Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02295722
Status:
TERMINATED
Last Update Posted:
2024-07-08
First Post:
2014-10-30
Brief Title:
GEMHDM2014 Gem-HDM HDT and ASCT for Relapsed Refractory Lymphoma
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
Infusional Gemcitabine and High-dose Melphalan HDM Conditioning Prior to ASCT Autologous Stem Cell Transplantation for Patients With RelapsedRefractory Lymphoma
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It did not show a significant benefit to justify completing the full target accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMHDM2014
Brief Summary:
Objective of study To evaluate the safety and efficacy of infusional gemcitabine prior to HDM high-dose melphalan as HDCT High Dose Chemotherapy followed by autologous stem cell transplantation in patients with relapsedrefractory lymphoma
Detailed Description:
High-dose chemotherapy with autologous stem cell transplantation is the current standard of care for patients with chemosensitive relapsed Hodgkins lymphoma and aggressive non-Hodgkins lymphoma and is an established effective therapy for patients with relapsed follicular lymphoma Disease relapse remains a major problem occurring in 50 of these patients particularly in patients with primary refractory disease or other high-risk features The addition of gemcitabine to single-agent melphalan as a high-dose conditioning regimen presents a promising combination that may lead to improvements in EFS Event free survival If this trial gives encouraging results it may lead to a phase III trial evaluating this treatment strategy
Drug exposure would be AUC area under curve and clinical factors would be things like obesity renal function disease characteristics
We would be looking at the safety outcomes - ie adverse events as a measure of safety and tolerability The adverse events would be non-hematological toxicities any and whether or not it is related to AUC AUC in relationship to PFS progression free survival is also important we want to know if we need to adjust dose to improve PFS
Drug exposure would be AUC area under curve and clinical factors would be things like obesity renal function disease characteristics
We would be looking at the safety outcomes - ie adverse events as a measure of safety and tolerability The adverse events would be non-hematological toxicities any and whether or not it is related to AUC AUC in relationship to PFS progression free survival is also important we want to know if we need to adjust dose to improve PFS
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