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New treatment option for Acute Lymphoblastic Leukemia
Official title Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
ClinicalTrials.gov ID: NCT05327894
What this study is testing
What is Blinatumomab?
Blinatumomab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as Cycle 1.
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
- This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.
- Phase 3: a large, late-stage study
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 1
You may be able to join if
- Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and...
- ≤ 365 days of age at the time of diagnosis of ALL.
- Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.
You likely can't join if
- for blinatumomab:
- KMT2A-wildtype patients.
- Multilineage MPAL
- T-ALL.
- Age \> 365 days at the time of diagnosis.
- Down syndrome.
See the full eligibility criteria
- Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement.
- ≤ 365 days of age at the time of diagnosis of ALL.
- Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.
- for blinatumomab:
- KMT2A-wildtype patients.
- Multilineage MPAL
- T-ALL.
- Age \> 365 days at the time of diagnosis.
- Down syndrome.
- Relapsed ALL.
- Treatment with systemic corticosteroids (equivalent prednisone \>10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by...
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Argentina
- Clayton, Victoria, Australia
- Adelaide, Australia
- Clayton, Australia
- New Lambton Heights, Australia
- Parkville, Australia
- Perth, Australia
- South Brisbane, Australia
- Sydney, Australia
- Westmead, Australia
- Graz, Austria
- Innsbruck, Austria
- Salzburg, Austria
- Vienna, Austria
- Antwerp, Belgium
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Brno, Czechia
+ 94 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 day to 1 year. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Argentina; Clayton, Victoria, Australia; Adelaide, Australia; Clayton, Australia; New Lambton Heights, Australia; Parkville, Australia and 108 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.