Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799275
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2021-03-13
Brief Title:
Testing CC-486 Oral Azacitidine Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIIII Randomized Study of R-MiniCHOP With or Without CC-486 Oral Azacitidine in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma Grade IIIB Follicular Lymphoma Transformed Lymphoma and High-Grade B-Cell Lymphomas With MYC AND BCL2 andor BCL6 Rearrangements
Status:
RECRUITING
Status Verified Date:
2024-08
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 IIIII trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy reduced dose rituximab-cyclophosphamide doxorubicin vincristine and prednisone R-miniCHOP versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma R-miniCHOP includes a monoclonal antibody a type of protein called rituximab which attaches to the lymphoma cells and may help the immune system kill these cells R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs cyclophosphamide doxorubicin and vincristine These 3 chemotherapy drugs as well as oral azacitidine work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patients survival when compared to R-miniCHOP alone
Detailed Description:
PRIMARY OBJECTIVES
I To determine if the addition of CC-486 oral azacitidine to R-miniCHOP results in excess toxicity compared to R-miniCHOP alone that would preclude the combination from being studied further Safety run-in II To determine if the CC-486 R-miniCHOP regimen should be tested further Phase III against the control R-miniCHOP alone based on progression-free survival PFS Phase II component III To compare the overall survival OS between CC-486 R-miniCHOP and R-miniCHOP alone Phase III component
SECONDARY OBJECTIVES
I To assess the feasibility of delivering at least 4 cycles of CC-486 with R-miniCHOP in this population
II To assess toxicity for CC-486 R-miniCHOP and for R-miniCHOP III To compare complete response rates as defined by Lugano 2014 classification between CC-486 R-miniCHOP and R-miniCHOP alone
INTEGRATED CORRELATIVE GERIATRIC ASSESSMENTS
I To compare functioning as assessed by the S1918 Comprehensive Geriatric Assessment S1918 CGA between participants treated with CC-486 R-miniCHOP versus R-miniCHOP alone
II To evaluate if frailty status fitunfit versus vs frailsuperfrail as assessed by the FIL tool is associated with OS
III To evaluate if frailty as measured by the FIL tool correlates with the summary frailty index as measured using components of the S1918 CGA
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE
Beginning 7 days prior to starting protocol treatment all patients receive vincristine sulfate intravenously IV on day 1 and prednisone orally PO daily on days 1-7
Patients are then randomized to 1 of 2 arms
ARM I Patients receive CC-486 PO for 7 days prior to cycle 1 Patients then receive CC-486 PO on days 8-21 Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity Patients also receive rituximab IV or subcutaneously SC for cycles 2-6 cyclophosphamide IV doxorubicin hydrochloride IV and vincristine sulfate IV on day 1 and prednisone PO on days 1-5 Treatment repeats every 21 days for cycles 1-6 6 cycles total in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study
ARM II Patients receive rituximab IV or SC for cycles 2-6 cyclophosphamide IV doxorubicin hydrochloride IV and vincristine sulfate IV on day 1 and prednisone PO on days 1-5 Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study
After completion of study treatment patients are followed up periodically until 5 years from the date of registration
I To determine if the addition of CC-486 oral azacitidine to R-miniCHOP results in excess toxicity compared to R-miniCHOP alone that would preclude the combination from being studied further Safety run-in II To determine if the CC-486 R-miniCHOP regimen should be tested further Phase III against the control R-miniCHOP alone based on progression-free survival PFS Phase II component III To compare the overall survival OS between CC-486 R-miniCHOP and R-miniCHOP alone Phase III component
SECONDARY OBJECTIVES
I To assess the feasibility of delivering at least 4 cycles of CC-486 with R-miniCHOP in this population
II To assess toxicity for CC-486 R-miniCHOP and for R-miniCHOP III To compare complete response rates as defined by Lugano 2014 classification between CC-486 R-miniCHOP and R-miniCHOP alone
INTEGRATED CORRELATIVE GERIATRIC ASSESSMENTS
I To compare functioning as assessed by the S1918 Comprehensive Geriatric Assessment S1918 CGA between participants treated with CC-486 R-miniCHOP versus R-miniCHOP alone
II To evaluate if frailty status fitunfit versus vs frailsuperfrail as assessed by the FIL tool is associated with OS
III To evaluate if frailty as measured by the FIL tool correlates with the summary frailty index as measured using components of the S1918 CGA
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE
Beginning 7 days prior to starting protocol treatment all patients receive vincristine sulfate intravenously IV on day 1 and prednisone orally PO daily on days 1-7
Patients are then randomized to 1 of 2 arms
ARM I Patients receive CC-486 PO for 7 days prior to cycle 1 Patients then receive CC-486 PO on days 8-21 Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity Patients also receive rituximab IV or subcutaneously SC for cycles 2-6 cyclophosphamide IV doxorubicin hydrochloride IV and vincristine sulfate IV on day 1 and prednisone PO on days 1-5 Treatment repeats every 21 days for cycles 1-6 6 cycles total in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study
ARM II Patients receive rituximab IV or SC for cycles 2-6 cyclophosphamide IV doxorubicin hydrochloride IV and vincristine sulfate IV on day 1 and prednisone PO on days 1-5 Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study
After completion of study treatment patients are followed up periodically until 5 years from the date of registration
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-2020-01256 | REGISTRY | None | None |
| S1918 | OTHER | None | None |
| S1918 | OTHER | None | None |
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |