Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602323
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
TMLIFludarabineMelphalan Conditioning for Allogeneic Transplantation in High-risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Study of Total Marrow and Lymphoid Irradiation TMLI Administered in Combination With a Reduced-intensity Regimen Based on Fludarabine and Melphalan as Conditioning for Allogeneic Hematopoietic Stem Cell Transplantation AHSCT 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-RI
Brief Summary:
The goal of this clinical trial is to learn if drugs fludarabine and melphalan combinated with a targeted irradiation in bone marrow and in lymphoid tissue works to treat blood cancers high risk myelodysplastic syndrome or acute myeloid leukemia in adults It will also learn about the safety of this combination of drugs and irradiation The main questions it aims to answer are
Does this combined therapy result in an improved survival and decreased relapseprogression rate after a bone marrow transplant
What toxicities or complications do participants have when taking this combined therapy
Researchers will use this combined therapy to see if it works to treat high risk myelodysplastic syndrome or acute myeloid leukemia through the evaluation of the length of time during the treatment and 2 years after the treatment that a patient lives with the disease but it does not get worse progression-free survival
Participants will
Receive the combined therapy study treatment one week before the bone marrow transplant
Receive too post-transplant medication as per usual clinical practice
Patients will have to attend medical visits checkups and tests for 2 years
Does this combined therapy result in an improved survival and decreased relapseprogression rate after a bone marrow transplant
What toxicities or complications do participants have when taking this combined therapy
Researchers will use this combined therapy to see if it works to treat high risk myelodysplastic syndrome or acute myeloid leukemia through the evaluation of the length of time during the treatment and 2 years after the treatment that a patient lives with the disease but it does not get worse progression-free survival
Participants will
Receive the combined therapy study treatment one week before the bone marrow transplant
Receive too post-transplant medication as per usual clinical practice
Patients will have to attend medical visits checkups and tests for 2 years
Detailed Description:
This is a single-arm single center phase II trial to evaluate the antileukemic activity and safety of the AHSCT TMLIFluMel conditioning regimen in patients with high-risk myelodysplastic syndrome or acute myeloid leukemia A patient safety-lead phase will be carried out to ensure there are no unexpected toxicities Ultimately a total of 34 patients will be treated at the TMLIFluMel dose level deemed safe as determined during the introductory patient safety segment of this study
Up to three dose levels can be studied A 33 de-escalation design comprising a patient safety-lead phase will be applied in successive patient cohorts to evaluate the safety of the TMLI schedule and identify the optimal treatment dose
Initially 3 patients will be treated at the starting TMLI dose Dose Level 1 1200 cGy If 0 or 1 DLT is observed among the first 6 patients at Dose Level 1 then 28 additional patients will be treated at this dose level allowing for the evaluation of 34 patients treated at the target dose level If 26 patients experience a DLT at Dose Level 1 then the MTD has been exceeded and the next lower TMLI dose Dose Level -1 1100 cGy will be expanded to up to 6 patients If 0 or 1 patient out of 6 experiences a DLT this dose level will be further evaluated n28 additional patients If 26 patients experience a DLT the next lower dose Dose Level -2 1000 cGy level will be expanded applying the same criteria No further dose level reductions will be allowed beyond Dose Level -2
No more than 3 patients may be ampamplt30 days after stem cell infusion at any time during patient safety introduction The tacrolimus dose and MMF dose will remain fixed for all defined dose levels and will not be reduced at any time
Considering this proposed design the expected sample size of the study will be n34 patients with a potential minimum and maximum size of n34 and n46 respectively
Up to three dose levels can be studied A 33 de-escalation design comprising a patient safety-lead phase will be applied in successive patient cohorts to evaluate the safety of the TMLI schedule and identify the optimal treatment dose
Initially 3 patients will be treated at the starting TMLI dose Dose Level 1 1200 cGy If 0 or 1 DLT is observed among the first 6 patients at Dose Level 1 then 28 additional patients will be treated at this dose level allowing for the evaluation of 34 patients treated at the target dose level If 26 patients experience a DLT at Dose Level 1 then the MTD has been exceeded and the next lower TMLI dose Dose Level -1 1100 cGy will be expanded to up to 6 patients If 0 or 1 patient out of 6 experiences a DLT this dose level will be further evaluated n28 additional patients If 26 patients experience a DLT the next lower dose Dose Level -2 1000 cGy level will be expanded applying the same criteria No further dose level reductions will be allowed beyond Dose Level -2
No more than 3 patients may be ampamplt30 days after stem cell infusion at any time during patient safety introduction The tacrolimus dose and MMF dose will remain fixed for all defined dose levels and will not be reduced at any time
Considering this proposed design the expected sample size of the study will be n34 patients with a potential minimum and maximum size of n34 and n46 respectively
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