| Primary | Phase 1: Recommended Dose of Brentuximab Vedotin in Combination With Doxorubicin, Vinblastine, and Dacarbazine in a Pediatric Population | The recommended dose was determined after considering all safety data in phase 1 and assessing for dose limiting toxicities (DLTs) which are defined as the dose range at which less than or equal to (<=) 1 of 6 evaluable participants experience DLT within the defined observation period (Cycle 1 + 28 days). This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The DLT-evaluable population included participants who had received at least 1 dose of study drug therapy and experienced a DLT or no DLT during the DLT observation period. Participants who received granulocyte colony stimulating factor (G-CSF) during the DLT observation period were excluded from the DLT-Evaluable Population. | Posted | | Number | | mg/m^2 | | From the first dose (Cycle 1) up to Day 56 (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 56 days. |
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| Primary | Phase 1: Percentage of Participants Who Experienced Adverse Events (AEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen). | Posted | | Number | | percentage of participants | | From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants who received at least one dose of study in Phase 1 and continued to receive the study drug in Phase 2 were included in this arm group. |
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| Primary | Phase 1: Percentage of Participants Who Experienced Serious Adverse Events (SAEs) From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, Is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, Is a congenital anomaly/birth defect, Is a medically important event. | The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen). | Posted | | Number | | percentage of participants | | From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants who received at least one dose of study in Phase 1 and continued to receive the study drug in Phase 2 were included in this arm group. |
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| Primary | Phase 2: Percentage of Participants Who Achieved a Complete Remission (CR) Per Independent Review Facility (IRF) Assessment Per International Working Group (IWG) Criteria at End of Treatment (EOT) Visit | CR was defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in the statistical analysis plan (SAP) , data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At end of treatment (EOT) visit 30 days after the last dose of study drug (at Month 7) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD |
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| Primary | Phase 2: Percentage of Participants Whose Disease Was Positron Emission Tomography (PET) Negative After 2 Cycles of Protocol Therapy Per IRF Assessment | The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans. PET negative after Cycle 2 was defined as an IRF Deauville score of (1 or 2 or 3). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | | percentage of participants | | From first dose of study drug up to Cycle 2 Day 25 (Each Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Primary | Phase 2: Percentage of Participants Who Achieved a Partial Remission (PR) Per IRF Assessment Per IWG Criteria at EOT Visit | PR was defined as regression of measurable disease and no new sites as assessed by IRF as per IWG criteria. Percentage of participants in the response-evaluable population who achieved a partial response based on the IRF assessment at the EOT visit based on the IWG criteria are reported. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At EOT visit 30 days after the last dose of study drug (at Month 7) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD |
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| Primary | Phase 2: Percentage of Participants Who Achieved an Overall Response Rate (ORR) Per IRF Assessment Per IWG Criteria at EOT Visit | Overall response rate was defined as the percentage of participants with CR or PR as assessed by IRF using IWG criteria. CR was defined as the disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new diseases. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At EOT visit 30 days after the last dose of study drug (at Month 7) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD |
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| Primary | Phase 2: Percentage of Participants Who Were Able to Complete 6 Cycles of Protocol Therapy at the Recommended Dose | This outcome measure was planned to be assessed for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen). | Posted | | Number | | percentage of participants | | From first dose of study drug up to Cycle 6 (Each Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Mean Maximum Observed Serum Concentration (Cmax) of Brentuximab Vedotin Total Conjugated and Therapeutic Antibody (TAb) | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | microgram per milliliter(mcg/mL) | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Mean Maximum Observed Plasma Concentration (Cmax) of Monomethyl Auristatin E (MMAE) | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/ml) | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Mean Area Under the Serum Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of Brentuximab Vedotin and TAb | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | day*microgram per milliliter(day*mcg/mL) | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Mean Area Under the Plasma Concentration-Time Curve From Day 0 to Day 15 (AUC0-15) of MMAE | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | day* nanogram per milliliter (day*ng/mL) | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Median Time to Reach Cmax (Tmax) of Brentuximab Vedotin and TAb in Serum | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. | Posted | | Median | Full Range | hour | | Cycle 1-6: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Median Time to Reach Cmax (Tmax) of MMAE in Plasma | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Median | Full Range | hour | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants Who Achieved a CR Per IRF Assessment Per IWG Criteria at EOT Visit | CR was defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At EOT visit 30 days after the last dose of study drug (at Month 7) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants Who Achieved a PR Per IRF Assessment Per IWG Criteria at EOT Visit | PR was defined as regression of measurable disease and no new diseases as per IWG Criteria based on IRF. