Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598969
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
TMLI Plus Chemotherapy in High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Study of TMLI Administered in Combination With a Myeloablative Regimen Cyclophosphamide Etoposide for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With High-risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
TMLI-MA
Brief Summary:
Single-arm single-center phase II trial to evaluate the antileukemic activity and safetytolerability of TMLIcyclophosphamide and etoposide conditioning regimen followed by allogeneic hematopoietic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute myeloid leukemia
Detailed Description:
The aim of this study is the evaluation of the antitumor activity of the conditioning regimen with TMLI cyclophosphamide and etoposide followed by allogeneic hematopoietic stem cell transplantation by means of the progression-free survival at 2 years after a safety-lead phase
The determination of the complete remission rate at day 30 post-transplant the estimation of overall survival the cumulative incidence of recurrenceprogression and non-relapse mortality at 100 days 1 year and 2 years the Minima Residual Disease monitoring at 30 90 180 270 days and 1 year 1 year and a half and 2 years post-transplant and the assessment early and late toxicitiescomplications by organ and severity as well as dosedose-volume toxicity characterization across organs including acutechronic graft-versus-host disease infection and long-term complications are included as secondary objectives
The determination of the complete remission rate at day 30 post-transplant the estimation of overall survival the cumulative incidence of recurrenceprogression and non-relapse mortality at 100 days 1 year and 2 years the Minima Residual Disease monitoring at 30 90 180 270 days and 1 year 1 year and a half and 2 years post-transplant and the assessment early and late toxicitiescomplications by organ and severity as well as dosedose-volume toxicity characterization across organs including acutechronic graft-versus-host disease infection and long-term complications are included as secondary objectives
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