Trial · NCT02271945
Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
NCT02271945, Phase 1, Phase 2, Completed, MedImmune LLC; results first posted 2018-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas. Trials, record NCT02271945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02271945
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
- NCT number
- NCT02271945
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Relapsed/Refractory Aggressive B-cell Lymphomas
- Interventions
- MEDI-551 12 mg/kg, MEDI0680 2.5 mg/kg, MEDI0680 10 mg/kg
- First posted
- 2014-10-22
- Last updated
- 2018-03-12
- Results first posted
- 2018-03-12
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of MEDI-551 | Day 1 to Day 28 of Cycle 1 (28-day cycle) | 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. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs) | From treatment administration to 90-days after last dose of study drug (up to approximately 2 years) | 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). |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities | From treatment administration to 90-days after last dose of study drug (up to approximately 2 years) | 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. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities | From treatment administration to 90-days after last dose of study drug (up to approximately 2 years) | 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. |
| Primary | Number of Participants With Best Overall Response | Day 1 to Day 28 of Cycle 13 (28-day cycle) | 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). |
| Secondary | Mean Peak and Trough Concentrations of MEDI551 | End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1 | 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. |
| Secondary | Mean Peak and Trough Concentrations of MEDI0680 | EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1 | 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. |
| Secondary | Terminal Half-Life (t1/2) of MEDI551 | EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1 | Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum. |
| Secondary | Terminal Half-Life (t1/2) of MEDI0680 | EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1 | Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum. |
| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680 | 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) | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of MEDI-551 | Day 1 to Day 28 of Cycle 1 (28-day cycle) | 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. | mg/kg | NUMBER |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs) | From treatment administration to 90-days after last dose of study drug (up to approximately 2 years) | As-treated Population included all participants who were treated with study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities | From treatment administration to 90-days after last dose of study drug (up to approximately 2 years) | As-treated Population included all participants who were treated with study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities | From treatment administration to 90-days after last dose of study drug (up to approximately 2 years) | As-treated Population included all participants who were treated with study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Best Overall Response | Day 1 to Day 28 of Cycle 13 (28-day cycle) | As-treated Population included all participants who were treated with study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Peak and Trough Concentrations of MEDI551 | End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1 | As-treated Population included all participants who were treated with study drug. | mcg/mL | MEAN |
| SECONDARY | Mean Peak and Trough Concentrations of MEDI0680 | EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1 | As-treated Population included all participants who were treated with study drug. | mcg/mL | MEAN |
| SECONDARY | Terminal Half-Life (t1/2) of MEDI551 | EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1 | As-treated Population included all participants who were treated with study drug. | h | MEAN |
| SECONDARY | Terminal Half-Life (t1/2) of MEDI0680 | EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1 | As-treated Population included all participants who were treated with study drug. | h | MEDIAN |
| SECONDARY | Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680 | 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) | As-treated Population included all participants who were treated with study drug. | Participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of MEDI-551 | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | NA | mg/kg | ||
| Maximum Tolerated Dose (MTD) of MEDI-551 | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | NA | mg/kg | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | TEAEs | 5 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | TEAEs | 5 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | TESAEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs) | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | TESAEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | Febrile neutropenia | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | Febrile neutropenia | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | Hypoglobulinaemia | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | Hypoglobulinaemia | 1 | Participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 5 | |
| Overall Study | STARTED | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 5 | |
| Overall Study | COMPLETED | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 0 | |
| Overall Study | COMPLETED | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 5 | |
| Overall Study | NOT COMPLETED | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 5 |
Source ClinicalTrials.gov
Adverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoglobulinaemia | Blood and lymphatic system disorders | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 0 | 5 | 0 |
| other | Hypoglobulinaemia | Blood and lymphatic system disorders | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 1 | 5 | 1 |
| other | Vision blurred | Eye disorders | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 1 | 5 | 1 |
| other | Vision blurred | Eye disorders | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 1 | 5 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 1 | 5 | 1 |
| other | Constipation | Gastrointestinal disorders | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 2 | 5 | 2 |
| other | Constipation | Gastrointestinal disorders | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 1 | 5 | 1 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 3 | 5 |
| Total, all-cause mortality | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 3 | 5 |
| Total, other adverse events | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 5 | 5 |
| Total, other adverse events | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 5 | 5 |
| Total, serious adverse events | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | 2 | 5 |
| Total, serious adverse events | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | 1 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg vs MEDI-551 12 mg/kg and MEDI0680 10 mg/kg: Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680 | Trial comparisons |
| MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg vs MEDI-551 12 mg/kg and MEDI0680 10 mg/kg: deaths from any cause | Trial comparisons |
| MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg vs MEDI-551 12 mg/kg and MEDI0680 10 mg/kg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02271945
GET https://conductscience.org/api/trials/v1/NCT02271945/results?page=2