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

NCT06507514 | Recruiting Phase 1

• 1 other identifier: SZBALL02
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Overall survival（OS）

  It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

  4 years

• leukemia free survival（LFS）

  It is measured from the date of achievement of a remission until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.

  4 years

Secondary Outcomes (1)

• Number of adverse events

  4 years

Study Arms (1)

Blinatumomab and Auto-HSCT Sandwich Strateg

OTHER

Combination Product: blinatumomab and auto-HSCT "sandwich " strategy

Interventions

blinatumomab and auto-HSCT "sandwich " strategy COMBINATION_PRODUCT

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.

Blinatumomab and Auto-HSCT Sandwich Strateg

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)