Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625359
Status:
TERMINATED
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
High-dose Chemotherapy with Thiotepa Busulfan and Cyclophosphamide Followed by Autologous Stem Cell Transplantation in Central Nervous System Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of High-dose Chemotherapy with Thiotepa Busulfan and Cyclophosphamide Before Autologous Stem Cell Transplantation in Patients with Primarysecondary Central Nervous System Lymphoma
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow enrollment
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The involvement of the central nervous system CNS by non-Hodgkin lymphoma NHL has carried a poor prognosis For both of primary central nervous system lymphoma PCNSL and secondary central nervous system lymphoma SCNSL high-dose methotrexate HD- MTX based chemotherapy and combined modality have significantly improved the previously poor response rates and prognosis However in PCNSL relapse rates have remained high with only 20 to 30 patients achieving a durable long-term remission after HD-MTX The combination with whole-brain radiotherapy WBRT has resulted in higher disease-free and overall survival rates but it has also been associated with severe neurotoxicity Patients with SCNSL fare the worst typically succumbing to disease within median 25 to 4 months with 1-year survival rates of only 25
Because of these dismal outcomes intensification of the high-dose chemotherapy HDCwith autologous stem cell transplantation autoSCT has been explored for PCNSL and SCNSL as salvage treatment in patients with refractory or relapsed disease and as consolidation after primary chemotherapy replacing or preceding WBRT Thiotepa busulfan and cyclophosphamide TBC have significant penetration of blood-brain barrier as shown in several pharmacokinetic studies Thus combination of these 3 agents was proposed as one high-dose chemotherapy regimen to achieve therapeutic concentrations in the lymphoma tissue in chemotherapy sanctuaries like cerebrospinal fluid CSF meninges and eyes eyes Several studies have shown promising results and favorable long-term toxicity profiles with this combination However the relatively rarity of this tumor precludes rapid completion of large-scale phase III trial and therefore our reliance on the results of well-designed phase II trials is critical Therefore we evaluate the efficacy and toxicity of thiotepa bulsulfan and cyclophosphamide as a conditioning for autologous stem cell transplantation in patients with PCNSL and SCNSL
Because of these dismal outcomes intensification of the high-dose chemotherapy HDCwith autologous stem cell transplantation autoSCT has been explored for PCNSL and SCNSL as salvage treatment in patients with refractory or relapsed disease and as consolidation after primary chemotherapy replacing or preceding WBRT Thiotepa busulfan and cyclophosphamide TBC have significant penetration of blood-brain barrier as shown in several pharmacokinetic studies Thus combination of these 3 agents was proposed as one high-dose chemotherapy regimen to achieve therapeutic concentrations in the lymphoma tissue in chemotherapy sanctuaries like cerebrospinal fluid CSF meninges and eyes eyes Several studies have shown promising results and favorable long-term toxicity profiles with this combination However the relatively rarity of this tumor precludes rapid completion of large-scale phase III trial and therefore our reliance on the results of well-designed phase II trials is critical Therefore we evaluate the efficacy and toxicity of thiotepa bulsulfan and cyclophosphamide as a conditioning for autologous stem cell transplantation in patients with PCNSL and SCNSL
Detailed Description:
None
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