Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04479267
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2020-07-16
Brief Title:
Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Cyclophosphamide Doxorubicin and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma Double Expressor Lymphoma and High-Grade B Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-03
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 how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double triple hit lymphoma Double Expressor Lymphoma or High-Grade B Cell Lymphoma Polatuzumab vedotin is a monoclonal antibody that works by binding with cancer cells and releasing another chemotherapy drug called monomethyl auristatin E into the cell causing the cancer cells to die or stop growing Chemotherapy drugs such as rituximab cyclophosphamide doxorubicin and prednisone 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 Giving polatuzumab vedotin with combination chemotherapy may work better in treating patients with double or triple hit lymphoma compared to combination chemotherapy alone
Detailed Description:
PRIMARY OBJECTIVE
I To determine the rate of complete remission CR with polatuzumab vedotin plus rituximab cyclophosphamide doxorubicin hydrochloride and prednisone R-CHP in patients with newly diagnosed previously untreated double triple hit lymphoma Double Expressor Lymphoma or High-Grade B Cell Lymphoma as measured by positron emission tomography PET-defined CR rate using the modified Lugano response criteria at the time of primary response assessment 6-8 weeks after cycle 6 day 1 or last dose of study medication
PRIMARY OBJECTIVE
I To determine the rate of complete remission CR with polatuzumab vedotin plus rituximab cyclophosphamide doxorubicin hydrochloride and prednisone R-CHP in patients with newly diagnosed previously untreated double triple hit lymphoma Double Expressor Lymphoma or High-Grade B Cell Lymphoma as measured by positron emission tomography PET-defined CR rate using the modified Lugano response criteria at the time of primary response assessment 6-8 weeks after cycle 6 day 1 or last dose of study medication
SECONDARY SAFETY OBJECTIVE
I To evaluate the safety and tolerability of the combination of polatuzumab vedotin PoV plus R-CHP as defined by Common Terminology Criteria for Adverse Events CTCAE 50
SECONDARY EFFICACY OBJECTIVES
I To assess the progression free survival PFS with PoV plus R-CHP in the above-mentioned patient population
II To assess the overall survival OS with PoV plus R-CHP in the above-mentioned patient population
III To assess the overall response rate ORR complete response CR or partial response PR at the time of primary response assessment based on modified Lugano PET-computed tomography CT criteria as determined by the investigator
IV To assess the duration of response DOR to PoV plus R-CHP based on PET-CT as determined by the investigators in the above-mentioned patient population
EXPLORATORY OBJECTIVES
I To explore the relationship between CD79b expression and response to treatment with PoV plus R-CHP
II To explore the relationship between MYC expression and response to treatment with PoV plus R-CHP
III To explore polatuzumab vedotin treatment on Myc protein expression
OUTLINE
Patients receive prednisone orally PO prednisolone intravenously IV or methylprednisolone IV on days 1-5 Patients also receive rituximab IV polatuzumab vedotin IV over 30-90 minutes cyclophosphamide IV and doxorubicin hydrochloride IV on day 1 Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 12 months
I To determine the rate of complete remission CR with polatuzumab vedotin plus rituximab cyclophosphamide doxorubicin hydrochloride and prednisone R-CHP in patients with newly diagnosed previously untreated double triple hit lymphoma Double Expressor Lymphoma or High-Grade B Cell Lymphoma as measured by positron emission tomography PET-defined CR rate using the modified Lugano response criteria at the time of primary response assessment 6-8 weeks after cycle 6 day 1 or last dose of study medication
PRIMARY OBJECTIVE
I To determine the rate of complete remission CR with polatuzumab vedotin plus rituximab cyclophosphamide doxorubicin hydrochloride and prednisone R-CHP in patients with newly diagnosed previously untreated double triple hit lymphoma Double Expressor Lymphoma or High-Grade B Cell Lymphoma as measured by positron emission tomography PET-defined CR rate using the modified Lugano response criteria at the time of primary response assessment 6-8 weeks after cycle 6 day 1 or last dose of study medication
SECONDARY SAFETY OBJECTIVE
I To evaluate the safety and tolerability of the combination of polatuzumab vedotin PoV plus R-CHP as defined by Common Terminology Criteria for Adverse Events CTCAE 50
SECONDARY EFFICACY OBJECTIVES
I To assess the progression free survival PFS with PoV plus R-CHP in the above-mentioned patient population
II To assess the overall survival OS with PoV plus R-CHP in the above-mentioned patient population
III To assess the overall response rate ORR complete response CR or partial response PR at the time of primary response assessment based on modified Lugano PET-computed tomography CT criteria as determined by the investigator
IV To assess the duration of response DOR to PoV plus R-CHP based on PET-CT as determined by the investigators in the above-mentioned patient population
EXPLORATORY OBJECTIVES
I To explore the relationship between CD79b expression and response to treatment with PoV plus R-CHP
II To explore the relationship between MYC expression and response to treatment with PoV plus R-CHP
III To explore polatuzumab vedotin treatment on Myc protein expression
OUTLINE
Patients receive prednisone orally PO prednisolone intravenously IV or methylprednisolone IV on days 1-5 Patients also receive rituximab IV polatuzumab vedotin IV over 30-90 minutes cyclophosphamide IV and doxorubicin hydrochloride IV on day 1 Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 12 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | httpsreporternihgovquickSearchP30CA022453 |