Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03610971
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2018-07-19
Brief Title:
Treatment Free Remission After Combination Therapy with Ruxolitinib Plus Tyrosine Kinase Inhibitors
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Treatment Free Remission After Combination Therapy with Ruxolitinib Plus Tyrosine Kinase Inhibitors in Chronic Phase Chronic Myeloid Leukemia CP-CML Patients Who Relapsed After a Prior Attempt At TKI Discontinuation
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 determine if adding Ruxolitinib to a Tyrone Kinase Inhibitor TKI prior to a second attempt at stopping a TKI will lead to prolonged treatment free remission TFR
Detailed Description:
All participants will have a confirmed diagnosis of chronic phase chronic myeloid leukemia CML and must have previously attempted to discontinue TKI therapy All participants must be restarted on a TKI at the time of relapse in order to be eligible for this trial
After completion of 12 cycles of combination therapy eligible participants will remain in the TFR phase of the study for up to 36 months and will have central polymerase chain reaction PCR testing during the first 24 months Therefore the total duration of the trial will be approximately 48 months 12 months on combination treatment phase 36 months in the TFR phase
After completion of 12 cycles of combination therapy eligible participants will remain in the TFR phase of the study for up to 36 months and will have central polymerase chain reaction PCR testing during the first 24 months Therefore the total duration of the trial will be approximately 48 months 12 months on combination treatment phase 36 months in the TFR phase
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 |
|---|---|---|---|
| HJKC3-0002 | OTHER | H Jean Khoury Cure CML Consortium | None |