Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age15-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main method potentially curing adult B-ALL, but the high treatment-related mortality (NRM) affects overall survival (OS). Autologous stem cell transplantation (auto-HSCT) can significantly reduce NRM but has a higher relapse rate. Studies have confirmed that achieving MRD negativity before Auto-HSCT can effectively reduce post-transplant relapse, achieving similar efficacy to allo-HSCT. The efficacy of blinatumomab in clearing MRD has been confirmed. Therefore, using blinatumomab combined with Auto-HSCT for B-ALL patients seems to make it possible to achieve benefits in leukemia free survival(LFS) and OS. The investigators first conducted blinatumomab and auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.

Eligibility criteria

Qualifiers

subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.

positive expression of CD19 in peripheral blood or bone marrow primary cells detected by flow cytometry.

ardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation > 91% without oxygenation.

subjects aged 15-65 years (including 15 and 65 years), regardless of gender.

Disqualifiers

patients with recurrence of only isolated extramedullary lesions. combination of other malignant tumors.

previously treated with anti-CD19 therapies.

immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent.

uncontrolled active infections.

Trial design

Treatments tested in this trial

  • blinatumomab and auto-HSCT "sandwich " strategy

Treatment groups

4 Participants
are divided into 1 treatment group