New combo aims to keep leukemia from coming back after transplant
NCT ID NCT07199855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether giving two drugs—blinatumomab and venetoclax—after a stem cell transplant can prevent relapse in adults with high-risk B-cell acute lymphoblastic leukemia (B-ALL). The study enrolls 24 people aged 14 to 65. The main goal is to see how many stay cancer-free for two years after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- blinatumomab and venetoclax
- What this could lead to
- If successful, this combination could help prevent leukemia from returning after a stem cell transplant, improving long-term survival for high-risk patients.
- What could go wrong
- This is a small, early-phase study with only 24 participants, so results may not apply to everyone. The drugs can cause serious side effects like infections or nerve problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Demographics : Patients aged 14-65 years, regardless of gender or race. * Diagnosis : Confirmed Ph-negative acute B-cell lymphoblastic leukemia (Ph- B-ALL) through bone marrow cytomorphology, cytochemistry, immunophenotyping, chromosomal analysis, and genetic mutation testing, with CD19 surface antigen expression. * Risk Stratification : High-risk B-ALL (per NCCN 2024.V2 guidelines) or Standard-risk B-ALL with no pre-transplant remission or Standard-risk B-ALL in first complete remission (CR1) with measurable residual disease (MRD) positivity or Standard-risk B-ALL with ≥CR2 or B-ALL patients receiving reduced-intensity or non-myeloablative conditioning. * Transplant Eligibility : Scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a suitable donor meeting: HLA-identical sibling donor or Unrelated donor (HLA 9-10/10 high-resolution matched) or Haploidentical related donor. * HCT-CI Score : ≤2 (Hematopoietic Cell Transplantation-Specific Comorbidity Index). * ECOG Performance Status : ≤2. * Organ Function : Serum creatinine ≤1.5×ULN Cardiac ejection fraction ≥50% Baseline SpO₂ \>92% Total bilirubin ≤1.5×ULN; ALT/AST ≤2.0×ULN Pulmonary DLCO (hemoglobin-adjusted) ≥40% and FEV1 ≥50% * Post-Transplant Recovery : Full donor chimerism Platelet count \>50×10⁹/L Absolute neutrophil count \>1.0×10⁹/L Hemoglobin \>80g/L - Informed Consent : Patient and legal guardian must provide written informed consent, comply with treatment protocols, follow-up visits, and laboratory assessments. Exclusion Criteria: * Prior Malignancy : History of malignancy other than acute lymphoblastic leukemia within 5 years, except for adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical resection, or ductal carcinoma in situ post-resection. * MRD-Negative B-ALL : Standard-risk B-ALL with MRD-negative status pre-transplant (per NCCN 2024.V2). * Disease Activity : Relapse of primary disease or CR/MRD positivity (≥0.01%) confirmed by bone marrow re-evaluation within 1 week before maintenance therapy. * T-Cell Deficiency : Absolute CD3+ T-cell count ≤0.5×10⁹/L prior to maintenance therapy. * Active GVHD : Concurrent acute/chronic GVHD requiring systemic immunosuppressive treatment. * Unstable Systemic Diseases : Including but not limited to: * Unstable angina or cerebrovascular accident/transient ischemic attack (within 3 months) * Myocardial infarction (within 3 months) * Congestive heart failure (NYHA Class ≥ III) * Post-pacemaker implantation with severe arrhythmia requiring medication * Uncontrolled hepatic/renal/metabolic diseases * Pulmonary hypertension * Active Infection : Uncontrolled infections requiring intravenous antibiotics. HIV : Positive human immunodeficiency virus status. Hepatitis : Active HBV/HCV requiring antiviral therapy. * Psychiatric Conditions : Mental disorders or inability to provide informed consent. * Substance Abuse : Drug addiction or chronic alcoholism affecting trial evaluation. * Reproductive Status : Pregnant/breastfeeding females Fertile patients unwilling to use contraception during treatment and 12 months post-treatment \- Other : Conditions deemed inappropriate by investigators.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
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