NCT06461091

Brief Summary

Observation of event-free survival, engraftment rate, overall survival (OS), and safety data in patients aged ≥16 years with acute lymphoblastic leukemia (ALL) receiving a conditioning regimen including total marrow irradiation (TMI) followed by allogeneic hematopoietic stem cell transplantation. Aim to further enhance transplant outcomes in ALL patients based on the existing basis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

May 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 11, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

May 13, 2024

Last Update Submit

July 10, 2024

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).

    Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).

    1YEAR

Secondary Outcomes (2)

  • (1) Rate of granulocyte and platelet hematopoietic recovery.

    1YEAR

  • (2) Incidence of toxicity related to the conditioning regimen.

    1YEAR

Interventions

TMIRADIATION

Observing the efficacy and safety of allogeneic hematopoietic stem cell transplantation in treating adult acute lymphoblastic leukemia with a conditioning regimen including total marrow irradiation (TMI) in individuals aged 16 years and older: Primary Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients（ aged ≥16 years） with acute lymphoblastic leukemia (ALL) paining to receive allogeneic hematopoietic stem cell transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

erlie jiang

CONTACT

+86-15122538106jiangerlie@ihcams.ac.cn

yigeng cao

CONTACT

+86-18622477066caoyigeng@ams.ac.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

June 14, 2024

Study Start

July 1, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

July 11, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share