Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · May 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with a rare form of leukemia called acute leukemia of ambiguous lineage (ALAL). This type of leukemia can be challenging to treat because it doesn’t fit neatly into the usual categories and often has a poor response to standard chemotherapy. The researchers will be testing a combination of traditional chemotherapy, immunotherapy (a treatment that helps the immune system fight cancer), and other targeted drugs to see if this can improve treatment outcomes for patients.

To participate in this trial, individuals must be at least 14 years old and have been diagnosed with ALAL. They should have a good level of health, meaning they can perform daily activities with minimal assistance. Participants will be closely monitored throughout the study and will need to provide consent to take part. It's important to note that those with serious other health issues, pregnant or breastfeeding women, and individuals with certain infections will not be eligible for this trial. This study aims to find a more effective treatment strategy for ALAL, which could ultimately help improve survival rates and quality of life for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A series of acute leukemia of unknown origin diagnosed in accordance with the 5th edition of the WHO or ICC classification standards.
• • Age ≥ 14 years old, regardless of gender.
• • The ECOG performance status score is ≤ 2.
• • Conform to the following organ functional status: total bilirubin \< 1.5×ULN, AST and ALT ≤ 2.5×ULN; blood Cr \< 1.5×ULN; myocardial enzymes \< 2×ULN; serum amylase ≤ 1.5×ULN; echocardiography indicates that the left ventricular ejection fraction (LEF) \> 50%. (In the case of patients without a previous history of liver or kidney basic disease, if liver and kidney function abnormalities exceed the aforementioned inclusion criteria and the researcher determines that the liver and kidney function abnormalities are caused by acute leukemia itself, they may be included in the group at the researcher's discretion).
• • Understand and sign the informed consent form and agree to abide by the research requirements.
• Exclusion Criteria:
• • Concurrent with other serious and/or uncontrollable underlying diseases: accompanied by other malignant diseases requiring treatment, acute or chronic hepatitis, severe pancreatic or kidney diseases; other serious and/or life-threatening underlying diseases.
• • Pregnant or lactating women.
• • Positive for anti-HIV test.
• • Mental disorders that may prevent the subject from completing the treatment or giving informed consent.
• • The investigator deems the subject unsuitable for inclusion.