About this trial
Application of Stereotactic Body Radiotherapy (SBRT) Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Adult Hematological Malignance Patients with Extramedullary Lesions. This study aims to improve transplantation outcomes with extramedullary lesions. The investigators aim to study the Post-Transplantation Evaluation of Disease-Free Survival, Overall Survival, Treatment-Related Mortality, Cumulative Recurrence Rate, Post-Transplantation Complications, and Safety Data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 60 years.
A confirmed diagnosis of a hematologic malignancy, including but not limited to Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Chronic Myeloid Leukemia (CML), Myelodysplastic Syndromes (MDS), Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma (HL), and Multiple Myeloma (MM).
Diagnosis of extramedullary disease/lesions confirmed by one of the following: pathological biopsy, cytology, or at least one imaging modality (including PET-CT, contrast-enhanced CT, or contrast-enhanced MRI).
Presence of a suitable donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Disqualifiers
Previous history of one or more autologous or allogeneic stem cell transplants prior to enrollment.
Uncontrolled infection at the time of enrollment, or requirement for mechanical ventilatory assistance, or hemodynamic instability.
Severe organ dysfunction, including but not limited to hepatic or renal impairment, and heart failure.
Evidence of active HIV replication; positive HCV antibody and detectable HCV-RNA within 90 days prior to enrollment; or positive HBsAg. Known seropositivity for HIV or active hepatitis C virus.
Trial design
Single group
Treatments tested in this trial
Stereotactic body radiotherapy (SBRT)
RadiationStereotactic Body Radiotherapy (SBRT) before bridging to HSCT
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival
Secondary outcomes
relapse free survival
cumulative incidence of relapse
treatment related mortality
Extramedullary disease evaluation (RECIST v1.1)
Locations
Sponsors and contacts
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