Ignite Creation Date:
2024-05-05 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00660400
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2008-04-16
Brief Title:
Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Pilot Study Of Pre-Transplant 5-Azacitidine Vidaza In Patients With High-Risk Myelodysplastic Syndrome MDS Who Are Candidates For Allogeneic Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out if treating people who have high-risk myelodysplastic syndrome MDS with 5-Azacitidine Vidaza prior to their allogeneic hematopoietic cell transplant HCT is helpful in preventing their myelodysplastic syndrome from coming back
In previous research 5-Azacitidine appeared to help the bone marrow of a patient with MDS begin to function more normally This means bone marrow cells can grow and do their work the way they were meant to 5-Azacitidine is approved by the Food and Drug Administration FDA for the treatment of MDS The effect of 5-Azacitidine in patients receiving hematopoietic cell transplants have not been studied
In previous research 5-Azacitidine appeared to help the bone marrow of a patient with MDS begin to function more normally This means bone marrow cells can grow and do their work the way they were meant to 5-Azacitidine is approved by the Food and Drug Administration FDA for the treatment of MDS The effect of 5-Azacitidine in patients receiving hematopoietic cell transplants have not been studied
Detailed Description:
RESEARCH PLAN
This will be a single-center prospective trial
Patients with high risk MDS that are potentially eligible for HCT will be enrolled
A donor search will be initiated and 5-Azacitidine will be given per standard practice
5-Azacitidine dose is 75 mgM2day subcutaneously by standard practice generally this is 7 days per monthly cycle but alterations occur depending on clinical and laboratory parameters
Patients where a suitable donor is not found can continue with 5-Azacitidine per standard treatment These patients will be followed until progression of MDS to acute myelogenous leukemia AML or death for up to one year
If a suitable donor is obtained the patient will proceed to HCT The HCT conditioning regimen will be dictated by the Blood and Marrow Transplant BMT physician While waiting HCT additional cycles 5-Azacitidine may be given Pre-HCT conditioning regimen therapy will begin no more than 8 weeks and no less than 4 weeks after the last administration of 5-Azacitidine
As the number of cycles of 5-Azacitidine is not standardized and the retrospective review of our patients noted above indicated a benefit to ANY exposure to 5-Azacitidine the actual number of cycles of 5-Azacitidine delivered will not be specified In addition as high risk MDS patients have an average time to death of 04 years any delay to HCT once it is available is to be avoided
A bone marrow biopsy will be performed to reassess disease response to therapy after the last cycle of 5-Azacitidine before transplant or after the fourth cycle of 5-Azacitidine whichever comes first Note that both the biopsy and the timing of the biopsy is a standard evaluation procedure
Donor progenitor cell collection will be prescribed by the BMT Attending Physician
HCT
The patient will undergo HCT designated per attending BMT physician
Supportive care will be based on institutional guidelines Stem cell collections processing and laboratory studies
Stem cell collections processing and laboratory studies
Graft assessment processing and characterization will be done as per institutional guidelines
Chimerism testing will be obtained to document post-transplant engraftment per standard practice
This will be a single-center prospective trial
Patients with high risk MDS that are potentially eligible for HCT will be enrolled
A donor search will be initiated and 5-Azacitidine will be given per standard practice
5-Azacitidine dose is 75 mgM2day subcutaneously by standard practice generally this is 7 days per monthly cycle but alterations occur depending on clinical and laboratory parameters
Patients where a suitable donor is not found can continue with 5-Azacitidine per standard treatment These patients will be followed until progression of MDS to acute myelogenous leukemia AML or death for up to one year
If a suitable donor is obtained the patient will proceed to HCT The HCT conditioning regimen will be dictated by the Blood and Marrow Transplant BMT physician While waiting HCT additional cycles 5-Azacitidine may be given Pre-HCT conditioning regimen therapy will begin no more than 8 weeks and no less than 4 weeks after the last administration of 5-Azacitidine
As the number of cycles of 5-Azacitidine is not standardized and the retrospective review of our patients noted above indicated a benefit to ANY exposure to 5-Azacitidine the actual number of cycles of 5-Azacitidine delivered will not be specified In addition as high risk MDS patients have an average time to death of 04 years any delay to HCT once it is available is to be avoided
A bone marrow biopsy will be performed to reassess disease response to therapy after the last cycle of 5-Azacitidine before transplant or after the fourth cycle of 5-Azacitidine whichever comes first Note that both the biopsy and the timing of the biopsy is a standard evaluation procedure
Donor progenitor cell collection will be prescribed by the BMT Attending Physician
HCT
The patient will undergo HCT designated per attending BMT physician
Supportive care will be based on institutional guidelines Stem cell collections processing and laboratory studies
Stem cell collections processing and laboratory studies
Graft assessment processing and characterization will be done as per institutional guidelines
Chimerism testing will be obtained to document post-transplant engraftment per standard practice
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 106349 | OTHER | USF IRB | None |