NCT07921550Not yet recruiting
Venetoclax Plus Inotuzumab Reduced-Intensity Induction Sequentially Followed by Blinatumomab in B-ALL
A Prospective Single-Arm Study of Venetoclax Combined With Inotuzumab Ozogamicin Reduced-Chemotherapy Induction Sequentially Followed by Blinatumomab in Newly Diagnosed CD22-Positive Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
This prospective, open-label, single-arm study evaluates whether reduced-intensity induction with venetoclax plus inotuzumab ozogamicin (2VIP) followed by one cycle of blinatumomab improves the 8-week NGS-MRD-negative complete remission rate in adolescents and adults (age 14-60 years) with newly diagnosed, untreated, CD22-positive, Philadelphia chromosome-negative B-cell ALL. A Simon two-stage design will enroll up to 43 evaluable patients.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 2 Nov 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 1 May 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- NCT number
- NCT07921550
What you commit to
- Study type: Interventional
- Planned participants: 43
- From 30 Nov 2026 to the primary completion date, 1 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled active infection.
- History of pancreatitis.
- Active GI bleeding within 6 months. -
- Arterial/venous thrombosis within 6 months.
- Known HIV.
- Psychiatric disease precluding compliance.
- Other conditions judged unsuitable by the investigator.
Lab values
- Uncontrolled diabetes (HbA1c >7.5%).
Other
- Burkitt lymphoma/leukemia.
- Acute leukemia of ambiguous lineage.
- Pregnancy.
Who the study is looking for
- Newly diagnosed, untreated (except prednisone/hydroxyurea) Ph-negative ALL by morphology and immunophenotype.
- CD22-positive (≥20% blasts).
- Age ≥14 and ≤60 years.
- ECOG ≤2.
- Effective contraception if of childbearing potential.
- Organ function: TBIL <1.5×ULN; AST/ALT ≤2.5×ULN; creatinine <2×ULN; myocardial enzymes <2×ULN; amylase ≤1.5×ULN; LVEF >45%.
- Written informed consent.
Age in the registry: 14 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.