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Funding
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL).
This combination has not been approved by the Food and Drug Administration (FDA) for the treatment of rrDLBCL. Salvage therapy (treatment after standard treatment failed) needs to be improved. Rituximab, gemcitabine, dexamethasone, and cisplatin combination is a standard therapy for rrDLBCL and polatuzumab vedotin (PV) is a novel antibody-drug conjugate targeting CD79b. PV has shown efficacy in the setting of rrDLBCL and can improve the response rates of standard salvage therapy.
This study will focus on subjects in the first relapse (one prior regimen) and will include both subjects who are transplant eligible and those who are transplant ineligible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polatuzumab vedotin (PV) | Drug | 1.8 mg/kg, intravenous, at day 1, in every 21 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the number of subjects who received the study treatment, and achieved complete response (CR) or partial response (PR) by Lugano classification. Complete Response: Complete metabolic response on Positron emission tomography (PET) image or Target nodes/nodal masses must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease on Computerized Tomography (CT). Partial Response: Score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size on PET and ≥50% decrease in the sum of the products of diameters (SPD) of up to 6 target measurable nodes and extranodal sites on CT. | Up to 4 months (End of Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CR) | CR is defined as the number of subjects who received the study treatment, achieved complete response (CR) by the Lugano classification. | Up to 4 months (End of Treatment) |
| Progression Free Survival (PFS) |
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In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Dittus, DO, MPH | Division of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | United States |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Participants who signed consent, were deemed eligible, and began the study between 2/17/2023 and 1/07/2024 at a single center in North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | ORR is defined as the number of subjects who received the study treatment, and achieved complete response (CR) or partial response (PR) by Lugano classification. Complete Response: Complete metabolic response on Positron emission tomography (PET) image or Target nodes/nodal masses must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease on Computerized Tomography (CT). Partial Response: Score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size on PET and ≥50% decrease in the sum of the products of diameters (SPD) of up to 6 target measurable nodes and extranodal sites on CT. | Participants started the study treatment. | Posted | Count of Participants | Participants | Up to 4 months (End of Treatment) |
|
Up to 2 years (From day 1 of study treatment and continue through the 30-day follow-up period after treatment is discontinued).
All hospital admissions were categorized as serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
The study was terminated upon reaching its accrual goal; however, the number of enrolled subjects was insufficient to support the planned analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melahat Canter | UNC Lineberger | (919) 962-0000 | Melahat_Canter@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2023 | Jan 6, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000600736 | polatuzumab vedotin |
| D000069283 | Rituximab |
| D006821 | Hyaluronoglucosaminidase |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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The study will use a Simon two-stage design. In the first stage 27 evaluable subjects will be recruited. If there are at least 13 (≥ 13) subjects with a partial or complete response after 4 cycles, another 17 subjects will be enrolled and treated in the second stage of the trial, for a total of 44 evaluable subjects.
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| Rituximab |
| Drug |
375 mg/m2 intravenous, at day 1 or day 2, in every 21 days |
|
| Hyaluronidase | Drug | 1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days |
|
| Gemcitabine | Drug | 1,000 mg/m2 intravenous at day 1 and 8, in every 21 days |
|
| Cisplatin | Drug | 75 mg/m2, intravenous, at day 1, in every 21 days |
|
| Dexamethasone | Drug | 40 mg intravenous at day 1, Per oral days at days 2-4 |
|
| GCSF | Drug | granulocyte-colony stimulating factor (GCSF ) |
|
PFS is defined as the time from the start of study treatment until death, during which participants show no disease progression per Lugano criteria Progressive Disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new fluorodeoxyglucose (FDG) -avid foci consistent with lymphoma at the interim or end-of-treatment assessment on PET, or an individual node/lesion must be abnormal with LDi > 1.5 cm, increase by ≥ 50% from the cross product of the shortest axis perpendicular to LDi (SDi) nadir and an increase in LDi or SDi from nadir: 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions > 2 cm.
