Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-07 @ 12:23 AM
Study NCT ID:
NCT03280160
Status:
UNKNOWN
Last Update Posted:
2022-09-16
First Post:
2017-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol GELLC-7: Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab
Sponsor:
PETHEMA Foundation
Organization:
Study Overview
Official Title:
A Multicenter, Non-randomized, Open Label Study to Evaluate the Efficacy and Security of Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Based on the promising results obtained with ibrutinib as single agent, the results obtained with ibrutinib in combination with ofatumumab in a previous phase I/IIb study (Jaglowski 2015), and since data from in vitro studies do not support a synergistic effect of the combination of ibrutinib and anti-CD20 mAbs, we propose a chemotherapy-free combined strategy based on ibrutinib monotherapy as front line treatment for patients with CLL, with the addition of a consolidation phase with ofatumumab in patients not attaining CR under ibrutinib in order to improve the quality of their response. Since median time to CR with ibrutinib was nearly 12 months, patients will be evaluated at this time point, and those patients not in CR will add consolidated treatment with Ofatumumab. Thus, this multi-center, non-randomized phase 2 study is designed to evaluate the efficacy and safety of ibrutinib alone or in combination with Ofatumumab in patients no attaining CR under ibrutinib as front-line therapy for patients with chronic lymphocytic leukemia.
Detailed Description:
Multicenter, non- randomized, open-label, double agent, phase II study of the Spanish Group of CLL (GELLC).
Patients with untreated CLL/SLL. Ibrutinib will be administered orally 420 mg (3 x 140 mg capsules) once daily on a continuous schedule on an outpatient basis until disease progression or unacceptable toxicity.
After 12 cycles of ibrutinib, patients that do not achieve a complete response (CR) will be treated with the combination of ibrutinib and ofatumumab. Patients in CR after 12 cycles of ibrutinib will continue with ibrutinib alone.
Ofatumumab will be administered by IV infusion, 300mg on Day 1 and 1,000 mg on Day 8 of cycle 13, followed by 5 monthly infusions of 1,000 mg (Day 1 of subsequent 28-day cycles for cycles C14, C15, C16, C17, and C18).
A treatment cycle will be defined as lasting 28 days. Patients will be treated with ibrutinib, within the study frame, until progression, unacceptable toxicity or cycle C42 of treatment).
All patients still on study treatment at the time of cycle C42, or if the study is stopped early, will be transitioned to prescribed ibrutinib.
Patients with untreated CLL/SLL. Ibrutinib will be administered orally 420 mg (3 x 140 mg capsules) once daily on a continuous schedule on an outpatient basis until disease progression or unacceptable toxicity.
After 12 cycles of ibrutinib, patients that do not achieve a complete response (CR) will be treated with the combination of ibrutinib and ofatumumab. Patients in CR after 12 cycles of ibrutinib will continue with ibrutinib alone.
Ofatumumab will be administered by IV infusion, 300mg on Day 1 and 1,000 mg on Day 8 of cycle 13, followed by 5 monthly infusions of 1,000 mg (Day 1 of subsequent 28-day cycles for cycles C14, C15, C16, C17, and C18).
A treatment cycle will be defined as lasting 28 days. Patients will be treated with ibrutinib, within the study frame, until progression, unacceptable toxicity or cycle C42 of treatment).
All patients still on study treatment at the time of cycle C42, or if the study is stopped early, will be transitioned to prescribed ibrutinib.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: