Relapsed/Refractory Aggressive B-cell LymphomasPhase 1/2NCT02271945
Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
A Phase 1/2 study testing MEDI-551 12 mg/kg, MEDI0680 2.5 mg/kg and MEDI0680 10 mg/kg in people with Relapsed/Refractory Aggressive B-cell Lymphomas, run by MedImmune LLC at 6 sites in United States.
Trial summary
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Relapsed/Refractory Aggressive B-cell Lymphomas
- What is being tested?
- MEDI-551 12 mg/kg, MEDI0680 2.5 mg/kg and MEDI0680 10 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Dec 2014to 24 May 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed aggressive diffuse large B-cell lymphoma (DLBCL), including follicular lymphoma (FL) transforming to DLBCL, transformed indolent lymphoma, mantle cell lymphoma (MCL), or Grade 3B FL for dose-escalation cohorts. Only participants with DLBCL will be enrolled in the dose-expansion cohort.
- Willing to provide a fresh tumor sample
- Evaluable/measurable disease with measurable disease defined as greater than or equal to (>= 1) lesion less than or equal to (<=) 20 mm in one dimension or ≥ 15 mm in 2 dimensions as measured by conventional or high-resolution (spiral) computed tomography (CT). Disease evaluable by the International Working Group criteria (Cheson et al, 2007). (NOTE: Irradiated lesions will not be evaluable.)
- Baseline fludeoxyglucose positron emission tomography (FDG-PET) or FDG-PET/CT scans must show positive lesions compatible with CT-defined anatomical tumor sites.
- Relapsed from or refractory to >= 2 prior chemotherapy regimens with >= 1 regimen containing rituximab or failed 1 prior rituximab-containing regimen and unable to tolerate additional multiagent chemotherapy. NOTE: Subjects enrolled in the dose-escalation portion of the study must have exhausted all available standard therapy.
- At least 100 days past autologous stem cell transplant (ASCT).
Show all 12Show fewer
- At least 1 year past allogeneic stem-cell transplant (SCT) and off immunosuppression therapy, with no evidence of graft-versus-host disease.
- Eastern Cooperative Oncology Group performance status 0-2.
- Adequate hematological function
- Adequate organ function
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 180 days after the final dose of investigational product.
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1through 90 days after receipt of the final dose of investigational product.
Who cannot join
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer.
- Receipt of any experimental therapy, mAb, cancer vaccine, chemotherapy or small molecule within 28 days prior to Cycle 1 Day 1 or 5 half-lives of that therapy, whichever is shorter.
- Previous therapy directed against cluster of differentiation 19 (CD19)
- Prior exposure to immunotherapy such as but not limited to other anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), anti-PD 1, or anti-PD-L1 antibodies excluding cancer vaccines.
- Vaccination with a live virus within 28 days prior to receiving the first dose of study drug
- History of other invasive malignancy within 2 years except for cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.
Show all 19Show fewer
- Evidence of significant active infection requiring antimicrobial, antifungal, antiparasitic, or antiviral therapy or for which other supportive care is given unless the subject is clinically stable.
- Human immunodeficiency virus (HIV) positive serology or acquired immunodeficiency syndrome (AIDS).
- Active hepatitis B
- Ongoing >= Grade 2 toxicities from previous cancer therapies or any unresolved > Grade 1 immune-related adverse event (irAE) event unless specifically allowed in the inclusion/exclusion criteria.
- No immunosuppressive therapy within 14 days of Cycle 1 Day 1 of MEDI0680 (AMP-514) dosing.
- Active or prior documented autoimmune or inflammatory disease except vitiligo.
- History of primary immunodeficiency.
- Major surgical procedures (as defined by the principal investigator) within 28 days of Cycle 1 Day 1 or still recovering from prior surgery.
- History of tuberculosis, including those who may have completed prophylactic isoniazid (INH) therapy.
- Documented current central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression.
- Pregnancy or lactation.
- Clinically significant abnormality on electrocardiogram (ECG).
