Clinical trial NCT06461091: the Efficacy and Safety of Total Myeloid Irradiation (TMI) in the Treatment of Adult Acute Lymphoblastic Leukemia
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients（ aged ≥16 years） with acute lymphoblastic leukemia (ALL) paining to receive allogeneic hematopoietic stem cell transplantation.

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.

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.

Eligibility criteria: 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\&#39;s life or interfere with the patient\&#39;s completion of this study.

Primary outcomes:
measure: Event-free survival at 1 year post allogeneic hematopoietic stem cell transplantation (EFS).
timeFrame: 1YEAR
Secondary outcomes:
measure: (1) Rate of granulocyte and platelet hematopoietic recovery.
timeFrame: 1YEAR
measure: (2) Incidence of toxicity related to the conditioning regimen.
timeFrame: 1YEAR
Other outcomes:
Locations:
Study officials:
References: