Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL (NCT NCT02910063)

NCT ID: NCT02910063

Last Updated: 2021-01-13

Results Overview

Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 41 participants
• Primary outcome timeframe: Up to 12 weeks after first dose of blinatumomab
• Results posted on: 2021-01-13

Participant Flow

Participants were enrolled at 19 research centers in Australia, Belgium, Italy, Spain, the United Kingdom, and the United States from 23 January 2017 to 15 January 2018.

Phase 3 part of the study was not initiated after Phase 2 data was reviewed. No participants were screened or enrolled for Phase 3.

Participant milestones

Measure	Phase 2: Blinatumomab Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Blinatumomab Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
Phase 2 STARTED	41	0	0
Phase 2 Started Cycle 1	41	0	0
Phase 2 Started Optional Cycle 2	4	0	0
Phase 2 COMPLETED	13	0	0
Phase 2 NOT COMPLETED	28	0	0
Phase 3 STARTED	0	0	0
Phase 3 COMPLETED	0	0	0
Phase 3 NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Phase 2: Blinatumomab Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Blinatumomab Participants were to enter a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.
Phase 2 Withdrawal by Subject	3	0	0
Phase 2 Lost to Follow-up	1	0	0
Phase 2 Death	24	0	0

Baseline Characteristics

Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL

Baseline characteristics by cohort

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.
Age, Continuous	54.7 Years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks after first dose of blinatumomab

Population: FAS: All participants who received blinatumomab.

Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)	22.0 Percentage of participants Interval 10.6 to 37.6	—	—

PRIMARY outcome

Timeframe: Up to 12 weeks after first dose of study treatment

Population: No data is available for Phase 3. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled.

Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization until the end of study, up to 30 months

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

OS was defined as the time from the date of randomization until death due to any cause.

OS was calculated using Kaplan-Meier estimates.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Overall Survival (OS)	11.2 Months Interval 5.9 to Upper limit was not reached.	—	—

SECONDARY outcome

Timeframe: Up to 12 weeks after first dose of blinatumomab

Population: FAS: All participants who received blinatumomab.

ORR is inclusive of all participants who achieved CMR or those who achieved partial metabolic response (PMR), as determined by central radiographic assessment of PET/CT scans using the Lugano Classification.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Objective Response Rate (ORR)	36.6 Percentage of participants Interval 22.1 to 53.1	—	—

SECONDARY outcome

Timeframe: From first dose of blinatumomab until the end of study, up to 30 months

Population: FAS: All participants who received blinatumomab.

PFS was defined as the time from start of treatment with blinatumomab until the date of diagnosis of progression of lymphoma, or date of death, whichever is earliest. PFS was estimated using Kaplan-Meier method.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Progression Free Survival (PFS)	2.9 Months Interval 2.3 to 5.3	—	—

SECONDARY outcome

Timeframe: From first dose of blinatumomab up to 12 weeks

Population: Full Analysis Set (FAS): All participants who received blinatumomab.

DOR was calculated only for participants who achieve a response (CMR or PMR). The duration was calculated from the date a response, CMR or PMR, was first achieved until the earliest date of a disease assessment indicating disease progression or death, whichever occured first. DOR was estimated using Kaplan-Meier method.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Duration of Response (DOR)	6.1 Months Interval 2.5 to 10.7	—	—

SECONDARY outcome

Timeframe: From first dose of blinatumomab until the end of study, up to 30 months

Population: Responder Analysis Set: All participants who had a CMR or PMR per central review during the first 12 weeks after initiation of blinatumomab.

Successful mobilization rate was defined as the percentage of participants who initiated mobilization while in remission and without any other anti-tumor therapy where the mobilization procedure had an outcome of 'Successful'. Successful mobilization was dictated by institutional standards and defined when the target cell dose was no less than 2 x 10^6 CD34+ cells/kg.

