Clinical Trial Radar

Name: CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial
Creator: Peking University People's Hospital
Published: 2026-02-27
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07441291 for B ALL, Allogenetic Hematopoietic Stem Cell Transplantation, MRD-positive is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT Phase 3 70 Randomized Crossover Design Open-Label Overall Survival

Recruiting

Clinical Trial NCT07441291 is designed to study Treatment for B ALL, Allogenetic Hematopoietic Stem Cell Transplantation, MRD-positive. It is a Phase 3 interventional study that is recruiting, having started on 30 November 2025, with plans to enroll 70 participants. Led by Peking University People's Hospital, it is expected to complete by 30 December 2028. The latest data from ClinicalTrials.gov was last updated on 27 February 2026.

Brief Summary

This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT).

Patients (aged 3-<80 years, ECOG 0-2, no relapse, ...

Detailed Description

Objective: This prospective, open-label, randomized controlled trial (RCT) aims to compare the efficacy and safety of CD19 chimeric antigen receptor T-cell (CAR-T) therapy versus chemotherapy plus donor lymphocyte infusion (DLI) in patients with Ph-negative acute B-lymphoblastic leukemia (Ph- B-ALL) positive for minimal residual disease (MRD) after allogeneic hematopoietic stem cell transplantation (HSCT).

Study Pop...

Official Title

CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial

Conditions

B ALLAllogenetic Hematopoietic Stem Cell TransplantationMRD-positive

Other Study IDs

CD19 CAR-T vs DLI for MRD

NCT ID Number

NCT07441291

Start Date (Actual)

2025-11-30

Last Update Posted

2026-02-27

Completion Date (Estimated)

2028-12-30

Enrollment (Estimated)

Study Type

Interventional

PHASE

Phase 3

Status

Recruiting

Keywords

CD19 CAR-T
Donor Lymphocyte Infusion (DLI)
Ph-negative B-ALL
Minimal Residual Disease (MRD)
Hematopoietic Stem Cell Transplantation (HSCT)

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalCAR-T group Autologous CD19 CAR-T (1.0×10⁶/kg, single IV infusion) after cyclophosphamide + fludarabine lymphodepletion (no bridging chemo).	CAR-T Autologous CD19 CAR-T cells (1.0×10⁶/kg, single intravenous infusion) following lymphodepletion with cyclophosphamide (300mg/m²/d ×3d) + fludarabine (30mg/m²/d ×3d); no bridging chemotherapy allowed.
Active ComparatorControl group Chemotherapy + DLI	DLI Chemotherapy combined with DLI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month MRD negativity rate	MRD negativity rate of MFC	3-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year MRD negativity rate	1-year MRD negativity rate of MFC	1-year
relapse rate	relapse rate of leukemia	1-year
OS	overall survival	1-year
DFS	Disease free survival	1-year
GVHD incidence	the rate and degree of aute and chronic graft versus host disease	1-year
GRFS	GVHD and relapse free survival	1-year
grade III-IV hematological toxicity duration	grade III-IV hematological toxicity duration	3 months

Participation Assistant

Eligibility Criteria

Eligible Ages

Child, Adult, Older Adult

Minimum Age

3 Years

Eligible Sexes

All

age 3-<80 years
ECOG performance status 0-2
post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)
no hematological/extramedullary relapse
adequate organ function
negative pregnancy test (for fertile females)

active infections
uncontrolled graft-versus-host disease (GVHD)
history of central nervous system disorders
autoimmune diseases
other active malignancies

Peking University People's Hospital

Study Responsible Party

Xiao-Jun Huang, Principal Investigator, Chief, Peking University People's Hospital

Study Central Contact

Contact: Jing Liu, Doctor, 8610-88326900, [email protected]

1 Study Locations in 1 Countries

China

Peking University People's Hospital, Beijing, China, 100044, China

Jing Liu, Contact, 8610-88326900, [email protected]

Recruiting

CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT Phase 3 70 Randomized Crossover Design Open-Label Overall Survival

Inclusion Criteria

Exclusion Criteria