| Up to 2 years |
| Overall Survival (OS) | OS is the time from treatment start until death from any cause; participants still alive are censored. | Up to 2 years |
| Number of Participants With Adverse Events | The number of participants with adverse events will be listed and tabulated by grade to determine the safety and toxicity. Adverse Events will be graded according to The National Cancer Institute (NCI) of Common Terminology Criteria for Adverse Events (CTCAE) version 5. The scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Up to 2 years |
| Number of Participants With Serious Adverse Events | The number of participants with adverse events (AEs) will be tabulated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. AEs are reported with specific terms where possible (e.g., bacteremia, kidney infection, sepsis) under each Organ System Class to avoid repetition. Each AE term is graded as follows: Grade 1 (Mild; asymptomatic or mild symptoms, no intervention), Grade 2 (Moderate; minimal intervention, limits instrumental Activities of Daily Living), Grade 3 (Severe; hospitalization or disabling, limits self-care Activities of Daily Living), and Grade 4 (Life-threatening) | Up to 2 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Complete Response Rate (CR) | CR is defined as the number of subjects who received the study treatment, achieved complete response (CR) by the Lugano classification. | Participants started the study treatment. | Posted | Count of Participants | Participants | Up to 4 months (End of Treatment) |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from the start of study treatment until death, during which participants show no disease progression per Lugano criteria Progressive Disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new fluorodeoxyglucose (FDG) -avid foci consistent with lymphoma at the interim or end-of-treatment assessment on PET, or an individual node/lesion must be abnormal with LDi > 1.5 cm, increase by ≥ 50% from the cross product of the shortest axis perpendicular to LDi (SDi) nadir and an increase in LDi or SDi from nadir: 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions > 2 cm. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
| Secondary | Overall Survival (OS) | OS is the time from treatment start until death from any cause; participants still alive are censored. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
| Secondary | Number of Participants With Adverse Events | The number of participants with adverse events will be listed and tabulated by grade to determine the safety and toxicity. Adverse Events will be graded according to The National Cancer Institute (NCI) of Common Terminology Criteria for Adverse Events (CTCAE) version 5. The scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events | The number of participants with adverse events (AEs) will be tabulated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. AEs are reported with specific terms where possible (e.g., bacteremia, kidney infection, sepsis) under each Organ System Class to avoid repetition. Each AE term is graded as follows: Grade 1 (Mild; asymptomatic or mild symptoms, no intervention), Grade 2 (Moderate; minimal intervention, limits instrumental Activities of Daily Living), Grade 3 (Severe; hospitalization or disabling, limits self-care Activities of Daily Living), and Grade 4 (Life-threatening) | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
| 1 |
| 5 |
| 3 |
| 5 |
| 5 |
| 5 |
| Bacteremia | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| "Blood and lymphatic system disorders - Other, specify" | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Malaise | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Title | Measurements |
|---|---|
|
| Hypomagnesemia |
|
| Lymphocyte count decreased |
|
| Neutrophil count decreased |
|
| Hyponatremia |
|
| White blood cell decreased |
|
| Blood lactate dehydrogenase increased |
|
| Hypokalemia |
|
| Creatinine increased |
|
| Alkaline phosphatase increased |
|
| Hyperglycemia |
|
| Blood and lymphatic system disorders - Other, specify |
|
| Hypophosphatemia |
|
| Abdominal pain |
|
| Investigations - Other, specify |
|
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Fatigue |
|
| Hypocalcemia |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify |
|
| Hyperhidrosis |
|
| Musculoskeletal and connective tissue disorder - Other, specify |
|
| Peripheral sensory neuropathy |
|
| Renal and urinary disorders - Other, specify |
|
| Anorexia |
|
| Floaters |
|
| Chest wall pain |
|
| Cough |
|
| Diarrhea |
|
| Fever |
|
| Gastroesophageal reflux disease |
|
| Headache |
|
| Hematuria |
|
| Hypercalcemia |
|
| Hyperkalemia |
|
| Infections and infestations - Other, specify |
|
| Insomnia |
|
| Leukocytosis |
|
| Malaise |
|
| Muscle cramp |
|
| Nausea |
|
| Pneumonitis |
|
| Sinus tachycardia |
|
| Skin and subcutaneous tissue disorders - Other, specify |
|
| Sleep apnea |
|
| Thrush |
|
| Tinnitus |
|
| Urine discoloration |
|
| Title | Measurements |
|---|---|
|
| Sepsis |
|
| Blood and lymphatic system disorders - Other, specify |
|
| Bacteremia |
|