Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
594
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
Oral administration or IV infusion
Oral administration or IV infusion
IV infusion
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Infirmary Cancer Care ( Site 0157)
Mobile, Alabama, United States
RECRUITINGIronwood Cancer & Research Centers ( Site 0204)
Chandler, Arizona, United States
RECRUITINGPalo Verde Cancer Specialists ( Site 0105)
Glendale, Arizona, United States
RECRUITINGCity of Hope - Phoenix ( Site 0202)
Goodyear, Arizona, United States
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.
Time frame: Up to approximately 31 months
Progression-free Survival (PFS) per Lugano Response Criteria
PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by BICR or death due to any cause, whichever occurs first.
Time frame: Up to approximately 51 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 87 months
Event-free Survival (EFS) per Lugano Response Criteria
EFS is defined as the time from randomization to any of the following events: progressive disease per Lugano response criteria by BICR, death due to any cause, initiation of a new anti-caner therapy, or a positive biopsy for residual disease. The EFS for all participants will be presented.
Time frame: Up to approximately 51 months
Duration of CR
For participants who demonstrate CR at EOT per Lugano response criteria by BICR, duration of complete response is defined as the time from the first documented evidence of CR at or before EOT until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 51 months
Number of participants who experience one or more adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Time frame: Up to approximately 9 months
Number of participants who discontinue study intervention due to an AE
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
Time frame: Up to approximately 6 months
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI)
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
Time frame: Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Total Score
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
Time frame: Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7)
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.
Time frame: Baseline and up to Week 25
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
The FACT/GOG-NTX provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It is an 11-item questionnaire designed to measure the neurotoxicity subscale. The scoring of FACT/GOG-NTX is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. To produce a Neurotoxicity Subscale score (range 0-44), the sum of the item scores are multiplied by the number of items in the subscale, then divided by the number of items answered.
Time frame: Baseline and up to Week 25
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Genesis Cancer and Blood Institute ( Site 0193)
Hot Springs, Arkansas, United States
RECRUITINGRoy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
Burbank, California, United States
RECRUITINGCity of Hope Comprehensive Cancer Center ( Site 0191)
Duarte, California, United States
RECRUITINGBass Medical Group ( Site 0123)
Walnut Creek, California, United States
RECRUITINGRocky Mountain Cancer Centers (RMCC) ( Site 8001)
Aurora, Colorado, United States
RECRUITINGColorado West Healthcare System-Grand Valley Oncology ( Site 0165)
Grand Junction, Colorado, United States
RECRUITING...and 136 more locations