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, current pneumonitis, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from MEDI-551 or MEDI0680 (AMP-514), or compromise the ability of the subject to give written informed consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Baltimore, Maryland, 21231
Research Site
Birmingham, Alabama, 36294-3300
Research Site
Cleveland, Ohio, 44195
Research Site
Milwaukee, Wisconsin, 53226
Research Site
St Louis, Missouri, 63110
Research Site
The Bronx, New York, 10467
About this study
Official title: A Phase 1b/2 Open-label Study to Evaluate the Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapy in Subjects With Relapsed or Refractory Aggressive B-cell Lymphomas
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy.
Read the detailed description
This is a Phase 1b/2, multicenter, open-label, study of MEDI-551 in combination with immunomodulating therapy evaluating the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity in subjects with relapsed or refractory aggressive B-cell lymphomas
- Being tested
- MEDI-551 12 mg/kg, MEDI0680 2.5 mg/kg, MEDI0680 10 mg/kg
- Keywords
- aggressive lymphoma, DLBCL, NHL
- Medical subject headings
- Recurrence, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-551 12 mg/kgDrug
Participants will receive intravenous (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
MEDI0680 2.5 mg/kgDrug
Participants will receive 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.
MEDI0680 10 mg/kgDrug
Participants will receive 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.
| Study group | Role | What they receive |
|---|---|---|
| MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | Experimental | Participants will receive intravenous (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. Receives: Drug: MEDI-551 12 mg/kg; Drug: MEDI0680 2.5 mg/kg |
| MEDI-551 12 mg/kg and MEDI0680 10 mg/kg | Experimental | Participants will receive 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. Receives: Drug: MEDI-551 12 mg/kg; Drug: MEDI0680 10 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of MEDI-551
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.
Measured: Day 1 to Day 28 of Cycle 1 (28-day cycle)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs)
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).
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
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.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities
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.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Number of Participants With Best Overall Response
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).
Measured: Day 1 to Day 28 of Cycle 13 (28-day cycle)
Secondary outcomes (11)
Mean Peak and Trough Concentrations of MEDI551
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.
Measured: End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1
Mean Peak and Trough Concentrations of MEDI0680
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.
Measured: EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1
Terminal Half-Life (t1/2) of MEDI551
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1
Terminal Half-Life (t1/2) of MEDI0680
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Measured: EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1
Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680
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.
Measured: 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)
Duration of Complete Response
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.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Number of Participants With Disease Control
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.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Duration of Disease Control
Duration of disease control is defined as the time period from the start of disease control event to the event of disease progression.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Progression-free Survival (PFS)
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.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Overall Survival (OS)
Overall survival defined as the time from the start of study drug administration until death due to any cause.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Time to Response (TTR)
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.
Measured: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start1 Dec 2014
- Primary completion24 May 2016
- Study completion24 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed/Refractory Aggressive B-cell LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MedImmune LLC, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271945
- Sponsor's protocol ID
- D2852C00004
- Status last verified
- Feb 2018
- First submitted
- 23 Sep 2014
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Open-label Study to Evaluate the Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapy in Subjects With Relapsed or Refractory Aggressive B-cell Lymphomas
- ClinicalTrials.gov ID
- NCT02271945
- Acronym / sponsor ID
- D2852C00004
- Keywords
- aggressive lymphoma, DLBCL, NHL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 24 May 2016 (actual)
- Study completion
- 24 May 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy.
Detailed description
This is a Phase 1b/2, multicenter, open-label, study of MEDI-551 in combination with immunomodulating therapy evaluating the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity in subjects with relapsed or refractory aggressive B-cell lymphomas
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg | Experimental | Drug: MEDI-551 12 mg/kg, Drug: MEDI0680 2.5 mg/kgParticipants will receive intravenous (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 | Experimental | Drug: MEDI-551 12 mg/kg, Drug: MEDI0680 10 mg/kgParticipants will receive 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed aggressive diffuse large B-cell lymphoma (DLBCL), including follicular lymphoma (FL) transforming to DLBCL, transformed indolent lymphoma, mantle cell lymphoma (MCL), or Grade 3B FL for dose-escalation cohorts. Only participants with DLBCL will be enrolled in the dose-expansion cohort.