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At EOT visit 30 days after the last dose of study drug (at Month 7) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants Who Achieved an ORR Per IRF Assessment Per IWG Criteria at EOT Visit | Overall response rate was defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria. CR was defined as the disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. The confidence interval was based on exact binomial distribution (Clopper-Pearson method). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At EOT visit 30 days after the last dose of study drug (at Month 7) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants Whose Disease Was PET Negative After 2 Cycles of Protocol Therapy Per IRF Assessment | The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans. PET negative after Cycle 2 was defined as an IRF Deauville score of (1 or 2 or 3). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm. | Response-evaluable population included participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment based on an independent review facility. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first dose of study drug up to Cycle 2 (Each Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants Whose Disease Was PET Positive After 6 Cycles of Protocol Therapy Per IRF Assessment | The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans. PET positive after Cycle 6 defined as an IRF Deauville score of (4 or 5). This outcome measure was planned to be assessed only for participants treated in Phase 1 arm. | This outcome measure was planned to be assessed only for participants treated in Phase 1 arm. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first dose of study drug up to Cycle 6 (Each Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants Who Were Antitherapeutic Antibody (ATA) Positive, Persistently Positive or Transiently Positive, and Neutralizing Antitherapeutic Antibody (nATA) Positive | ATA positive was defined as participants who have a positive ATA in any postbaseline sample. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. Persistently ATA positive was defined as participants who have positive ATA in more than 2 postbaseline timepoints. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. nATA positive was defined as participants who have at least one positive nATA in any postbaseline ATA positive sample. Here, percentage of participants who were transiently or persistently ATA positive are considered as ATA positive. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | Immunogenicity population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment. | Posted | | Number | | percentage of participants | | Up to 7 months | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 +AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Progression-free Survival (PFS) | PFS per IRF:time from first dose until disease progression per IRF/death due to any cause,whichever occurred first.Participants with no objective progressive disease (PD),did not die,were still on study follow-up at time of analysis were removed from study prior to documentation of PD,PFS was censored on date of last adequate disease assessment before initiation of any non-protocol,alternative therapy.Participants who were on antitumor treatment,other than SCT/radiotherapy,censoring was at last adequate disease assessment before initiation of such alternative treatment.If participant experienced disease progression per IRF/died after initiation of antitumor treatment,other than SCT/radiotherapy,such participant was censored and not considered having PFS.Outcome measure was planned to be assessed for all participant treated at recommended dose in Phase 2.As per SAP,Phase 2 data was summarized and reported in two arms:Phase 2 and Phase 1 + Phase 2. | The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen. | Posted | | Median | 95% Confidence Interval | months | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | |
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| Secondary | Phase 2: Event-free Survival (EFS) | EFS:Time from first dose until any treatment failure:PD per IRF including progression events during follow-up period,failing to complete 6 cycles of treatment due to any reason or death due to any cause,whichever occurred first.EFS per IRF were censored on last adequate disease assessment date per IRF if none of above events occur during study.Participants with antitumor treatment,other than SCT/radiotherapy as part of frontline treatment were censored at last adequate disease assessment before initiation of such alternative treatment.If a participant experienced disease progression per IRF/died after initiation of antitumor treatment,other than SCT/radiotherapy,such participant was censored,and not be considered having EFS.This outcome measure was planned to be assessed for all patients treated at recommended dose in Phase 2.As prespecified in SAP,data for Phase 2 was summarized and reported in two arms:Phase 2 and Phase 1 + Phase 2. | The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen. For participants who do not have an objective PD and did not die at the last follow-up, EFS has been censored on the date of last adequate disease assessment. | Posted | | Median | 95% Confidence Interval | months | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. |
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| Secondary | Phase 2: Overall Survival (OS) | Overall survival was defined as time from first dose until death. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive, including study closure. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen. | Posted | | Median | 95% Confidence Interval | months | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Duration of Response (DOR) | DOR per IRF in participants with a response (CR or PR per IRF) was defined as the time from start of the first objective tumor response (CR or PR per IRF) to the first subsequent PD or death due to any cause, whichever occurred first. For patients who did not have an objective PD, did not die and are either still on a study follow-up at the time of the analysis, or were removed from the study prior to documentation of PD, DOR has been censored on the date of last adequate disease assessment. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Response Evaluable Population=Participants who received at least one dose of study drug, have measurable disease at baseline, and have at least one post-baseline disease assessment (assessments based on investigator assessments or assessments based on an independent review facility). For participants who do not have an objective PD and did not die at the last follow-up, DOR has been censored on the date of last adequate disease assessment. | Posted | | Median | 95% Confidence Interval | months | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. |
