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Not yet recruitingNCT06461091TMIUpdated Jul 11, 2024

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

An observational study in Acute Lymphoblastic Leukemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
16 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

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).

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What researchers measure

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).

    Time frame: 1YEAR

Secondary outcomes

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

    (1) Rate of granulocyte and platelet hematopoietic recovery.

    Time frame: 1YEAR

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

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

    Time frame: 1YEAR

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06461091
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Jul 2024 (estimated)
Primary completion
Apr 30, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Jul 11, 2024

Study contacts

erlie jiang
Contact
jiangerlie@ihcams.ac.cn
+86-15122538106
yigeng cao
Contact
caoyigeng@ams.ac.cn
+86-18622477066

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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