- Willing to provide a fresh tumor sample
- Evaluable/measurable disease with measurable disease defined as greater than or equal to (>= 1) lesion less than or equal to (<=) 20 mm in one dimension or ≥ 15 mm in 2 dimensions as measured by conventional or high-resolution (spiral) computed tomography (CT). Disease evaluable by the International Working Group criteria (Cheson et al, 2007). (NOTE: Irradiated lesions will not be evaluable.)
- Baseline fludeoxyglucose positron emission tomography (FDG-PET) or FDG-PET/CT scans must show positive lesions compatible with CT-defined anatomical tumor sites.
- Relapsed from or refractory to >= 2 prior chemotherapy regimens with >= 1 regimen containing rituximab or failed 1 prior rituximab-containing regimen and unable to tolerate additional multiagent chemotherapy. NOTE: Subjects enrolled in the dose-escalation portion of the study must have exhausted all available standard therapy.
Key exclusion criteria (19 listed)
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer.
- Receipt of any experimental therapy, mAb, cancer vaccine, chemotherapy or small molecule within 28 days prior to Cycle 1 Day 1 or 5 half-lives of that therapy, whichever is shorter.
- Previous therapy directed against cluster of differentiation 19 (CD19)
- Prior exposure to immunotherapy such as but not limited to other anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), anti-PD 1, or anti-PD-L1 antibodies excluding cancer vaccines.
- Vaccination with a live virus within 28 days prior to receiving the first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI-551 12 mg/kgParticipants will receive intravenous (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 | Drug | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg, MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg |
| MEDI0680 2.5 mg/kgParticipants will receive 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. | Drug | MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg |
| MEDI0680 10 mg/kgParticipants will receive 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. | Drug | MEDI-551 12 mg/kg and MEDI0680 10 mg/kg |
Primary outcome
Maximum Tolerated Dose (MTD) of MEDI-551
Time frame: 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: 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).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
Time frame: 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities
Time frame: 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.
Number of Participants With Best Overall Response
Time frame: 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).
11 secondary outcomes
Mean Peak and Trough Concentrations of MEDI551
Time frame: End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1
Mean Peak and Trough Concentrations of MEDI0680
Time frame: EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1
Terminal Half-Life (t1/2) of MEDI551
Time frame: EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1
Terminal Half-Life (t1/2) of MEDI0680
Time frame: EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1
Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680
Time frame: 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)
Duration of Complete Response
Time frame: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Number of Participants With Disease Control
Time frame: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Duration of Disease Control
Time frame: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Progression-free Survival (PFS)
Time frame: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Overall Survival (OS)
Time frame: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Time to Response (TTR)
Time frame: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Relapsed/Refractory Aggressive B-cell Lymphomas
RecruitingPhase 2
Bispecific Antibody-Based Holding/Bridging Therapy Before CAR-T in Aggressive B-Cell Lymphomas
Aggressive B-cell Non-Hodgkin Lymphoma (aNHL), Relapsed or Refractory B-cell Lymphoma
RecruitingPhase 2
Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL
Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma
RecruitingPhase 1
SynKIR-310 for Relapsed/Refractory B-NHL
B Cell Lymphoma, NHL, Adult
Not yet recruitingPhase 1/2
Clinical Study of SYS6055 Injection in Participants With Relapsed/Refractory Aggressive B-Cell Lymphoma
Relapsed/Refractory Aggressive B-Cell Lymphoma
RecruitingPhase 2
Bispecific Antibody-Based Salvage Therapy Followed by CAR-T ± ASCT in R/R Aggressive B-Cell Lymphoma
Relapsed or Refractory Aggressive B-cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MedImmune LLC study director
MedImmune LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MEDI-551 12 mg/kg, MEDI0680 2.5 mg/kg and MEDI0680 10 mg/kg in people with Relapsed/Refractory Aggressive B-cell Lymphomas, run by MedImmune LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of MEDI-551 (time frame: Day 1 to Day 28 of Cycle 1 (28-day cycle)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.