NCT01949129 Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
| NCT ID | NCT01949129 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | St. Anna Kinderkrebsforschung |
| Condition | Acute Lymphoblastic Leukaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2013-04 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,800 participants in total. It began in 2013-04 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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% * subjects unwilling or unable to comply with the study procedures
Contact & Investigator
Christina Peters, Prof. MD PhD
STUDY CHAIR
St. Anna Kinderspital, Vienna, Austria
Frequently Asked Questions
Who can join the NCT01949129 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Acute Lymphoblastic Leukaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01949129 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT01949129 currently recruiting?
Yes, NCT01949129 is actively recruiting participants. Contact the research team at christina.peters@stanna.at for enrollment information.
Where is the NCT01949129 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, La Plata, Argentina, Melbourne, Australia, Perth, Australia and 11 additional locations.
Who is sponsoring the NCT01949129 clinical trial?
NCT01949129 is sponsored by St. Anna Kinderkrebsforschung. The principal investigator is Christina Peters, Prof. MD PhD at St. Anna Kinderspital, Vienna, Austria. The trial plans to enroll 1,800 participants.