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New treatment option for Acute Lymphoblastic Leukemia, Pediatric
Official title Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
ClinicalTrials.gov ID: NCT03643276
What this study is testing
What is Blinatumomab?
Blinatumomab is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for acute lymphoblastic leukemia, pediatric.
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 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.
- 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 up to 17
You may be able to join if
- 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...
- newly diagnosed acute undifferentiated leukemia
You likely can't join if
- 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...
See the full eligibility 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 turn out not to be fulfilled or in the case of pregnancy of the patient.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, Australia
- Westmead, Australia
- Graz, Austria
- Innsbruck, Austria
- Linz, Austria
- Salzburg, Austria
- Vienna, Austria
- Brno, Czechia
- České Budějovice, Czechia
- Hradec Králové, Czechia
- Olomouc, Czechia
- Ostrava-Poruba, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Ústí nad Labem, Czechia
- Aachen, Germany
- Augsburg, Germany
- Berlin, Germany
- Braunschweig, Germany
- Chemnitz, Germany
+ 88 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, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, Australia; Westmead, Australia; Graz, Austria; Innsbruck, Austria; Linz, Austria; Salzburg, Austria and 102 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.