Outcome measures

Measure	Phase 2: Blinatumomab n=15 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Percentage of Participants Who Experienced Successful Mobilization	40.0 Percentage of participants Interval 16.3 to 67.7	—	—

SECONDARY outcome

Timeframe: From baseline HSCT until the end of study, up to 30 months

Population: FAS: All participants who received blinatumomab.

The percentage of responders per investigator's review (participants who achieved either CMR or PMR during the treatment) who have undergone allogeneic (allo) HSCT or autologous (auto) HSCT while in remission and without any other anti-cancer treatment.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT) AlloHSCT	6.7 Percentage of participants Interval 0.2 to 31.9	—	—
Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT) AutoHSCT	53.3 Percentage of participants Interval 26.6 to 78.7	—	—

SECONDARY outcome

Timeframe: 100 days after HSCT

Population: AutoHSCT Analysis Set: All participants who achieved a response and underwent autoHSCT while in remission and without any other anti-cancer treatment.

Non-relapse mortality rate at 100 days after HSCT was calculated as the percentage of participants who died not due to relapse. Only participants who achieved a response per investigator's review and underwent autoHSCT are included.

Outcome measures

Measure	Phase 2: Blinatumomab n=9 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Cumulative Incidence Function Estimate of 100-day Mortality After HSCT Presented as Percentage of Participants That Died Not Due to Relapse, With Relapse and Death Due to Relapse as Competing Events	0.0 Percentage of participants Interval 0.0 to 0.0	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

Population: PK analysis Set: All subjects who received blinatumomab at each individual dose and had at least one PK sample collected.

Pharmacokinetic (PK) parameters were estimated by non compartmental analysis. The Css of blinatumomab was summarized as the observed concentrations collected after at least 24 hours after the start of continuous IV infusion or start of dose step, where appropriate.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy n=38 Participants Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day n=32 Participants All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Blinatumomab Steady State Concentrations (Css)	249 Picograms/millilter (pg/mL) Standard Deviation 200	804 Picograms/millilter (pg/mL) Standard Deviation 513	3470 Picograms/millilter (pg/mL) Standard Deviation 3700

SECONDARY outcome

Timeframe: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

Population: PK analysis Set: All subjects who received any infusion of blinatumomab and had at least one PK sample collected.

Serum blinatumomab CL was calculated as CL=R0/Css,DN; where R0 is the infusion rate (μg/hr) and Css,DN is the dose normalized average Css. For the CL calculation, the Css,DN was normalized to the 112 μg/day dose in which the value of dose in units of μg/hr was used for the infusion rate.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Blinatumomab Clearance (CL)	1.78 Liter/hour (L/hr) Standard Deviation 0.747	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

Population: Blinatumomab half-life was not reported as the serum blinatumomab concentration data collected for PK assessments did not support its estimation. This is in adherence with the considerations for reporting of PK assessments as detailed in Protocol Section 10.6.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days

Treatment-emergent adverse events were events with an onset after the administration of the first dose of blinatumomab.

TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE).

Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL).

Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.

Grade 4 Life-threatening consequences; urgent interventions indicated.

Outcome measures

Measure	Phase 2: Blinatumomab n=41 Participants Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.	Phase 3: Investigator's Choice (IC) Chemotherapy Participants were to receive standard of care (SOC) chemotherapy per investigator´s choice. In March 2019, the decision was made to not proceed with Phase 3 and no participants were enrolled. No data is available for Phase 3.	Phase 2: Blinatumomab 112 µg/Day All participants who received blinatumomab 112 µg/day continuous infusion which was administered for 7 days in Week 3 of Cycle 1 (Cycle 1 was 70 days in length).
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) TEAEs	41 Participants	—	—
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade ≥ 2 TEAEs	37 Participants	—	—
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade ≥ 3 TEAEs	29 Participants	—	—
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Grade ≥ 4 TEAEs	12 Participants	—	—
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Serious TEAEs	20 Participants	—	—
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) TEAEs leading to discontinuation of blinatumomab	7 Participants	—	—
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) TEAEs leading to interruption of blinatumomab	13 Participants	—	—
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Fatal TEAEs	7 Participants	—	—

SECONDARY outcome

Timeframe: Up to 12 weeks after first dose of study treatment

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until the end of study, up to 30 months

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment up to 12 weeks

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline until the end of study, up to 30 months

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline HSCT until the end of study, up to 30 months

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 100 days after HSCT

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after last dose after study treatment

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study treatment until 30 days after last dose

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours after first dose of blinatumomab

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)

Population: No data is available for Phase 3. In March 2019, the decision made to not proceed with Phase 3 and no participants were enrolled.

