A Phase I, Multicenter, Dose Escalation Study of CAT-8015... | NCT00587457

NCT00587457

Status Module

Sponsor/Collaborators Module

Name	Class
Cambridge Antibody Technology	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAT-8015 5 microgram per kilogram (mcg/kg)	Experimental	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	Drug: CAT-8015 5 mcg/kg
CAT-8015 10 mcg/kg	Experimental	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	Drug: CAT-8015 10 mcg/kg
CAT-8015 20 mcg/kg	Experimental	Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	Drug: CAT-8015 20 mcg/kg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAT-8015 5 mcg/kg	Drug	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	An adverse event (AE) events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox. Treatment-emergent were events between administration of investigational product and Day 28 that were absent before treatment or that worsened relative to pretreatment state.	From start of study drug administration until 30 days after the last dose of study drug
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)	The vital sign abnormalities which require an action or intervention by the investigator, or a finding judged by the investigator were reported as an adverse event. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.	From start of study drug administration until 30 days after the last dose of study drug
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)	AEs observed in participants with clinically significant ECG abnormalities were assessed.	From start of study drug administration until 30 days after the last dose of study drug
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Positive Neutralizing Antibodies	Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of B-Cell Leukemia [(chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or Small lymphocytic leukemia (SLL)]
Measurable Disease
Disease characteristics: Participants with CLL or SLL are eligible if they have failed 2 or more prior courses of standard chemo and/or biologic therapy (example, Rituxan) and PLL will be eligible if they have failed at least one prior standard chemotherapeutic regimen. Medical indications for treatment include progressive disease-related symptoms, progressive cytopenias due to marrow involvement, progressive or painful splenomegaly or adenopathy, rapidly increasing lymphocytosis, autoimmune hemolytic anemia or thrombocytopenia and increased frequency of infections.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Participants with other cancers who meet eligibility criteria and have had less than 5 years of disease-free survival will be considered on a case-by-case basis
Life expectancy of greater than 6 months, as assessed by the principal investigator
Must be able to understand and sign the informed consent
Must be at least 18 years old
Female and Male participants agree to use an approved method of contraception during the study

Exclusion Criteria:

History of allogeneic bone marrow transplant.
Documented and ongoing central nervous system involvement with their malignant disease [history of central nervous system (CNS) involvement is not an exclusion criterion]
Pregnant or breast-feeding females
Participants who plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.
HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
Hepatitis B surface antigen positive
Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements.
Hepatic function: Serum transaminases [either alanine aminotransferase (ALT) or aspartate aminotransferase (AST)] or direct bilirubin greater than or equal to Grade 2, unless bilirubin is due to Gilbert's disease
Renal function: Serum creatinine clearance is less than or equal to 60 millilitre per minute (mL/min) as estimated by Cockcroft-Gault formula

Hematologic function:

The ANC less than 1000/cubic millimeter (cmm), or platelet count less than 50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (that is, potentially reversible with anti-neoplastic therapy).
A participant will not be excluded because of pancytopenia greater than or equal to Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies.
Baseline coagulopathy greater than or equal to grade 3 unless due to anticoagulant therapy

Pulmonary function:

- Participants with less than 50 percent (%) of predicted forced expiratory volume (FEV-1) or less than 50% of predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin concentration and alveolar volume. Note: Participants with no prior history of pulmonary illness are not required to have pulmonary function test (PFTs). FEV1 will be assessed after bronchodilator therapy.

Recent prior therapy:

Cytotoxic chemotherapy, corticosteroids (except stable doses of prednisone), whole body electron beam radiation therapy, hormonal, biologic or other standard or any investigational therapy of the malignancy for 3 weeks prior to entry into the trial.
Less than or equal to 1 month prior monoclonal antibody therapy (that is, rituximab)
Participants who are receiving or have received radiation therapy less than 3 weeks prior to study entry will not be excluded providing the volume of the bone marrow treated is less than 10% and also the participant has measurable disease outside the radiation report.
Any history of prior pseudomonas - exotoxin immunotoxin administrator

Contacts/Locations Module

Name	Affiliation	Role
Mark C Lanasa, M.D.,Ph.D	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Indianapolis	Indiana		United States
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

CAT-8015 5 microgram per kilogram (mcg/kg)

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Arm/Group Information

ID	Title	Description
BG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
BG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
BG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0003 BG0013 BG0025 BG00311

