Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Plain-language summary

This study evaluates a treatment protocol that includes Blinatumomab and Venetoclax for newly diagnosed intermediate/high-risk childhood B-cell acute lymphoblastic leukemia (B-ALL). Children older than 1 month and younger than 18 with B-ALL confirmed by bone marrow examination and immunophenotyping can take part. It is a Phase 2/Phase 3 study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE2/PHASE3

Status

Recruiting

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Intervention

Blinatumomab (Group A), Venetoclax (nonRand Group), Blinatumomab (Group B)

Start date

1/3/2025

Estimated completion

6/1/2031

Countries

China, Hong Kong

Related genes

Locations

• Hefei, China
• Hefei, China
• Fuzhou, China
• Guangzhou, China
• Guangzhou, China
• Nanning, China
• Guiyang, China
• Wuhan, China
• Wuhan, China
• Wuhan, China
• Changsha, China
• Changsha, China
• Nanjing, China
• Suzhou, China
• Nanchang, China
• Jinan, China
• Qingdao, China
• Xi’an, China
• Chengdu, China
• Tianjin, China
• Chongqing, China
• Shanghai, China
• Shanghai, China
• Shanghai, China
• Shenzhen, China
• Hong Kong, Hong Kong

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Age older than 1 month to younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of B-ALL by immunophenotyping.

Exclusion Criteria:

1. Low-risk ALL
2. sIgM+
3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
4. ALL evolved from chronic myeloid leukemia (CML).
5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
6. Secondary leukemia
7. Known underlying congenital immunodeficiency or metabolic disease
8. Congenital heart disease with cardiac insufficiency.
9. 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 radiotherapy to relieve airway compression)