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Trial Outcomes & Findings for Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas (NCT NCT02271945)

NCT ID: NCT02271945

Last Updated: 2018-03-12

Results Overview

The Maximum Tolerated Dose, defined as the highest dose where less than or equal to (\<= 1) out of 6 subjects experiences a dose limiting toxicity (DLT) during the DLT evaluation period (Day 1 to Day 28 of Cycle 1) or the highest protocol specified dose not exceeding MTD.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Day 1 to Day 28 of Cycle 1 (28-day cycle)

Results posted on

2018-03-12

Participant Flow

The study was conducted from 01Dec2014 to 24May2016.

A total of 16 participants were screened in this study. Of which, 6 participants failed screening and 10 participants were enrolled in the study and received the study drugs.

Participant milestones

Participant milestones
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Overall Study
STARTED
5
5
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
5
5

Reasons for withdrawal

Reasons for withdrawal
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Overall Study
Death
3
3
Overall Study
Withdrawal by Subject
1
1
Overall Study
Other
1
1

Baseline Characteristics

Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
TOTAL
n=10 Participants
Total of all reporting groups
Age, Continuous
63.2 YEARS
STANDARD_DEVIATION 7.1 • n=99 Participants
63.8 YEARS
STANDARD_DEVIATION 14.8 • n=107 Participants
63.5 YEARS
STANDARD_DEVIATION 11.0 • n=206 Participants
Age, Customized
< 65 YEARS
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Age, Customized
>= 65 YEARS
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
2 Participants
n=107 Participants
3 Participants
n=206 Participants
Sex: Female, Male
Male
4 Participants
n=99 Participants
3 Participants
n=107 Participants
7 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
White
4 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 28 of Cycle 1 (28-day cycle)

Population: Evaluable Population for DLT included all participants in the dose escalation portion who received all protocol assigned doses and completed safety follow-up during the first 28-day period of therapy, or experienced a DLT during the DLT evaluation period.

The Maximum Tolerated Dose, defined as the highest dose where less than or equal to (\<= 1) out of 6 subjects experiences a dose limiting toxicity (DLT) during the DLT evaluation period (Day 1 to Day 28 of Cycle 1) or the highest protocol specified dose not exceeding MTD.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=3 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=4 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Maximum Tolerated Dose (MTD) of MEDI-551
NA mg/kg
The study was terminated before the MTD was reached.
NA mg/kg
The study was terminated before the MTD was reached.

PRIMARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug.

An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. SAE is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
5 Participants
5 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
2 Participants
1 Participants

PRIMARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug.

An abnormal laboratory findings that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as 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 90 days after the end of study drug.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Febrile neutropenia
1 Participants
0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Hypoglobulinaemia
0 Participants
1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Blood alkaline phosphatase increased
0 Participants
1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Blood creatinine increased
1 Participants
0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Blood pressure increased
1 Participants
0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Lymphocyte count decreased
0 Participants
2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Neutrophil count decreased
0 Participants
1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Platelet count decreased
0 Participants
1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
White blood cell count decreased
0 Participants
1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Hyperglycaemia
0 Participants
2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Hyperuricaemia
1 Participants
0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Hypocalcaemia
0 Participants
1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Hyponatraemia
0 Participants
1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Haematuria
1 Participants
0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Proteinuria
0 Participants
1 Participants

PRIMARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug.

Vital signs included parameters such as blood pressure, temperature, respiratory rate, and pulse oximetry. An abnormal vital signs and physical findings that was judged by the investigator to be medically significant was reported an AE. TEAEs were defined as 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 90 days after the end of study treatment.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities
Infusion related reaction
1 Participants
2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities
Pyrexia
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 28 of Cycle 13 (28-day cycle)

Population: As-treated Population included all participants who were treated with study drug.

The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: complete response (disappearance of all evidence of disease), partial response (regression of measurable disease and no new sites), stable disease (SD), progessive disease (PD), and non- evaluable (NE).

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Number of Participants With Best Overall Response
Complete Response
0 Participants
1 Participants
Number of Participants With Best Overall Response
Partial Response
0 Participants
0 Participants
Number of Participants With Best Overall Response
Stable Disease
0 Participants
1 Participants
Number of Participants With Best Overall Response
Progressive Disease
5 Participants
3 Participants
Number of Participants With Best Overall Response
Non-evaluable
0 Participants
0 Participants

SECONDARY outcome

Timeframe: End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1

Population: As-treated Population included all participants who were treated with study drug.

