Adult ALLNCT06991920
Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage
A study testing Blinatumomab and Venetoclax in people with Adult ALL and MPAL, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- What is being tested?
- Blinatumomab and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 1 Apr 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immune-targeted Combination With Acute Lymphoblastic Leukemia-like Chemotherapy for Adult of Acute Leukemia of Ambiguous Lineage: A Prospective, Single-arm, Multicenter Clinical Study
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.
- Being tested
- Blinatumomab, Venetoclax
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
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.
VenetoclaxDrug
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 group | Role | What they receive |
|---|---|---|
| Systematic treatment strategy | Experimental | Integrate Blinatumomab, ALL-like chemotherapy, Venetoclax and TKI drugs into the systemic treatment plan Receives: Drug: Blinatumomab; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Used to evaluate all patients who enter clinical trials. From the date of entry into the trial until the date of patient death (including any cause) or last survival follow-up.
Measured: up to 2 years
Secondary outcomes (5)
Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate
Proportion of patients with CR, CRh or Cri
Measured: Six weeks after induction therapy
Flow cytometry for minimal residual disease（FCM-MRD） negativity rate at 3 months post-therapy
FCM-MRD is a method that detects residual trace leukemia or lymphoma cells in patients' bodies after treatment
Measured: 3 months after therapy
Relapse free survival(RFS)
The interval from CR to the date of relapse, or the date of death, or the date of last follow-up, whichever occurred first. This outcome analyzes patients achieved CR in two courses of induction therapy.
Measured: up to 2 years after the date of the last enrolled participants
Event-free survival (EFS)
The interval from the date of enrollment to the date of failed to achieve complete remission, the date of relapse, or the date of death, whichever occurred first.
Measured: up to 2 years after the date of the last enrolled participants
Disease-free Survival (DFS)
From CR1 to relapse, death from any cause or last follow-up
Measured: up to 2 years after the date of the last enrolled participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start30 Jun 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Wei, MD, Principal investigator, Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991920
- Sponsor's protocol ID
- IIT2024114
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No