Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547944
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Zanubrutinib Obinutuzumab and Lenalidomide in Newly Diagnosed Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b Clinical Study of Lenalidomide in Combination With Zanubrutinib and Obinutuzumab ZGR in the Treatment of Newly Diagnosed Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL With Therapeutic Indications
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
ZGR in TN CLL
Brief Summary:
The ZGR regimen limited-course regimen was designed to combine three targeted agents zanubrutinib obinutuzumab a third-generation CD20 monoclonal antibody and lenalidomide to deepen the depth of remission in patients with new-diagnosis CLLSLL with a view to achieving the goal of discontinuation of the drug and long-term remission after discontinuation of the drug and prolonging the PFS and at the same time the regimen no longer includes cytotoxic chemotherapeutic agents such as fludarabine and cyclophosphamide which improves the CLL SLL patients treatment tolerance and can eliminate the treatment limitation for elderly or poorly tolerated CLLSLL patients
Detailed Description:
BTK inhibitor monotherapy for CLLSLL can obtain 80-90 ORR and give patients long-term survival but most patients only obtain PR efficacy even after up to 7-8 years of continuous treatment the proportion of patients with CR can only be improved from less than 10 to about 30 and it is very difficult for any patient to achieve MRD negativity so it is determined that the mode of treatment of BTK inhibitor monotherapy is long-term continuous administration for tumor control In order to change this pattern of long-term continuous treatment and to shorten the long-term continuous treatment to a limited cycle of treatment it is necessary to deepen the depth of remission by combining the treatment with other mechanisms of drugs or even to achieve MRD-negativity in order to realize the discontinuation of the drug
Lenalidomide is an oral immunomodulatory drug with direct antitumor effects and indirect antitumor effects by acting on a variety of immune cells in the tumor microenvironment Lenalidomide alone in combination with CD20 monoclonal antibody rituximab or and BTK inhibitors for the treatment of RR CLLSLL has shown therapeutic responses with the best response to triple therapy of lenalidomide in combination with rituximab and BTK inhibitors combination therapy showed the best response
The ZGR limited-course regimen that combines zanubrutinib obinutuzumab and lenalidomide in the treatment of patients with primary diagnosis of CLLSLL which can deepen the depth of remission with a view to achieving the goal of discontinuation of the drug and long-term remission after discontinuation of the drug and prolonging the PFS and at the same time the regimen are removed cytotoxic chemotherapeutic agents such as fludarabine to increase the tolerance of the treatment in patients with CLLSLL and can eliminate the need for treatment of elderly or poorly tolerated patients with CLLSLL treatment limitations in poorly tolerated CLLSLL patients
Lenalidomide is an oral immunomodulatory drug with direct antitumor effects and indirect antitumor effects by acting on a variety of immune cells in the tumor microenvironment Lenalidomide alone in combination with CD20 monoclonal antibody rituximab or and BTK inhibitors for the treatment of RR CLLSLL has shown therapeutic responses with the best response to triple therapy of lenalidomide in combination with rituximab and BTK inhibitors combination therapy showed the best response
The ZGR limited-course regimen that combines zanubrutinib obinutuzumab and lenalidomide in the treatment of patients with primary diagnosis of CLLSLL which can deepen the depth of remission with a view to achieving the goal of discontinuation of the drug and long-term remission after discontinuation of the drug and prolonging the PFS and at the same time the regimen are removed cytotoxic chemotherapeutic agents such as fludarabine to increase the tolerance of the treatment in patients with CLLSLL and can eliminate the need for treatment of elderly or poorly tolerated patients with CLLSLL treatment limitations in poorly tolerated CLLSLL patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None