Trial · NCT01453205
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
NCT01453205, 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. A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Trials, record NCT01453205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01453205
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- NCT number
- NCT01453205
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 187 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- MEDI-551 2 mg/kg, Rituximab, ICE, DHAP, Autologous Stem Cell Transplant (ASCT), MEDI-551 4 mg/kg
- First posted
- 2011-10-17
- 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 | Objective Response Rate (ORR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Objective Response Rate is defined as the proportion of participants with a best response of complete response (CR) or partial response (PR) according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50 percent (%) decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant nodal masses and greater than or equal to (\>=) 50% decrease in SPD of spleen/liver nodules. |
| Secondary | Progression-Free Survival (PFS) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Progression-free survival (PFS) is defined as the time from randomization until the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions. PFS (months) = (Date of PD/death or censoring - Date of randomization + 1) / (365.25/12). |
| Secondary | Event-Free Survival (EFS) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Event-Free Survival (EFS) is defined as the time from randomization until the first documentation of EFS events which include PD, initiation of alternative antitumor treatment or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions. EFS (months) = (Date of EFS or censoring - Date of randomization + 1) / (365.25/12). |
| Secondary | Overall Survival (OS) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Overall survival is defined as the time from randomization until death due to any cause according to the International Working Group criteria. OS (months) = (Date of death or censoring - Date of randomization + 1) / (365.25/12). |
| Secondary | Time to Progression (TTP) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Time to Progression (TTP) is defined as the time from randomization until the first documentation of PD according to the International Working Group criteria. PD is defined as appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions. TTP (months) = (Date of PD or censoring - Date of randomization + 1) / (365.25/12). |
| Secondary | Time to Response (TTR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Time to response (TTR) is defined as the time from randomization until the first documentation of disease response according to the International Working Group criteria. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and \>= 50% decrease in SPD of spleen/liver nodules. TTR (months) = (Date of first disease response - Date of randomization + 1) / (365.25/12). |
| Secondary | Duration of Response (DR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Duration of Response (DR) is defined as time from start of first documented objective response (confirmed CR or confirmed PR) to first documented PD according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and \>= 50% decrease in SPD of spleen/liver nodules. PD: appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \> 50% increase from nadir in the SPD of any previous lesions. Only participants who have achieved objective response assessed by investigator were evaluated. DR calculated as (months) = (Date of PD or censoring - Date of first disease response + 1)/ (365.25/12). |
| Secondary | Number of Participants With Best Overall Response Assessed by Blinded Independent Central Review (BICR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | 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: CR, PR, stable disease (SD), PD, and unknown. Responses were assessed according to the International Working Group criteria. CR: disappearance of all evidence of disease; PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and \>= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or \>= 50% increase in SPD of more than one node or \>= 50% increase in longest diameter of a previously identified node or \>50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD. |
| Secondary | Acceptable Dose of MEDI-551 | After the administration of the first dose of MEDI-551 (7 days before the Cycle 1) to last dose of MEDI-551 (Cycle 3 Day 1) (each cycle of 21 days) | Acceptable dose for MEDI-551 was evaluated based on the benefit-risk analysis. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | 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. Serious adverse event (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). |
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 | Objective Response Rate (ORR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Intent-To-Treat population included all participants who were randomized into the study. | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Intent-To-Treat population included all participants who were randomized into the study. | months | MEDIAN |
