Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia

NCT07105579 | Recruiting Phase 2

• 1 other identifier: ZJU-HSCT-BITEDLI
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia

Conditions

Leukemia; Relapse

Keywords

hematopoietic stem cell transplantation; Blinatumomab; Donor Lymphocyte Infusion; Ph negative B cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• The 2-year leukemia-free survival (LFS) after allo-HSCT.

  2 years

Secondary Outcomes (3)

• The 2-year overall survival（OS）

  2 years

• The 2-year cumulative incidence of relapse

  2-years

• The 2-year cumulative incidence of non-relapse mortality(NRM)

  2-years

Study Arms (1)

Blinatumomab and Donor Lymphocyte Infusion

EXPERIMENTAL

Drug: BITE and DLI

Interventions

BITE and DLI DRUG

Blinatumomab dosage: Cycle 1 (starting at day 60 post-transplant):Days 1-3: 9 μg/day，Days 4-14: 28 μg/day Cycles 2-4:Days 1-14: 28 μg/day Administration method: Continuous 24-hour intravenous infusion, one cycle every 3 months. DLI eligibility criteria:No history of grade III-IV acute GVHD (aGVHD).No active aGVHD or chronic GVHD (cGVHD) at the time of infusion DLI dosage:Administered at day 120 post-HSCT, CD3+ cell dose: 1 × 10⁷/kg

Blinatumomab and Donor Lymphocyte Infusion

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 14-65 years (inclusive), regardless of gender.
• Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
• Ph-negative B-ALL with high-risk features post-allo-HSCT .
• ≥2 months post-transplant with hematopoietic reconstitution.
• Bone marrow morphology in remission and MRD-negative before enrollment.
• ECOG performance status \<3 and Karnofsky score ≥70.
• No history of grade III/IV graft-versus-host disease (GVHD) and no active GVHD at enrollment.
• Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO).
• Expected survival \>3 months.
• Voluntary provision of written informed consent, with ability to understand and comply with study requirements.

You may not qualify if:

• History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
• Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
• Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) \<60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men \>450 ms; women \>470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
• Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
• Severe hepatic impairment:ALT or total bilirubin (TBIL) \>3× upper limit of normal (ULN).
• Severe renal impairment:Serum creatinine (Cr) \>2× ULN.24-hour creatinine clearance (Ccr) \<50 mL/min.
• Active infection or uncontrolled bleeding, as assessed by the investigator to preclude safe administration of the study drug.
• History of thrombosis, embolism, cerebral hemorrhage, or other significant vascular events within the past year.
• Psychiatric disorders or other conditions that impair the ability to provide informed consent or comply with study procedures.
• Major organ surgery within the past six weeks.
• Drug abuse or chronic alcoholism that may interfere with study assessments.
• Prior organ transplantation (excluding hematopoietic stem cell transplantation).
• Other conditions deemed by the investigator to make the patient unsuitable for participation.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Leukemia; Recurrence

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Yi Luo, MD

CONTACT

86-13666609126; luoyijr@zju.edu.com

Luxin Yang, MD

CONTACT

86-13588756650; yangluxin2016@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 6, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)