Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT04479267
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
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) 5.0.
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) 5.0.
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA022453 | NIH | None | https://reporter.nih.gov/quic… | View |