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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06991920
Status
Not Yet Recruiting

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Conditions

  • Adult ALL
  • MPAL

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab — DRUG
    CD19-positive, Ph+ patients with favorable financial status may receive VP + TKI + blinatumomab therapy；CD19-positive, Ph- patients with favorable financial status may receive VCP + blinatumomab therapy.
  • Venetoclax — DRUG
    CD19-positive, Ph+ patients with poor financial status may receive VP + TKI + VEN therapy；CD19-negative or CD19-positive, Ph- patients ineligible for blinatumomab may receive VPCLP + VEN therapy.

Study Details

Acute leukemia of ambiguous lineage (ALAL), which refers to acute leukemia without definite evidence indicating cell differentiation along a specific lineage, mainly encompasses two major categories: acute undifferentiated leukemia (AUL) lacking the expression of lineage-specific antigens and mixed phenotype acute leukemia (MPAL) expressing antigens of two or more lineages. Despite certain advancements in basic research on ALAL, there is currently no unified treatment protocol for this disease. The majority of clinical studies are based on retrospective data, lacking prospective cohort studies. In terms of the overall treatment strategy, given the low chemotherapy remission rate, frequent relapses, and poor prognosis of ALAL, it should be treated as high-risk acute leukemia. Patients achieving complete remission should undergo allogeneic hematopoietic stem cell transplantation as soon as possible if conditions permit. Regarding chemotherapy regimens, the current main regimens utilized in clinical practice include ALL-like regimens, AML-like regimens, and hybrid therapies that incorporate both lymphoid and myeloid lineages. Based on existing research, international consensus guidelines recommend ALL-like regimens as the preferred induction treatment option for ALAL patients. In recent years, novel immunotherapy antibody drugs, such as Blinatumomab (a CD19-targeted drug), have achieved remarkable success in the treatment of B-ALL. However, for CD19+ ALAL, there is a lack of effective data regarding whether the first-line application of immunotherapy can further enhance therapeutic efficacy. Simultaneously, the novel small molecule drug venetoclax has demonstrated favorable therapeutic effects on various hematological malignancies. To enhance the overall therapeutic efficacy of adult ALAL in China, based on the above research, we have formulated a comprehensive treatment plan for adult ALAL, integrating Blinatumomab, ALL-like chemotherapy, venetoclax, and TKI drugs into the systemic treatment regimen, and exploring the safety and efficacy of this regimen in the treatment of adult ALAL.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2025
Primary completion
Apr 1, 2030
Completion
Apr 1, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Systematic treatment strategy
    Integrate Blinatumomab, ALL-like chemotherapy, Venetoclax and TKI drugs into the systemic treatment plan

Primary Outcome Measure

overall survival (OS) [ Time Frame: up to 2 years ]

Central Contacts

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