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| Secondary | Phase 2: Percentage of Participants Receiving Irradiation for HL Following Study Treatment | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The safety/efficacy population included participants who received at least 1 dose of any drug in the A+AVD regimen. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Percentage of Participants Who Experienced AEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen). | Posted | | Number | | percentage of participants | | From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Percentage of Participants Who Experienced SAEs From the First Dose of Protocol Therapy Through 30 Days After Administration of the Last Dose of Protocol Therapy | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The safety population included participants who had received at least 1 dose of any study drug (A+AVD regimen). | Posted | | Number | | percentage of participants | | From first dose in Cycle 1 Day 1 until 30 days after the last dose of study drug in Cycle 6 Day 15 (up to Cycle 7 Day 15) (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Percentage of Participants Who Were ATA Positive, Persistently Positive, or Transiently Positive, and nATA Positive | ATA positive was defined as participants who have a positive ATA in any postbaseline sample. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. Persistently ATA positive was defined as participants who have positive ATA in more than 2 postbaseline timepoints. Transiently ATA positive was defined as participants who have positive ATA in 1 or 2 postbaseline samples. nATA positive was defined as participants who have at least one positive nATA in any postbaseline ATA positive sample. Here, percentage of participants who were transiently or persistently ATA positive are considered as ATA positive. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immunogenicity population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment. | Posted | | Number | | percentage of participants | | From first dose until 30 days after the last dose of study drug (up to 7 months) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. |
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| Secondary | Phase 2: Mean Serum Cmax of Brentuximab Vedotin and TAb | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | µg/mL | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Mean Plasma Cmax of MMAE | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | ng/mL | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Mean Serum AUC0-15d of Brentuximab Vedotin and TAb | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | day*µg/mL | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Mean Plasma AUC0-15 of MMAE | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | day*ng/mL | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Median Tmax of Brentuximab Vedotin and TAb in Serum | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Median | Full Range | hour | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Median Tmax of MMAE in Plasma | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Median | Full Range | hour | | Days 1 and 15 of Cycles 1 and 3 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Percentage of Participants Who Experienced Peripheral Neuropathy, Regardless of Seriousness, From the First Dose of Protocol Therapy | Peripheral Neuropathy (PN) was defined by the peripheral neuropathy standardized MedDRA query (SMQ) broad search. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The safety population included participants who received at least 1 dose of any drug in the A+AVD regimen. | Posted | | Number | | percentage of participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Time to Onset and Resolution for All Peripheral Neuropathy Events | Time to onset of first event was defined as time from first dose of study drug to onset of first treatment-emergent PN event. Time to resolution was calculated as the time from onset date to the date of resolution PN (SMQ) event. Participants with multiple resolved events were counted once at the longest time to resolution. Resolution was defined as an event outcome of resolved or resolved with sequelae. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The safety population included participants who received at least 1 dose of any drug in the A+AVD regimen. Overall number analyzed signifies participants who had peripheral neuropathy were analyzed for this outcome measure, number analyzed are participants with evaluable for the specific category. | Posted | | Median | Full Range | weeks | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline Immunoglobulin G Levels at End of Treatment (EOT) | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | g/L | | Baseline and End of Treatment (Month 7) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants With Low and High ATA Titer Values | High ATA titer was defined as participants who have at least one postbaseline ATA titer less than (>) 25. Low ATA titer was defined as participants whose postbaseline ATA titer are all less than or equal to (<=) 25. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | Immunogenicity population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment. | Posted | | Number | | percentage of participants | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Percentage of Participants With Low and High ATA Titer Values | High ATA titer was defined as participants who have at least one postbaseline ATA titer >25. Low ATA titer was defined as participants whose postbaseline ATA titer are all <=25. