Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440135
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-03-05
Brief Title:
Ziftomenib Maintenance Post Allo-HCT
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
An Open Label Phase I Study of Ziftomenib As Maintenance Therapy Following Allogeneic Hematopoietic Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2024-08
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 test the safety effects and recommended dose of an investigational drug ziftomenib in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation allo-HCT This study plans to learn more about ziftomenib which targets and inhibits negative interactions within cancer cells related to AML when given after allo-HCT to determine if it improves outcomes following allo-HCT
The name of the study drug involved in this study is
Ziftomenib
The name of the study drug involved in this study is
Ziftomenib
Detailed Description:
This is a prospective multi-center open-label phase I study of ziftomenib as maintenance therapy following allogeneic hematopoietic cell transplantation HCT This study is testing whether ziftomenib combined with the standard allo-HCT treatment is safe and effective in treating blood cancer This study will test if ziftomenib improves outcomes after allo-HCT
The study drug is given after the allo-HCT in combination with standard treatment and aftercare
This study consists of 2 parts
Part A Dose Escalation The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects not everyone who participates in this research study will receive the same dose of the study intervention The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated Once determined this highest dose will then be used in the dose expansion part of the study
Part B Expansion Cohort Participants will be treated at the respective dose as determined during Part ADose Escalation
Ziftomenib administered after allo-HCT may work to enhance graft-versus-leukemia effects selectively target residual leukemic cells or suppress leukemic stem cells among other mechanisms The US Food and DrugAdministration FDA has not currently approved ziftomenib as a treatment for any disease but it is being studied in Phase 12 interventional clinical trials for participants with relapsed or refractory acute myelogenous leukemia
The estimated length of the study is 2 years Participants will begin treatment 30 to 90 days after allo-HCT and treatment will continue for up to 12 months Then they will be followed for 12 to 24 months after study treatment ends
It is expected that about 22 people will take part in this research study
The study drug is given after the allo-HCT in combination with standard treatment and aftercare
This study consists of 2 parts
Part A Dose Escalation The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects not everyone who participates in this research study will receive the same dose of the study intervention The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated Once determined this highest dose will then be used in the dose expansion part of the study
Part B Expansion Cohort Participants will be treated at the respective dose as determined during Part ADose Escalation
Ziftomenib administered after allo-HCT may work to enhance graft-versus-leukemia effects selectively target residual leukemic cells or suppress leukemic stem cells among other mechanisms The US Food and DrugAdministration FDA has not currently approved ziftomenib as a treatment for any disease but it is being studied in Phase 12 interventional clinical trials for participants with relapsed or refractory acute myelogenous leukemia
The estimated length of the study is 2 years Participants will begin treatment 30 to 90 days after allo-HCT and treatment will continue for up to 12 months Then they will be followed for 12 to 24 months after study treatment ends
It is expected that about 22 people will take part in this research study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None