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

Institute of Hematology & Blood Diseases Hospital, China20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Lymphoblastic Leukemia

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

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1YEAR

Secondary Outcomes

(1) Rate of granulocyte and platelet hematopoietic recovery.

Time frame: 1YEAR

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

Time frame: 1YEAR

Central Contacts

erlie jiang

CONTACT

+86-15122538106 jiangerlie@ihcams.ac.cn

yigeng cao

CONTACT

+86-18622477066 caoyigeng@ams.ac.cn

Data from ClinicalTrials.gov

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