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

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

NCT ID: NCT06507514

Condition: B-cell Acute Lymphoblastic Leukemia

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Blinatumomab

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: blinatumomab and auto-HSCT "sandwich " strategy
Description: The patients received sequential infusion of blinatumomab after standard induction and consolidation chemotherapy. Autologous stem cells mobilization and collection were performed 6-8 weeks after infusion. Following successful stem cell collection, autologous stem cell transplantation was conducted. Starting from the third month after autologous stem cell transplantation, the second maintenance treatment with brentuximab vedotin was administered, with one cycle every three months, for a total of four cycles. Patients were followed up and minimal residual diseases (MRD) was monitored by flow cytometry and second-generation gene sequencing of IgH rearrangement.
Arm group label: Blinatumomab and Auto-HSCT Sandwich Strateg

Summary: 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.

Detailed description: Enrolled patients received induction chemotherapy with the IVP regimen and two cycles of consolidation chemotherapy: high-dose cytarabine (Ara-c) + pegaspargase (± Tyrosine kinase inhibitors ,TKI) and methotrexate (MTX) + pegaspargase (± TKI). Sequential treatment with blinatumomab was then administered. After the first treatment with blinatumomab, autologous stem cell mobilization and collection were performed. Following successful stem cell collection, autologous stem cell transplantation was conducted. Starting from the third month after autologous stem cell transplantation, the second maintenance treatment with blinatumomab was administered, with one cycle every three months, for a total of four cycles. Long-term follow-up monitoring was then conducted. The follow-up period for this study was two years, and data on two-year LFS, OS, and NRM rates were collected.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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. - T-cell amplification test pass. - expected survival > 3 months. Exclusion Criteria: - 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. - HIV infection. - active hepatitis B or hepatitis C infection. - history of severe tachyphylaxis to aminoglycoside antibiotics. - history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

Gender: All

Minimum age: 15 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affliated Hospital of Soochow University

Address:
City: Suzhou
Zip: 215006
Country: China

Status: Recruiting

Contact:
Last name: Sheng-Li Xue, M.D.

Phone: +8651267781139
Email: slxue@suda.edu.cn

Start date: April 1, 2024

Completion date: April 1, 2030

Lead sponsor:
Agency: The First Affiliated Hospital of Soochow University
Agency class: Other

Source: The First Affiliated Hospital of Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06507514