Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03410875
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2018-01-19
Brief Title:
A Phase II Study of the BRAF Inhibitor Vemurafenib Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of the BRAF Inhibitor Vemurafenib Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
This is a multi-center open label single arm phase II trial of the oral BRAF inhibitor vemurafenib plus obinutuzumab in patients with previously untreated HCL A Simon mini-max two-stage design will be employed to assess the efficacy of the combination treatment of vemurafenib and obinutuzumab In the first stage of the protocol 9 patients will be treated If fewer than 6 CRs are seen among the first 9 patients the study will be closed for lack of efficacy If at least 7 patients respond to the treatment then an additional 19 patients will be accrued to the second stage for a total of 28 patients
Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily bid continuously in cycles of 4 weeks 28 days for a total of 4 cycles
Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks Obinutuzumab infusions will be administered at 1000mg per day on days 1 8 and 15 during the cycle 2 and 1000mg per day every 4 weeks during the cycle 3 and 4 of treatment After the completion of the treatment ie after 4 cycles a bone marrow aspirate and biopsy will be performed for assessment of response and evaluation of minimal residual disease MRD In case of certain defined toxicities dose reductions of vemurafenib by 50 480mg bid or interruptions of up to 15 days are permitted If additional dose reduction is required vemurafenib may be reduced to 240mg oral bid
Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily bid continuously in cycles of 4 weeks 28 days for a total of 4 cycles
Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks Obinutuzumab infusions will be administered at 1000mg per day on days 1 8 and 15 during the cycle 2 and 1000mg per day every 4 weeks during the cycle 3 and 4 of treatment After the completion of the treatment ie after 4 cycles a bone marrow aspirate and biopsy will be performed for assessment of response and evaluation of minimal residual disease MRD In case of certain defined toxicities dose reductions of vemurafenib by 50 480mg bid or interruptions of up to 15 days are permitted If additional dose reduction is required vemurafenib may be reduced to 240mg oral bid
Detailed Description:
None
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