| SECONDARY | Event-Free Survival (EFS) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Intent-To-Treat population included all participants who were randomized into the study. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Intent-To-Treat population included all participants who were randomized into the study. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Intent-To-Treat population included all participants who were randomized into the study. | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | ITT population included all participants who were randomized into the study. Here, N is number of participants analyzed for this outcome measure. | months | MEDIAN |
| SECONDARY | Duration of Response (DR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Intent-To-Treat population included all participants who were randomized into the study. Here, N is number of participants analyzed for this outcome measure. | months | MEDIAN |
| SECONDARY | Number of Participants With Best Overall Response Assessed by Blinded Independent Central Review (BICR) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | ITT population included all participants who were randomized into the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Acceptable Dose of MEDI-551 | After the administration of the first dose of MEDI-551 (7 days before the Cycle 1) to last dose of MEDI-551 (Cycle 3 Day 1) (each cycle of 21 days) | All participants who were randomized into the study and received MEDI-551. | milligram per kilogram (mg/kg) | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant) | Safety population included all participants who received any study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group306
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Rituximab+ ICE/DHAP | 47.5 | 95% Confidence Interval 36.2 to 59.0 | Percentage of participants | |
| Objective Response Rate (ORR) | MEDI-551 2 mg/kg + ICE/DHAP | 46.2 | 95% Confidence Interval 32.2 to 60.5 | Percentage of participants | |
| Objective Response Rate (ORR) | MEDI-551 4 mg/kg + ICE/DHAP | 43.6 | 95% Confidence Interval 30.3 to 57.7 | Percentage of participants | |
| Progression-Free Survival (PFS) | Rituximab+ ICE/DHAP | 6.1 | Full Range 0.0 to 39.2 | months | |
| Progression-Free Survival (PFS) | MEDI-551 2 mg/kg + ICE/DHAP | 6.6 | Full Range 0.0 to 31.3 | months | |
| Progression-Free Survival (PFS) | MEDI-551 4 mg/kg + ICE/DHAP | 7.7 | Full Range 0 to 14.8 | months | |
| Event-Free Survival (EFS) | Rituximab+ ICE/DHAP | 4.7 | Full Range 0.0 to 39.2 | months | |
| Event-Free Survival (EFS) | MEDI-551 2 mg/kg + ICE/DHAP | 4.2 | Full Range 0.0 to 31.3 | months | |
| Event-Free Survival (EFS) | MEDI-551 4 mg/kg + ICE/DHAP | 5.9 | Full Range 0.0 to 14.8 | months | |
| Overall Survival (OS) | Rituximab+ ICE/DHAP | NA | 95% Confidence Interval 15.6 to NA | months |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab+ ICE/DHAP | 80 | |
| Overall Study | STARTED | MEDI-551 2 mg/kg + ICE/DHAP | 52 | |
| Overall Study | STARTED | MEDI-551 4 mg/kg + ICE/DHAP | 55 | |
| Overall Study | COMPLETED | Rituximab+ ICE/DHAP | 0 | |
| Overall Study | COMPLETED | MEDI-551 2 mg/kg + ICE/DHAP | 0 | |
| Overall Study | COMPLETED | MEDI-551 4 mg/kg + ICE/DHAP | 1 | |
| Overall Study | NOT COMPLETED | Rituximab+ ICE/DHAP | 80 | |
| Overall Study | NOT COMPLETED | MEDI-551 2 mg/kg + ICE/DHAP | 52 | |
| Overall Study | NOT COMPLETED | MEDI-551 4 mg/kg + ICE/DHAP | 54 |
Source ClinicalTrials.gov
Adverse events570
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 | Anaemia | Blood and lymphatic system disorders | Rituximab+ ICE/DHAP | 47 | 79 | 113 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI-551 2 mg/kg + ICE/DHAP | 32 | 52 | 87 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI-551 4 mg/kg + ICE/DHAP | 33 | 54 | 111 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rituximab+ ICE/DHAP | 6 | 79 | 6 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | MEDI-551 2 mg/kg + ICE/DHAP | 2 | 52 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | MEDI-551 4 mg/kg + ICE/DHAP | 3 | 54 | 4 |
| other | Granulocytopenia | Blood and lymphatic system disorders | Rituximab+ ICE/DHAP | 3 | 79 | 5 |
| other | Granulocytopenia | Blood and lymphatic system disorders | MEDI-551 2 mg/kg + ICE/DHAP | 0 | 52 | 0 |
| other | Granulocytopenia | Blood and lymphatic system disorders | MEDI-551 4 mg/kg + ICE/DHAP | 2 | 54 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab+ ICE/DHAP | 8 | 79 | 10 |
1 to 10 of 570Source ClinicalTrials.gov
See all 570 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab+ ICE/DHAP | ||
| Total, all-cause mortality | MEDI-551 2 mg/kg + ICE/DHAP | ||
| Total, all-cause mortality | MEDI-551 4 mg/kg + ICE/DHAP | ||
| Total, other adverse events | Rituximab+ ICE/DHAP | 78 | 79 |
| Total, other adverse events | MEDI-551 2 mg/kg + ICE/DHAP | 49 | 52 |
| Total, other adverse events | MEDI-551 4 mg/kg + ICE/DHAP | 52 | 54 |
| Total, serious adverse events | Rituximab+ ICE/DHAP | 33 | 79 |
| Total, serious adverse events | MEDI-551 2 mg/kg + ICE/DHAP | 25 | 52 |
| Total, serious adverse events | MEDI-551 4 mg/kg + ICE/DHAP | 27 | 54 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MEDI-551 2 mg/kg + ICE/DHAP vs MEDI-551 4 mg/kg + ICE/DHAP: Number of Participants Who Developed Detectable MEDI-551 Anti-drug Antibodies (ADA) |
Source 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/NCT01453205
GET https://conductscience.org/api/trials/v1/NCT01453205/results?page=2