Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054776
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-09-20
Brief Title:
Acalabrutinib Obinutuzumab and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase 2 Study of Glofitamab With Acalabrutinib in Patients With RelapsedRefractory Mantle Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-10
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 phase II trial studies the side effects of acalabrutinib obinutuzumab and glofitamab and how well they work together for treating patients with mantle cell lymphoma that has come back after a period of improvement relapsed or that has not responded to previous treatment refractory Acalabrutinib is in a class of medications called kinase inhibitors It blocks a protein called BTK which is present on B-cell a type of white blood cells cancers such as mantel cell lymphoma at abnormal levels This may help keep cancer cells from growing and spreading A monoclonal antibody is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens Immunotherapy with monoclonal antibodies such as obinutuzumab may help the bodys immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread Glofitamab is a class of medications called bispecific antibodies Bispecific antibodies are designed to simultaneously bind to T cells and cancer cell antigens leading to T-cell activation proliferation and cancer cell death Giving acalabrutinib obinutuzumab and glofitamab together may be a safe and effective treatment for patients with relapsed or refractory mantle cell lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the safety and tolerability of a regimen combining acalabrutinib and glofitamab in patients with relapsedrefractory RR mantle cell lymphoma MCL Safety Lead-In II Estimate the complete response CR rate in RR MCL patients treated with acalabrutinib plus glofitamab Phase 2
SECONDARY OBJECTIVES
I Estimate the minimal residual disease MRD negativity rate time to response duration of response DOR progression-free survival PFS overall survival OS and patient-reported quality of life measures HRQOL in RR MCL patients treated with acalabrutinib plus glofitamab
II Evaluate the toxicity of acalabrutinib plus glofitamab for RR MCL
EXPLORATORY OBJECTIVES
I Examine the prognostic value of MRD assessment by next-generation sequencing NGS and circulating cell-free tumor deoxyribonucleic acid DNA ctDNA assessment in patients with RR MCL treated with acalabrutinib combined with glofitamab
II Examine the immune reconstitution T-cell fitness and immunomodulatory effects in patients with RR MCL treated with acalabrutinib combined with glofitamab
III Examine the evolution of tumor genetic profile and microenvironment in patients with RR MCL treated with acalabrutinib combined with glofitamab
OUTLINE
Patients receive acalabrutinib orally PO twice daily BID of each cycle obinutuzumab intravenously IV on days 1 and 7 of cycle 1 only and glofitamab IV over 2-4 hours on days 8 and 15 of cycle 1 and day 1 of subsequent cycles Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients with MRD positive complete response CR partial response PR or stable disease SD after 12 cycles of protocol therapy may continue receiving single agent acalabrutinib per standard of care during the follow-up phase of the study Patients also undergo a echocardiography ECHO or multigated acquisition scan MUGA during screening as well as positron emission tomography PETcomputed tomography CT or CT and blood specimen collection throughout the trial Patients may also undergo bone marrow biopsies throughout the trial
Upon completion of study treatment patients are followed up at 30 days and then every 3 months for response and bi-annually for survival for up to 4 years from start of treatment
I Evaluate the safety and tolerability of a regimen combining acalabrutinib and glofitamab in patients with relapsedrefractory RR mantle cell lymphoma MCL Safety Lead-In II Estimate the complete response CR rate in RR MCL patients treated with acalabrutinib plus glofitamab Phase 2
SECONDARY OBJECTIVES
I Estimate the minimal residual disease MRD negativity rate time to response duration of response DOR progression-free survival PFS overall survival OS and patient-reported quality of life measures HRQOL in RR MCL patients treated with acalabrutinib plus glofitamab
II Evaluate the toxicity of acalabrutinib plus glofitamab for RR MCL
EXPLORATORY OBJECTIVES
I Examine the prognostic value of MRD assessment by next-generation sequencing NGS and circulating cell-free tumor deoxyribonucleic acid DNA ctDNA assessment in patients with RR MCL treated with acalabrutinib combined with glofitamab
II Examine the immune reconstitution T-cell fitness and immunomodulatory effects in patients with RR MCL treated with acalabrutinib combined with glofitamab
III Examine the evolution of tumor genetic profile and microenvironment in patients with RR MCL treated with acalabrutinib combined with glofitamab
OUTLINE
Patients receive acalabrutinib orally PO twice daily BID of each cycle obinutuzumab intravenously IV on days 1 and 7 of cycle 1 only and glofitamab IV over 2-4 hours on days 8 and 15 of cycle 1 and day 1 of subsequent cycles Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients with MRD positive complete response CR partial response PR or stable disease SD after 12 cycles of protocol therapy may continue receiving single agent acalabrutinib per standard of care during the follow-up phase of the study Patients also undergo a echocardiography ECHO or multigated acquisition scan MUGA during screening as well as positron emission tomography PETcomputed tomography CT or CT and blood specimen collection throughout the trial Patients may also undergo bone marrow biopsies throughout the trial
Upon completion of study treatment patients are followed up at 30 days and then every 3 months for response and bi-annually for survival for up to 4 years from start of treatment
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 |
|---|---|---|---|
| NCI-2023-06838 | REGISTRY | None | None |
| 22402 | OTHER | None | None |
| P30CA033572 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchP30CA033572 |