The Efficacy and Safety of Stereotactic Radiotherapy Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Hematological Malignance Patients With Extramedullary Infiltrating

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Stereotactic body radiotherapy (SBRT)

    Radiation

    Stereotactic Body Radiotherapy (SBRT) before bridging to HSCT

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SBRT+HSCTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Time frame
one year

Secondary outcomes

1

relapse free survival

Time frame
one year
2

cumulative incidence of relapse

Time frame
one year
3

treatment related mortality

Time frame
one year
4

Extramedullary disease evaluation (RECIST v1.1)

Time frame
one year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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