Blinatumomab Combined With Venetoclax as Maintenance Therapy After Allo-HSCT in High-risk Ph Nega… (NCT07199855) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Blinatumomab Combined With Venetoclax as Maintenance Therapy After Allo-HSCT in High-risk Ph Negative Acute B-cell Lymphoblastic Leukemia
China24 participantsStarted 2025-06-01
Plain-language summary
This study is a single-center, single-arm, prospective clinical trial evaluating the efficacy and safety of blinatumomab combined with venetoclax as maintenance therapy for high-risk Philadelphia chromosome-negative acute B-cell lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation .
Who can participate
Age range14 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pr…
What they're measuring
1
the 2-year progression-free survival (PFS) rate post-transplantation
Timeframe: the 2-year progression-free survival (PFS) rate post-transplantation