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immunogenicity population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment. | Posted | | Number | | percentage of participants | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | µg/mL | | Cycle 1 and 3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Mean AUC 0-15d of Brentuximab Vedotin in ATA Positive and ATA Negative Participants | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | day*µg/mL | | Cycle 1 and 3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Percentage of Participants Achieving CR Per IRF Assessment Per IWG Criteria in ATA Positive and ATA Negative Participants | CR was defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. The data is reported per ATA status as categories. This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | Immunogenicity population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 1: Number of ATA Positive and ATA Negative Participants With AEs and SAEs | This outcome measure is planned to be assessed only for participants treated in Phase 1 arm. | The Safety Population included participants who received at least 1 dose of any drug in the A+AVD regimen, with data available for analyses. Data is reported as per ATA positive and negative status. | Posted | | Count of Participants | | Participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 1: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants who received at least one dose of study in Phase 1 and continued to receive the study drug in Phase 2 were included in this arm group. |
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| Secondary | Phase 2: Mean Cmax of Brentuximab Vedotin in ATA Positive and ATA Negative Participants | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | µg/mL | | Cycle 1-3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Mean AUC 0-15 of Brentuximab Vedotin in ATA Positive and ATA Negative Participants | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The PK population included participants with sufficient data to enable calculation of at least 1 PK parameter. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | day*µg/mL | | Cycle 1-3: Days 1 and 15 pre-infusion and up to 30 minutes after the end of infusion (Cycle length=28 days) | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Percentage of Participants Achieving CR Per IRF Assessment Per IWG Criteria in ATA Positive and ATA Negative Participants | CR is defined as the disappearance of all evidence of disease as assessed by IRF as per IWG Criteria. This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immunogenicity Population included participants who received at least 1 dose of study drug and had the baseline immunogenicity sample and at least 1 postbaseline immunogenicity sample assessment. Number analyzed is the number of participants analyzed for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Number of ATA Positive and ATA Negative Participants With AEs and SAEs | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | The Safety Population included participants who received at least 1 dose of any drug in the A+AVD regimen. Data is reported as per ATA positive and negative status. | Posted | | Count of Participants | | Participants | | Up to 24 months | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in Immunoglobulin M at the End of Treatment (EOT) | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation, with data available for analyses. Number analyzed is number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | g/L | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in Immunoglobulin A at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | g/L | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in Tetanus at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed =number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | (IU)/mL | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in Haemophilus Influenzae B Antibody, IgG at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | µg/mL | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline Poliovirus Antibodies Ratio at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | ratio | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline Total Immunoglobulin at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | mg/dl | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in Peripheral Blood CD34+A at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | µL | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in Total Lymphocyte Count at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. | Posted | | Mean | Standard Deviation | 10^9 lymphocytes/L | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD4+ (CD4+CD45RA-CD197- and CD4+CD45RA+CD197+) Subset of Cells at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | percentage of CD4+ subset cells | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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| Secondary | Phase 2: Immune Reconstitution-Change From Baseline in the Percentage of CD8+ (CD8+CD45RA-CD197- and CD8+CD45RA-CD197+) Subset of Cells at EOT | This outcome measure was planned to be assessed only for all participants treated at the recommended dose in Phase 2. As prespecified in SAP, data for Phase 2 was summarized and reported in two arms: Phase 2 and Phase 1 + Phase 2. | Immune Reconstitution Population included participants who received at least 1 dose of study drug and had a sufficient immune reconstitution blood sampling to allow for immune reconstitution evaluation. Overall number analyzed are the number of participants with data available for analyses. Number analyzed= number of participants with data available for analysis at the given time point. | Posted | | Mean | Standard Deviation | percentage of CD8+ subset cells | | Baseline, EOT [Month 7] | | | | ID | Title | Description |
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| OG000 | Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. Participants enrolled in Phase 2 were included. | | OG001 | Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD | Brentuximab vedotin 48 mg/m^2 (A), intravenous infusion, once on Days 1 and 15 of each 28-day cycle approximately 1 hour after administration of doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 (AVD), intravenous infusion, once on Days 1 and 15 of each 28-day cycle for up to 6 cycles. |
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