Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333262
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-20
Brief Title:
Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia
Sponsor:
Inhye Ahn
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 2 Study of Fixed Duration Therapy With Pirtobrutinib and Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia POP
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles approximately 1 year as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma CLL or SLL
Detailed Description:
This is an open-label multicenter single-arm phase 2 study of pirtobrutinib with obinutuzumab for participants with CLL or SLL Eligible participants will receive 6 cycles of pirtobrutinib alone followed by an additional 6 cycles of pirtobrutinib-obinutuzumab combination therapy All participants will stop treatment after 12 cycles in total approximately 1 year
If CLL progresses and requires treatment after 1-year of therapy participants will receive retreatment with pirtobrutinib only Participants will be followed for up to a total of 10 years Up to 60 participants will take part in this study
The US Food and Drug Administration FDA has approved pirtobrutinib for continuous treatment of CLL that has relapsed or become refractory to other treatments Pirtobrutinib is not approved for the first-line treatment of CLLSLL nor for fixed-duration therapy The FDA has approved obinutuzumab for the treatment of CLL
The research study procedures include screening for eligibility study treatment visits electrocardiograms imaging eg computerized tomography or CT scans blood tests saliva tests bone marrow biopsies andor lymph node biopsies if feasible
Loxo Oncology at Eli Lilly and Company is supporting this study by providing pirtobrutinib and research funding
If CLL progresses and requires treatment after 1-year of therapy participants will receive retreatment with pirtobrutinib only Participants will be followed for up to a total of 10 years Up to 60 participants will take part in this study
The US Food and Drug Administration FDA has approved pirtobrutinib for continuous treatment of CLL that has relapsed or become refractory to other treatments Pirtobrutinib is not approved for the first-line treatment of CLLSLL nor for fixed-duration therapy The FDA has approved obinutuzumab for the treatment of CLL
The research study procedures include screening for eligibility study treatment visits electrocardiograms imaging eg computerized tomography or CT scans blood tests saliva tests bone marrow biopsies andor lymph node biopsies if feasible
Loxo Oncology at Eli Lilly and Company is supporting this study by providing pirtobrutinib and research funding
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