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

TEAEs

Title	Measurements
	OG0003 OG0013 OG0025

TESAEs

Primary

Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)

The vital sign abnormalities which require an action or intervention by the investigator, or a finding judged by the investigator were reported as an adverse event. TEAEs were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Posted

Number

Participants

From start of study drug administration until 30 days after the last dose of study drug

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG002

Primary

Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)

AEs observed in participants with clinically significant ECG abnormalities were assessed.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Posted

Number

Participants

From start of study drug administration until 30 days after the last dose of study drug

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Primary

Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)

An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 30 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Posted

Number

Participants

From start of study drug administration until 30 days after the last dose of study drug

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Primary

Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)

Objective response rate defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Posted

Number

Participants

Up to 2 years of post-treatment follow-up

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Primary

Best Overall Objective Tumor Response

Antitumor activity was assessed by best overall objective tumor response.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Posted

Number

Participants

Up to 2 years of post-treatment follow-up

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox

The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.

Safety population included all participants who received any treatment of moxetumomab pasudotox. Here 'n' signifies participants evaluable for specified categories, for each arm, respectively.

Posted

Median

Full Range

hour

Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)

Primary

Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox

The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.

Safety population included all participants who received any treatment of moxetumomab pasudotox. Here 'n' signifies participants evaluable for specified categories, for each arm, respectively.

Posted

Median

Full Range

nanogram per milliliter

Predose, 0.25 (During Infusion), 0.5 (End of Infusion), 1, 1.5, 2, 4, 8 and 12 hours postdose on Day 1 and 5; Predose and End of Infusion on Day 3

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)

Secondary

Number of Participants With Positive Neutralizing Antibodies

Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. It was used as a direct surrogate for biological activity based on the mechanism of action of this drug. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit greater than (>)50 percentage (%) of the binding of CAT-8015 to CD22 using an ELISA-based method.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Posted

Number

Participants

Up to end of treatment (4-6 weeks after the last dose)

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Secondary

Percentage Change From Baseline in Cluster of Differentiation 22 (CD22) Expression

Participants demonstrated CD22 expression on malignant cells at Screening and CD22 is a regulatory molecule that prevents the over activation of the immune system and the development of autoimmune diseases.

Safety population included all participants who received any treatment of moxetumomab pasudotox.

Posted

Mean

Standard Deviation

Percentage

End of treatment (4-6 weeks after the last dose)

ID	Title	Description
OG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
OG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CAT-8015 5 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	1	3	3	3
EG001	CAT-8015 10 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	2	3	3	3
EG002	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	3	5	5	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Acute pulmonary histoplasmosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Neutropenic infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Blood calcium increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Hypothyroidism	Endocrine disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Vision blurred	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0021 events1 affected5 at risk
Oral pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Chills	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Localised oedema	General disorders	MedDRA 13.1	Systematic Assessment	EG0005 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Oedema	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk
Oedema peripheral	General disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Cystitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Histoplasmosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Rhinitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Blood albumin decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events1 affected3 at risk EG0023 events2 affected5 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Blood glucose decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Blood glucose increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0003 events2 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Blood magnesium decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0020 events0 affected5 at risk
Blood magnesium increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events1 affected3 at risk EG0020 events0 affected5 at risk
Blood phosphorus decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Blood potassium decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Blood sodium decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Blood sodium increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Blood triglycerides increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Blood uric acid increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Haemoglobin decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0006 events3 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected5 at risk
Lymphocyte count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Neutrophil count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Platelet count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0003 events2 affected3 at risk EG0012 events1 affected3 at risk EG0021 events1 affected5 at risk
Protein urine present	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Urine output decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
White blood cell count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected5 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0003 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Anxiety	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected5 at risk
Confusional state	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Depression	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG0020 events0 affected5 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Urinary retention	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected5 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected3 at risk EG0021 events1 affected5 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected5 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected5 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk
Capillary leak syndrome	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected5 at risk

The study was terminated early due to unavailability of investigational product.

Certain Agreements

ID	Term
D007938	Leukemia
D008223	Lymphoma
D015463	Leukemia, Prolymphocytic
D002547	Cerebral Palsy
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D007945	Leukemia, Lymphoid
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D015448	Leukemia, B-Cell
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C541974	immunotoxin HA22

Title	Measurements
	OG0001 OG0012 OG0023

Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.