NCT06381817

Brief Summary

The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are: Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL. Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
23mo left

Started Apr 2024

Typical duration for phase_3

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 Progress53%
Apr 2024Mar 2028

Study Start

First participant enrolled

April 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

April 19, 2024

Last Update Submit

April 24, 2024

Conditions

Acute T Cell Lymphoblastic LeukemiaHaploidentical Hematopoietic Stem Cell TransplantationCord Blood

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    estimated progression-free survival at 2 year

    2 years after randomization

Secondary Outcomes (4)

  • Overall survival

    2 years after randomization

  • Cumulative incidence of relapse

    2 years after randomization

  • Non-relapse mortality

    2 years after randomization

  • Adverse events

    2 years after randomization

Study Arms (2)

Haplo-cord HCT

EXPERIMENTAL

Patients enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical hematopoietic cell transplantation

Biological: Haplo-cord HCT

Haplo-HCT

ACTIVE COMPARATOR

Patients enrolled in this arm will receive a typical haploidentical hematopoietic cell transplantation

Biological: Haplo-HCT

Interventions

Haplo-cord HCTBIOLOGICAL

Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit

Haplo-cord HCT
Haplo-HCTBIOLOGICAL

Hematopoietic cell transplantation will be performed with a haploidentical donor

Haplo-HCT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute T cell lymphoblastic leukemia
  • With available minimal residual disease parameters assessed by flow cytometry and/or quantitative polymerase chain reaction
  • Willing to undergo haploidentical hematopoietic cell transplantation and having a suitable haploidentical donor
  • With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  • Signing an informed consent form, having the ability to comply with study and follow-up procedures

You may not qualify if:

  • With other malignancies
  • Failing to acquire a suitable unrelated cord blood unit
  • With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy
  • With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation
  • With severe organ dysfunction
  • In pregnancy or lactation period
  • With any conditions not suitable for the trial (investigators' decision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Yang XU

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang XU

CONTACT

86+051267781850xuyang1020@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2024

First Posted

April 24, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations

CN(1)