NCT03643276 Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
| NCT ID | NCT03643276 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Martin Schrappe |
| Condition | Acute Lymphoblastic Leukemia, Pediatric |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2018-07-15 |
| Primary Completion | 2028-07-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 5,000 participants in total. It began in 2018-07-15 with a primary completion date of 2028-07-14.
⚠ 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 understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response ("minimal residual disease \[MRD\] tests") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse. The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.
Eligibility Criteria
Inclusion Criteria: * newly diagnosed acute lymphoblastic leukemia or * newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria: * biphenotypic with a dominant T or B lineage assignment * bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen * newly diagnosed acute undifferentiated leukemia * age \< 18 years (up to 17 years and 365 days) at the day of diagnosis * patient enrolled in a participating center * written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient. Exclusion Criteria: * Ph+ (BCR-ABL1 or t(9;22)-positive) ALL * bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset * pre-treatment with cytostatic drugs * glucocorticoid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis * treatment started according to another protocol * underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…) * ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy * evidence of pregnancy or lactation period * Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy * participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor * live vaccine immunization within 2 weeks before start of protocol treatment
Contact & Investigator
Martin Schrappe, MD
PRINCIPAL INVESTIGATOR
Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel
Frequently Asked Questions
Who can join the NCT03643276 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Acute Lymphoblastic Leukemia, Pediatric. 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 NCT03643276 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 5,000 participants.
Is NCT03643276 currently recruiting?
Yes, NCT03643276 is actively recruiting participants. Contact the research team at a.moericke@pediatrics.uni-kiel.de for enrollment information.
Where is the NCT03643276 trial being conducted?
This trial is being conducted at Sydney, Australia, Westmead, Australia, Graz, Austria, Innsbruck, Austria and 11 additional locations.
Who is sponsoring the NCT03643276 clinical trial?
NCT03643276 is sponsored by Martin Schrappe. The principal investigator is Martin Schrappe, MD at Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel. The trial plans to enroll 5,000 participants.
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