Clin2
NCT03959085Possibly a fitRecruiting

Inotuzumab plus chemotherapy for high-risk childhood leukemia

B Acute Lymphoblastic LeukemiaB Lymphoblastic LymphomaCentral Nervous System LeukemiaMixed Phenotype Acute LeukemiaTesticular Leukemia

Treatments studied

Part of Blood & lymphatic, Cancer, Immune system & allergy, Infections clinical trials.

This Phase 3 trial tests whether adding inotuzumab to standard post-induction chemotherapy improves outcomes for children and young teens with high-risk B-ALL, mixed phenotype acute leukemia (MPAL), or certain high-risk B-LLy. It may help by targeting leukemia cells more directly, but participation depends on specific age, lab results, and medical history rules.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
5,951 people
Ages
12 months to 25 years
Study type
Interventional

Who can take part

  • You are between 1 and 24 years old (older than 365 days but under 25).
  • You have newly diagnosed B-ALL, MPAL, or B-LLy with specific “high-risk” features (including certain blast or marrow results).
  • Your initial white blood cell (WBC) blood counts meet the study rules based on your age, and/or special situations like testicle leukemia, CNS leukemia, or steroid pretreatment (for younger children).
  • You must get a check of fluid from around the brain/spine (CSF) before starting treatment to see if leukemia is present in the CNS.
  • Your liver blood tests must be within limits (direct bilirubin below 2.0 mg/dL, and ALT not more than 10 times the normal limit, with exceptions like Gilbert’s syndrome).
  • You (or your parent/guardian) must sign written informed consent, and study paperwork and testing required by the hospital and regulators must be completed.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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