Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548958
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Single-Arm Prospective Study of TBIBUMEL as Conditioning for SCT2 in Patients With Malignant Hematologic Diseases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Prospective Clinical Study of Total Body Irradiation Combined With Busulfan and Melphalan TBIBUMEL as a Conditioning Regimen for Second Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Each year over 20000 patients in China undergo hematopoietic stem cell transplantation HSCT Unfortunately the prognosis in patients with disease relapse or graft failure was inferior A second allogeneic hematopoietic stem cell transplantation SCT2 has emerged as a vital salvage therapy option Despite varying prognoses most patients undergoing SCT2 have a five-year overall survival OS rate of less than 30 The primary challenges of SCT2 include treatment strategy immune regulation complication management and transplantation technique improvements By optimizing these key aspects SCT2 can effectively address issues that arose after the first transplant reduce complications and provide more effective treatment for patients
Clinical practice indicates that SCT2 is crucial in treating various hematologic diseases For patients who failed the first transplant SCT1 SCT2 can more effectively treat the primary disease provide timely hematopoietic engraftment extend survival time and improve the quality of life Additionally the successful application of SCT2 provides clinicians with more treatment options and hope Currently the modified BUCY conditioning regimen which consists of busulfan BU and cyclophosphamide CY is commonly used in SCT1 in China However for patients who relapse after SCT1 these drugs may become ineffective and their physical condition often worsens with more probability of infections and organ dysfunction Therefore finding new conditioning regimens is crucial
Studies have shown that a melphalan MEL-based conditioning regimen may have better outcomes for patients with acute myeloid leukemia AML compared to a Cy-based regimen The Conditioning regimen that includes total body irradiation TBI has also been considered effective for patients with acute leukemia Thus low-dose TBI combined with a BU MEL regimen could be a promising conditioning regimen for SCT2 In our preliminary studies three patients who underwent SCT2 with this regimen successfully achieved engraftment and were discharged
Based on this we plan to conduct a clinical study to observe the effects of the TBIBUMEL regimen combined with SCT2 on the engraftment rate disease relapse rate GVHD incidence and survival rate in patients with malignant hematologic diseases who relapsed after SCT1
Clinical practice indicates that SCT2 is crucial in treating various hematologic diseases For patients who failed the first transplant SCT1 SCT2 can more effectively treat the primary disease provide timely hematopoietic engraftment extend survival time and improve the quality of life Additionally the successful application of SCT2 provides clinicians with more treatment options and hope Currently the modified BUCY conditioning regimen which consists of busulfan BU and cyclophosphamide CY is commonly used in SCT1 in China However for patients who relapse after SCT1 these drugs may become ineffective and their physical condition often worsens with more probability of infections and organ dysfunction Therefore finding new conditioning regimens is crucial
Studies have shown that a melphalan MEL-based conditioning regimen may have better outcomes for patients with acute myeloid leukemia AML compared to a Cy-based regimen The Conditioning regimen that includes total body irradiation TBI has also been considered effective for patients with acute leukemia Thus low-dose TBI combined with a BU MEL regimen could be a promising conditioning regimen for SCT2 In our preliminary studies three patients who underwent SCT2 with this regimen successfully achieved engraftment and were discharged
Based on this we plan to conduct a clinical study to observe the effects of the TBIBUMEL regimen combined with SCT2 on the engraftment rate disease relapse rate GVHD incidence and survival rate in patients with malignant hematologic diseases who relapsed after SCT1
Detailed Description:
The primary challenges of SCT2 include
1 treatment strategy eliminating residual tumor cells and addressing graft failure
2 immune regulation adjusting the immune system to ensure successful engraftment of new stem cells
3 complication management due to the poor physical condition of patients after the first transplant SCT1 the risk of complications after SCT2 is high This necessitates special attention to the prevention and management of post-transplant complications
4 transplantation technique improvements more rigorous donor screening HLA typing monitoring and supportive treatment during the transplant procedure
1 treatment strategy eliminating residual tumor cells and addressing graft failure
2 immune regulation adjusting the immune system to ensure successful engraftment of new stem cells
3 complication management due to the poor physical condition of patients after the first transplant SCT1 the risk of complications after SCT2 is high This necessitates special attention to the prevention and management of post-transplant complications
4 transplantation technique improvements more rigorous donor screening HLA typing monitoring and supportive treatment during the transplant procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None