata, Argentina
- Melbourne, Australia
- Perth, Australia
- Randwick, Australia
- South Brisbane, Australia
- Sydney, Australia
- Graz, Austria
- Innsbruck, Austria
- Vienna, Austria
- Minsk, Belarus
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Calgary, Canada
- Montral, Canada
- Montreal, Canada
- Toronto, Canada
- Vancouver, Canada
+ 89 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina; La Plata, Argentina; Melbourne, Australia; Perth, Australia; Randwick, Australia; South Brisbane, Australia and 103 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.