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New treatment option for Acute Lymphoblastic Leukemia, Pediatric
Official title Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)
ClinicalTrials.gov ID: NCT05029531
What this study is testing
What is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors.?
the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. is an investigational medicine, given as an once-weekly 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 innovation of this protocol is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. Investigators have proposed a two-stage stratification into risk groups: Initially: Standard risk: patients with no rearrangement of the KMT2A gene.
- 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 365
You may be able to join if
- Age at diagnosis at 1 to 365 days of life.
- The start of induction therapy within a time interval of study recruitment phase.
- The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow (see...
- Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this study.
You likely can't join if
- The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;
- There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic...
- There is a lack of important data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol...
- The patient was treated before for a long time with cytotoxic drugs;
- There were treatment deviations not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Samory-Mashela,1, Russia
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 365 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Samory-Mashela,1, Russia. 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.