Ignite Creation Date:
2024-05-06 @ 9:05 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02891603
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2016-09-01
Brief Title:
A Phase III GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase III GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression
Status:
COMPLETED
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 examine a new approach to preventing a serious problem after transplant called graft vs host disease abbreviated as GVHD
This is a 3 arm sequential phase III study of Pacritinib with Sirolimus and Tacrolimus PACSIRTAC for the prevention of acute GVHD after matched related and unrelated allogeneic hematopoietic cell transplantation alloHCT
This is a 3 arm sequential phase III study of Pacritinib with Sirolimus and Tacrolimus PACSIRTAC for the prevention of acute GVHD after matched related and unrelated allogeneic hematopoietic cell transplantation alloHCT
Detailed Description:
GVHD is a common problem that occurs after transplant despite the use of standard immune suppressive medications these are called sirolimus and tacrolimus GVHD can result in skin rash nausea vomiting diarrhea and liver damage Severe GVHD can be life-threatening
In this study investigators will add a medication called pacritinib to the combination of sirolimus and tacrolimus to see if this approach can more effectively prevent GVHD Pacritinib is a medicine used to treat a disease of the bone marrow called myelofibrosis Pacritinib turns off a switch in cells called Janus Kinase 2 JAK2 Pacritinib is an investigational medicine used in several clinical trials and not FDA approved JAK2 is an important regulator of inflammation This inflammation is thought to contribute to GVHD Pacritinib is able to turn this inflammation off by inhibiting JAK2 Research has shown that blocking JAK2 prevents GVHD in mice and also reduces severe GVHD in transplant patients Doctors at Moffitt have identified that inflammation from JAK2 is an important cause of GVHD and is present well before patients develop GVHD symptoms This trial will study how well pacritinib turns off inflammation during the transplant and if it prevents GVHD when added to our standard medicines
Pacritinib will begin the day of the participants transplant Day 0 and will continue until 70 days after the transplant
Sirolimus will be given the day before transplant and continued daily for at least one year
Tacrolimus will begin 3 days before transplant and will be given for at least 50 days
In this study investigators will add a medication called pacritinib to the combination of sirolimus and tacrolimus to see if this approach can more effectively prevent GVHD Pacritinib is a medicine used to treat a disease of the bone marrow called myelofibrosis Pacritinib turns off a switch in cells called Janus Kinase 2 JAK2 Pacritinib is an investigational medicine used in several clinical trials and not FDA approved JAK2 is an important regulator of inflammation This inflammation is thought to contribute to GVHD Pacritinib is able to turn this inflammation off by inhibiting JAK2 Research has shown that blocking JAK2 prevents GVHD in mice and also reduces severe GVHD in transplant patients Doctors at Moffitt have identified that inflammation from JAK2 is an important cause of GVHD and is present well before patients develop GVHD symptoms This trial will study how well pacritinib turns off inflammation during the transplant and if it prevents GVHD when added to our standard medicines
Pacritinib will begin the day of the participants transplant Day 0 and will continue until 70 days after the transplant
Sirolimus will be given the day before transplant and continued daily for at least one year
Tacrolimus will begin 3 days before transplant and will be given for at least 50 days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HL133823-02 | NIH | None | httpsreporternihgovquickSearch5R01HL133823-02 |