Outcome measures

Outcome data not reported

Adverse Events

Phase 2: Blinatumomab

Serious events: 20 serious events

Other events: 29 other events

Deaths: 25 deaths

Serious adverse events

Measure	Phase 2: Blinatumomab n=41 participants at risk Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.
Cardiac disorders Atrial fibrillation	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Gastrointestinal disorders Abdominal pain	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Gastrointestinal disorders Pancreatitis acute	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
General disorders Pyrexia	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Infections and infestations Bacteraemia	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Infections and infestations Lower respiratory tract infection	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Infections and infestations Pneumonia	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Infections and infestations Sepsis	4.9% 2/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Infections and infestations Staphylococcal bacteraemia	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Musculoskeletal and connective tissue disorders Pain in extremity	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma refractory	4.9% 2/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Nervous system disorders Hemiparesis	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Nervous system disorders Neurotoxicity	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Psychiatric disorders Confusional state	7.3% 3/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Vascular disorders Deep vein thrombosis	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Vascular disorders Orthostatic hypotension	2.4% 1/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.

Other adverse events

Measure	Phase 2: Blinatumomab n=41 participants at risk Participants entered a single 70-day dose step cycle, and received a total of 56 days of blinatumomab continuous infusion which was administered as 7 days at 9 microgram (μg)/day, 7 days at 28 μg/day, and 42 days at 112 μg/day, followed by a treatment-free period of 14 days. Eligible participants could then enter an optional Cycle 2, 2 to 4 weeks after the end of the previous cycle. The optional Cycle 2 consisted of a 28-day cycle of blinatumomab continuous infusion administered as 7 days at 9 μg/day, 7 days at 28 μg/day, and 14 days at 112 μg/day.
Blood and lymphatic system disorders Anaemia	14.6% 6/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Blood and lymphatic system disorders Neutropenia	12.2% 5/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Gastrointestinal disorders Abdominal pain	9.8% 4/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Gastrointestinal disorders Constipation	14.6% 6/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Gastrointestinal disorders Diarrhoea	9.8% 4/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Gastrointestinal disorders Nausea	14.6% 6/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Gastrointestinal disorders Stomatitis	7.3% 3/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
General disorders Asthenia	7.3% 3/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
General disorders Fatigue	9.8% 4/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
General disorders Oedema peripheral	19.5% 8/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
General disorders Pyrexia	22.0% 9/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Metabolism and nutrition disorders Hypoalbuminaemia	9.8% 4/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Metabolism and nutrition disorders Hypomagnesaemia	12.2% 5/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 4/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Musculoskeletal and connective tissue disorders Back pain	22.0% 9/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Musculoskeletal and connective tissue disorders Pain in extremity	9.8% 4/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Nervous system disorders Aphasia	7.3% 3/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Nervous system disorders Headache	24.4% 10/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Nervous system disorders Paraesthesia	7.3% 3/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Nervous system disorders Tremor	22.0% 9/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Psychiatric disorders Confusional state	9.8% 4/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Psychiatric disorders Insomnia	12.2% 5/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Respiratory, thoracic and mediastinal disorders Cough	7.3% 3/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.
Vascular disorders Hypotension	7.3% 3/41 • From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days All-cause mortality, serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. No data is available for Phase 3. In March 2019, decision made to not proceed with Phase 3 and no participants were enrolled. The data below is only inclusive of participants in Phase 2.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER