| Primary | Maximum Tolerated Dose (MTD) | MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity [DLT]) in more than 30 percent (%) of participants. | Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT. | Posted | | Number | | mcg/Kg | | Day 1 to end of Cycle 1 (approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG002 | CAT-8015 40 Microgram Per Kilogram (mcg/kg) | Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG003 | CAT-8015 50 Microgram Per Kilogram (mcg/kg) | Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG004 | CAT-8015 60 Microgram Per Kilogram (mcg/kg) | Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000NAData was not reported as MTD was not reached in the specified arm group.
- OG001NAData was not reported as MTD was not reached in the specified arm group.
- OG002NAData was not reported as MTD was not reached in the specified arm group.
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| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Any Grade 3 or greater, non-hematological toxicity (including capillary leak syndrome [CLS] and thrombotic microangiopathy/ hemolytic uremic syndrome (HUS), Grade 3 or higher treatment-related hematologic toxicities and only ≥ Grade 3 thrombotic microangiopathy /HUS constituted a DLT with few exceptions. | Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT. | Posted | | Count of Participants | | Participants | | Day 1 to end of Cycle 1 (approximately 28 days) | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment. | Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety. | Posted | | Count of Participants | | Participants | | From Screening (Day -28) to Post Therapy Day 30 | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment. | Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety. | Posted | | Count of Participants | | Participants | | From Screening (Day -28) to Post Therapy Day 30 | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Primary | Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment. | Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety. | Posted | | Count of Participants | | Participants | | From Screening (Day -28) to Post Therapy Day 30 | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) | Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment. | Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety. | Posted | | Count of Participants | | Participants | | From Screening (Day -28) to Post Therapy Day 30 | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Secondary | Percentage of Participants With Complete Response (CR) | The CR rate was defined as the percentage of participants who had achieved CR based on both the evaluable population for efficacy. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Number | | Percentage of Participants | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
|---|
| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. |
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| Secondary | Duration of Complete Response | Duration of CR was measured from the first documentation of a CR to the time of relapse for the subgroup of participants with CR. Duration of CR was calculated using the Kaplan Meier method. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. | Posted | | Median | Full Range | Months | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
|---|
| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. |
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| Secondary | Percentage of Participants With Partial Response (PR) | | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Number | | Percentage of Participants | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
|---|
| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | |
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| Secondary | Percentage of Participants With Objective Response (OR) | OR was defined as the percentage of participants with CR or partial response (PR). | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Number | | Percentage of Participants | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
|---|
| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. |
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| Secondary | Time to Response (TTR) | TTR was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was only assessed in participants who had achieved objective response (OR). | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. | Posted | | Median | Full Range | Months | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
|---|
| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. |
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| Secondary | Duration of Objective Response (DOR) | DOR was measured from the first documentation of OR to the event of relapse. DOR was calculated using the Kaplan-Meier method. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. | Posted | | Median | Full Range | Months | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
|---|
| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. |
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| Secondary | Duration of Stable Disease (SD) | Duration of SD was defined as the time period from start of moxetumomab pasudotox administration to the event of progressive disease (PD)/relapse. Duration of SD was only calculated for the subgroup of participants with best response of CR, PR, or SD, and was calculated using the Kaplan-Meier method. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. | Posted | | Median | Full Range | Months | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
|---|
| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. |
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| Secondary | Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox | Maximum observed drug concentration of Moxetumomab pasudotox in plasma. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Secondary | Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox | Area under the concentration versus time curve from zero to infinity (AUC) of Moxetumomab pasudotox in Plasma. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Mean | Standard Deviation | hour*nanogram per milliliter (hr*ng/mL) | | Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Secondary | Clearance (CL) of Moxetumomab Pasudotox | CL of drug is rate at which drug is metabolized or eliminated by normal biological processes and is influenced by fraction of dose absorbed. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Mean | Standard Deviation | milliliter per hour per kilogram | | Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Secondary | Elimination Half Life (t1/2) of Moxetumomab Pasudotox | Plasma decay half life is the time measured for the plasma concentration to decrease by one half. | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Mean | Standard Deviation | hour | | Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Secondary | Number of Participants With Positive Anti-Drug Antibody | The moxetumomab pasudotox specific bridging assay using the Meso Scale Discovery platform was employed to detect anti-drug antibodies (ADA). | Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years) | | | | ID | Title | Description |
|---|
| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Secondary | Number of Participants With CD22 Expression Levels | CD22 Expression was analyzed using Prism® analysis. Flow cytometry was performed to quantitate the CD22 expression for the purpose of evaluating the relationship of CD22 expression with response to treatment. | Evaluable population for expression of CD22 on malignant cells included all participants with peripheral blood samples containing 10 or more B cells (CD19-positive cells) per cubic millimeter. | Posted | | Count of Participants | | Participants | | Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years) | | | | ID | Title | Description |
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| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. |
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| Secondary | Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs) | The correlation of CLS and weight changes, albumin, hypotension, edema, hypoxia, and pulmonary AEs were examined. | Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety. | Posted | | Count of Participants | | Participants | | From Screening (Day -28) to Post Therapy Day 30 | | | | ID | Title | Description |
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| OG000 | CAT-8015 20 Microgram Per Kilogram (mcg/kg) | Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. | | OG001 | CAT-8015 30 Microgram Per Kilogram (mcg/kg) | Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg. |
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| Secondary | Percentage of Participants With Stable Disease (SD) | | Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile. | Posted | | Number | | Percentage of Participants | | Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment) | | | | ID | Title | Description |
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| OG000 | Chronic Lymphocytic Leukemia | Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | | OG001 | Diffuse Large B Cell Lymphoma | Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg. | |
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