The mean peak and Trough concentration of MEDI551 were observed. Peak is the end of infusion measurement and the Trough is the pre-dose measurement.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Mean Peak and Trough Concentrations of MEDI551
Cycle1 Day1 End of Infusion
244 mcg/mL
Standard Deviation 49.3
220 mcg/mL
Standard Deviation 66.2
Mean Peak and Trough Concentrations of MEDI551
C1D8 Predose
103 mcg/mL
Standard Deviation 13.3
96.8 mcg/mL
Standard Deviation 38.3
Mean Peak and Trough Concentrations of MEDI551
C1D8 End of Infusion
329 mcg/mL
Standard Deviation 63.4
313 mcg/mL
Standard Deviation 74.2
Mean Peak and Trough Concentrations of MEDI551
C2D1 Predose
92.4 mcg/mL
Standard Deviation 36.3
103 mcg/mL
Standard Deviation 45.4
Mean Peak and Trough Concentrations of MEDI551
C2D1 End of Infusion
276 mcg/mL
Standard Deviation 59.1
336 mcg/mL
Standard Deviation 76.1
Mean Peak and Trough Concentrations of MEDI551
C3D1 Predose
109 mcg/mL
Standard Deviation 26.8
108 mcg/mL
Standard Deviation 49.9
Mean Peak and Trough Concentrations of MEDI551
C3D1 End of Infusion
325 mcg/mL
Standard Deviation 71.8
300 mcg/mL
Standard Deviation 55.2
Mean Peak and Trough Concentrations of MEDI551
C4D1 Predose
85.7 mcg/mL
Standard Deviation NA
Standard Deviation was not evaluable as insufficient number of participants.
111 mcg/mL
Standard Deviation 57.2
Mean Peak and Trough Concentrations of MEDI551
C4D1 End of Infusion
338 mcg/mL
Standard Deviation NA
Standard Deviation was not evaluable as insufficient number of participants.
292 mcg/mL
Standard Deviation 77.8

SECONDARY outcome

Timeframe: EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1

Population: As-treated Population included all participants who were treated with study drug.

The mean peak and Trough concentration of MEDI0680 were observed. Peak is the end of infusion measurement and the Trough is the pre-dose measurement.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Mean Peak and Trough Concentrations of MEDI0680
C1D2 End of Infusion
49.8 mcg/mL
Standard Deviation 18.2
256 mcg/mL
Standard Deviation 101
Mean Peak and Trough Concentrations of MEDI0680
C1D15 Predose
18.7 mcg/mL
Standard Deviation 2.10
109 mcg/mL
Standard Deviation 30.1
Mean Peak and Trough Concentrations of MEDI0680
C1D15 End of Infusion
72.5 mcg/mL
Standard Deviation 12.4
298 mcg/mL
Standard Deviation 41.7
Mean Peak and Trough Concentrations of MEDI0680
C2D1 Predose
32.8 mcg/mL
Standard Deviation 6.31
178 mcg/mL
Standard Deviation 52.3
Mean Peak and Trough Concentrations of MEDI0680
C2D1 End of Infusion
92.9 mcg/mL
Standard Deviation 17.1
339 mcg/mL
Standard Deviation 55.9
Mean Peak and Trough Concentrations of MEDI0680
C3D1 Predose
44.1 mcg/mL
Standard Deviation 3.25
277 mcg/mL
Standard Deviation 64.3
Mean Peak and Trough Concentrations of MEDI0680
C3D1 End of Infusion
110 mcg/mL
Standard Deviation 29.6
590 mcg/mL
Standard Deviation NA
Standard Deviation was not evaluable as insufficient number of participants.
Mean Peak and Trough Concentrations of MEDI0680
C4D1 Predose
62.2 mcg/mL
Standard Deviation NA
Standard Deviation was not evaluable as insufficient number of participants.
364 mcg/mL
Standard Deviation 77.1
Mean Peak and Trough Concentrations of MEDI0680
C4D1 End of Infusion
86.0 mcg/mL
Standard Deviation NA
Standard Deviation was not evaluable as insufficient number of participants.
595 mcg/mL
Standard Deviation NA
Standard Deviation was not evaluable as insufficient number of participants.

SECONDARY outcome

Timeframe: EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1

Population: As-treated Population included all participants who were treated with study drug.

Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Terminal Half-Life (t1/2) of MEDI551
NA h
t1/2 could not be determined because the participants were not followed for the sufficiently long time.
NA h
t1/2 could not be determined because the participants were not followed for the sufficiently long time.

