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ALL SCTped 2012 FORUM - Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia
EU CTIS ID: 2024-512657-24-00
What this study is testing
Stratum 1 – randomised question (closed in December 2018, randomised patients in active follow-up): To show that a non-total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or an HLA matched donor (MD). Stratum 1 – MSD/MD: To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire cohort (question 3 and 5). Stratum 1 – MSD/MD in age-group 2-4 years: To explore incidence of adverse events of special interest (AESIs) and short-term overall survival and event free survival in the entire cohort receiving TBI/VP16 conditioning regimen. Stratum 2 – MMD: To explore event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:
- Age at diagnosis ≤ 18 years OR age at HSCT ≤ 21 years
- Indication for allogeneic HSCT
- Complete remission (CR) before SCT
- Written consent of the parents (legal guardian) and, if necessary, the minor patient via “Informed Consent Form”
- No pregnancy
You likely can't join if
- Patients who do not fulfil the inclusion criteria
- Non-Hodgkin Lymphoma
- Whole protocol and/or its essential parts are refused either by the 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; renal impairment (< 30% of normal glomerular filtration rate); severe pulmonary, hepatic or cardiac impairment due to toxicity or infection
- Karnofsky / Lansky score < 50%
See the full eligibility criteria
- All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:
- Age at diagnosis ≤ 18 years OR age at HSCT ≤ 21 years
- Indication for allogeneic HSCT
- Complete remission (CR) before SCT
- 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
- Whole protocol and/or its essential parts are refused either by the 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; renal impairment (< 30% of normal glomerular filtration rate); severe pulmonary, hepatic or cardiac impairment due to toxicity or infection
- Karnofsky / Lansky score < 50%
- Subjects unwilling or unable to comply with the study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Argentina
- Switzerland
- Belarus
- Mexico
- Israel
- Saudi Arabia
- Canada
- New Zealand
- Chile
- Malaysia
- Australia
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Argentina; Switzerland; Belarus; Mexico; Israel and 6 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 EU CTIS; the study team decides eligibility.