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New treatment option for Acute Lymphoblastic Leukemia ALL
Official title Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
ClinicalTrials.gov ID: NCT06764238
What this study is testing
What is Blinatumomab (Group A)?
Blinatumomab (Group A) is an investigational medicine, being studied as a potential treatment for acute lymphoblastic leukemia all.
Also referred to as high-dose methotrexate.
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
- Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore: 1.
- 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 1 to 18
You may be able to join if
- Age older than 1 month to younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Diagnosis of B-ALL by immunophenotyping.
You likely can't join if
- Low-risk ALL
- sIgM+
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
- ALL evolved from chronic myeloid leukemia (CML).
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Secondary leukemia
See the full eligibility criteria
- Age older than 1 month to younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Diagnosis of B-ALL by immunophenotyping.
- Low-risk ALL
- sIgM+
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
- ALL evolved from chronic myeloid leukemia (CML).
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Secondary leukemia
- Known underlying congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency.
- Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Qingdao, Shandong, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Chongqing, China
- Shanghai, China
- Shenzhen, China
- Hong Kong, Hong Kong
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 month to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Guiyang, Guizhou, China; Wuhan, Hubei, China and 13 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.