NCT07677878

Brief Summary

This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
29mo left

Started Dec 2024

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Dec 2024Dec 2028

Study Start

First participant enrolled

December 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 16, 2026

Last Update Submit

June 28, 2026

Conditions

ALL (Acute B-Lymphoblastic Leukemia)

Keywords

high-risk B-cell ALLBlinatumomabdonor lymphocyte infusion

Outcome Measures

Primary Outcomes (1)

  • 1 year progression-free-survival

    the percentage of patients who remain alive and whose disease has not gotten relapse one full year after they started treatment.

    1 year

Secondary Outcomes (4)

  • 1 year aGVHD rate

    100 days after transplantation

  • 1 year cGVHD rate

    365 days after transplantation

  • Nonrelapse mortality (NRM)

    365 days after transplantation

  • Overall survival (OS)

    365 days after transplantation

Study Arms (1)

BLINA+DLI

EXPERIMENTAL

blinatumomab 9ug d1-7, 28ug d8-14, DLI ( CD3+cell 1×10\^5/kg)

Drug: Blinatumomab InjectionOther: Donor Lymphocyte Infusion (DLI)

Interventions

Blinatumomab InjectionDRUG

blinatumomab 9ug d1-7, 28ug d8-14

BLINA+DLI
Donor Lymphocyte Infusion (DLI)OTHER

CD3+cell 1×10\^5/kg

BLINA+DLI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures.
  • \) Age: \<70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:
  • \>CR1 status
  • Pre-transplant MRD+ status
  • Ph-like subtype
  • KMT2A rearrangement
  • Other high-risk cytogenetic/genetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders.
  • \) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.
  • \) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).

You may not qualify if:

  • \) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).
  • \) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD: Patients with active infection or active graft-versus-host disease (GVHD).
  • \) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.
  • \) Impaired consent/compliance: Patients unable to provide informed consent or comply with procedures due to psychiatric/neurological disorders.
  • \) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.
  • \) Organ dysfunction:
  • Liver: ALT or AST \> 2.5 × ULN; Total bilirubin \> 2 × ULN
  • Kidney: Serum creatinine \> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

blinatumomab

Central Study Contacts

Lu Wang

CONTACT

86-10-66937079wangludophine@163.com

Liping Dou, Dr.

CONTACT

lipingruirui@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

June 16, 2026

First Posted

July 1, 2026

Study Start

December 1, 2024

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)