the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia

A Prospective, Single-arm, Exploratory Clinical Study of the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06461091

Acronym

TMI

Enrollment

Registered

2024-06-14

Start date

2024-07-31

Completion date

2025-04-30

Last updated

2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Brief summary

Detailed description

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.Exploratory Endpoint: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).Secondary Exploratory Endpoints: (1) Rate of granulocyte and platelet hematopoietic recovery. (2) Incidence of toxicity related to the conditioning regimen.

Interventions

RADIATIONTMI

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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects eligible for inclusion in this study must meet all of the following criteria: (1) Definitive diagnosis of acute lymphoblastic leukemia requiring allogeneic hematopoietic stem cell transplantation. (2) Age greater than or equal to 16 years.

Exclusion criteria

* Subjects meeting any of the following criteria are not eligible for inclusion in this study: (1) Patients with extramedullary infiltration (excluding central nervous system leukemia). (2) Patients undergoing second transplantation. (3) Patients with concurrent malignancies. (4) Patients with malignancies secondary to a second tumor. (5) Patients assessed by the investigator to have accompanying diseases that are deemed to pose a serious risk to the patient's life or interfere with the patient's completion of this study.

Design outcomes

Primary

Measure	Time frame	Description
Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).	1YEAR	Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).

Secondary

Measure	Time frame	Description
(1) Rate of granulocyte and platelet hematopoietic recovery.	1YEAR	(1) Rate of granulocyte and platelet hematopoietic recovery.
(2) Incidence of toxicity related to the conditioning regimen.	1YEAR	(2) Incidence of toxicity related to the conditioning regimen.

Contacts

Primary Contacterlie jiang

jiangerlie@ihcams.ac.cn+86-15122538106

Backup Contactyigeng cao

caoyigeng@ams.ac.cn+86-18622477066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026