SECONDARY outcome

Timeframe: EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1

Population: As-treated Population included all participants who were treated with study drug.

Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Terminal Half-Life (t1/2) of MEDI0680
NA h
t1/2 could not be determined because the participants were not followed for the sufficiently long time.
NA h
t1/2 could not be determined because the participants were not followed for the sufficiently long time.

SECONDARY outcome

Timeframe: 30 min prior to infusion of MEDI-551 on Day 1 of Cycles 1, 2, 6, 9, and 12 and up to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug.

A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study.

Outcome measures

Outcome measures
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 Participants
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680
1 Participants
0 Participants

SECONDARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.

Duration of Complete Response defined as time from start of first documented Complete Response \[CR\] to the time of disease progression or death, whichever occurs first. Only participants who have achieved complete response assessed by investigator were evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.

Disease control includes CR (disappearance of all evidence of disease), PR (regression of measurable disease and no new sites), or SD for at least 8 weeks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.

Duration of disease control is defined as the time period from the start of disease control event to the event of disease progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.

Progression-free survival (PFS) is defined as the time from the start of study drug administration until the first documentation of disease progression or death due to any cause, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.

Overall survival defined as the time from the start of study drug administration until death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)

Population: As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.

Time to response (TTR) defined as the time from the start of study drug administration until the first documentation of disease response. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR.

Outcome measures

Outcome data not reported

Adverse Events

MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg

Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths

MEDI-551 12 mg/kg and MEDI0680 10 mg/kg

Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 participants at risk
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 participants at risk
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Blood and lymphatic system disorders
Febrile neutropenia
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Cardiac disorders
Atrial fibrillation
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Investigations
Blood creatinine increased
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma recurrent
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)

Other adverse events

Other adverse events
Measure
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
n=5 participants at risk
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
n=5 participants at risk
Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Blood and lymphatic system disorders
Hypoglobulinaemia
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Eye disorders
Vision blurred
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Abdominal distension
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Abdominal pain
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Constipation
40.0%
2/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Diarrhoea
40.0%
2/5 • Number of events 3 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Dysphagia
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Gastrooesophageal reflux disease
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Nausea
40.0%
2/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Stomatitis
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Gastrointestinal disorders
Vomiting
20.0%
1/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
General disorders
Chills
20.0%
1/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
General disorders
Fatigue
40.0%
2/5 • Number of events 3 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
60.0%
3/5 • Number of events 3 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
General disorders
Oedema peripheral
40.0%
2/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
General disorders
Pyrexia
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Infections and infestations
Device related infection
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Infections and infestations
Sinusitis
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Infections and infestations
Upper respiratory tract infection
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Injury, poisoning and procedural complications
Infusion related reaction
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
40.0%
2/5 • Number of events 5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Investigations
Blood alkaline phosphatase increased
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Investigations
Blood pressure increased
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Investigations
Lymphocyte count decreased
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
40.0%
2/5 • Number of events 4 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Investigations
Neutrophil count decreased
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Investigations
Platelet count decreased
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Investigations
White blood cell count decreased
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
40.0%
2/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
40.0%
2/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Metabolism and nutrition disorders
Hyperuricaemia
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Metabolism and nutrition disorders
Vitamin b12 deficiency
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Musculoskeletal and connective tissue disorders
Back pain
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Musculoskeletal and connective tissue disorders
Joint stiffness
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Nervous system disorders
Dizziness
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Nervous system disorders
Headache
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Nervous system disorders
Neuropathy peripheral
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Nervous system disorders
Paraesthesia
40.0%
2/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Nervous system disorders
Sciatica
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Psychiatric disorders
Anxiety
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Psychiatric disorders
Depression
40.0%
2/5 • Number of events 2 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Psychiatric disorders
Insomnia
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Psychiatric disorders
Stress
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Renal and urinary disorders
Haematuria
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Renal and urinary disorders
Proteinuria
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
40.0%
2/5 • Number of events 3 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders
Pleural effusion
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders
Productive cough
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 4 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Skin and subcutaneous tissue disorders
Rash
40.0%
2/5 • Number of events 6 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Skin and subcutaneous tissue disorders
Rash papular
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
Vascular disorders
Flushing
0.00%
0/5 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)
20.0%
1/5 • Number of events 1 • From treatment administration to 90 days after last dose of study drug (up to approximately 2 years)

Additional Information

Mohammed Dar

MedImmune, LLC

Phone: 301-398-4095

Results disclosure agreements

  • Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
  • Publication restrictions are in place

Restriction type: OTHER