- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01466153
A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
April 20, 2017 updated by: MedImmune LLC
A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antwerpen, Belgium
- Research Site
-
Arlon, Belgium
- Research Site
-
Kortrijk, Belgium
- Research Site
-
Mons, Belgium
- Research Site
-
Wilrijk, Belgium
- Research Site
-
Yvoir, Belgium
- Research Site
-
-
-
-
Ontario
-
Toronto, Ontario, Canada
- Research Site
-
-
Quebec
-
Greenfield Park, Quebec, Canada
- Research Site
-
Montreal, Quebec, Canada
- Research Site
-
-
-
-
-
Amiens, France
- Research Site
-
Bayonne, France
- Research Site
-
Bordeaux, France
- Research Site
-
Le Mans, France
- Research Site
-
Libourne Cedex, France
- Research Site
-
Marseille, France
- Research Site
-
Nimes, France
- Research Site
-
-
-
-
-
Dortmund, Germany
- Research Site
-
Essen, Germany
- Research Site
-
Freiburg, Germany
- Research Site
-
Muenchen, Germany
- Research Site
-
Wuerzburg, Germany
- Research Site
-
-
-
-
-
Haifa, Israel
- Research Site
-
Ramat Gan, Israel
- Research Site
-
-
-
-
-
Bari, Italy
- Research Site
-
Lecce, Italy
- Research Site
-
Meldola, Italy
- Research Site
-
Milano, Italy
- Research Site
-
Modena, Italy
- Research Site
-
Napoli, Italy
- Research Site
-
Orbassano, Italy
- Research Site
-
Palermo, Italy
- Research Site
-
Pisa, Italy
- Research Site
-
Ravenna, Italy
- Research Site
-
Rimini, Italy
- Research Site
-
Roma, Italy
- Research Site
-
San Giovanni Rotondo, Italy
- Research Site
-
Torino, Italy
- Research Site
-
Udine, Italy
- Research Site
-
-
-
-
-
Gdynia, Poland
- Research Site
-
Warszawa, Poland
- Research Site
-
-
-
-
Alabama
-
Birmingham, Alabama, United States
- Research Site
-
-
California
-
Burbank, California, United States
- Research Site
-
La Jolla, California, United States
- Research Site
-
Palm Springs, California, United States
- Research Site
-
-
Illinois
-
Skokie, Illinois, United States
- Research Site
-
-
Louisiana
-
Shreveport, Louisiana, United States
- Research Site
-
-
Maryland
-
Baltimore, Maryland, United States
- Research Site
-
-
Michigan
-
Detroit, Michigan, United States
- Research Site
-
-
North Dakota
-
Fargo, North Dakota, United States
- Research Site
-
-
Ohio
-
Dayton, Ohio, United States
- Research Site
-
Newark, Ohio, United States
- Research Site
-
-
South Dakota
-
Watertown, South Dakota, United States
- Research Site
-
-
Texas
-
Lubbock, Texas, United States
- Research Site
-
-
West Virginia
-
Morgantown, West Virginia, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Adequate hematological function
Exclusion Criteria:
- Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
- Exposure to bendamustine within the 180 days before study enrollment
- Prior autologous or allogeneic stem cell transplantation (SCT);
- Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor;
- History of other invasive malignancy within 5 years except for localized/in situ carcinomas;
- Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Rituximab + Bendamustine
Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle.
Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles).
Bendamustine was administered before the administration of rituximab in each cycle.
|
Rituximab was administered by IV infusion as a dose of 375 mg/m^2 on Day 2 of Cycle 1 and then at 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycles
Other Names:
Bendamustine was administered by IV infusion as a dose of 70 mg/m^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.
|
EXPERIMENTAL: MEDI-551 2 mg/kg + Bendamustine
MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle.
Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles).
Bendamustine was administered before the administration of MEDI-551 in each cycle.
|
Bendamustine was administered by IV infusion as a dose of 70 mg/m^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.
MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.
|
EXPERIMENTAL: MEDI-551 4 mg/kg + Bendamustine
MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle.
Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles).
Bendamustine was administered before the administration of MEDI-551 in each cycle.
|
Bendamustine was administered by IV infusion as a dose of 70 mg/m^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.
MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
ORR, defined as the proportion of participants with complete response (CR) or partial response (PR) out of total number of participants.
Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)
Time Frame: From time of consent to 90 days post last dose
|
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug (MEDI-551).
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between administration of study drug and Day 90 that were absent before treatment or that worsened relative to pre-treatment state.
An AESIs was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor.
Treatment emergent AESIs were collected from the time of dosing through Day 90 after the last dose of study drug.Hepatic function abnormality and infusion reactions resulting in discontinuation were considered as AESIs.
|
From time of consent to 90 days post last dose
|
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs
Time Frame: From time of consent to 90 days post last dose
|
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event.
Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
|
From time of consent to 90 days post last dose
|
Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs
Time Frame: From time of consent to 90 days post last dose
|
AEs observed in participants with clinically significant ECG abnormalities were assessed.
|
From time of consent to 90 days post last dose
|
Complete Response Rate
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Complete response was as per IWG was the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Minimal Residual Disease Negative Complete Response (CR) Rate
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
The MRD-negative CR rate was defined as the percentage of participants who achieved CR and became MRD-negative as determined by flow cytometry.
CR as per International Working Group (IWG) was complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Time to Response
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Time to response was evaluated using the Kaplan-Meier method.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Time to Disease Progression (TTP)
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Progression Free Survival (PFS)
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
PFS was measured from the start of treatment with study drug until the first documentation of disease progression or death due to any cause, whichever occurred first.
Kaplan-Meier method was used for evaluation.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Overall Survival (OS)
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
OS was determined as the time from the start of treatment with study drug until death due to any cause.
For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive.
Kaplan-Meier method was used for evaluation.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA)
Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
|
From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
|
Terminal Half Life (t1/2) of MEDI-551
Time Frame: Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1
|
Terminal phase elimination half-life (T1/2) was the time required for half of the drug to be eliminated from the serum.
|
Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MedImmune, MedImmune LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 7, 2012
Primary Completion (ACTUAL)
January 8, 2016
Study Completion (ACTUAL)
January 8, 2016
Study Registration Dates
First Submitted
September 30, 2011
First Submitted That Met QC Criteria
November 4, 2011
First Posted (ESTIMATE)
November 6, 2011
Study Record Updates
Last Update Posted (ACTUAL)
May 31, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Bendamustine Hydrochloride
- Rituximab
Other Study ID Numbers
- CD-ON-MEDI-551-1019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Lymphocytic Leukemia (CLL)
-
AbbVieRecruitingCancer, Chronic Lymphocytic Leukemia (CLL)Korea, Republic of
-
Hackensack Meridian HealthCelgene CorporationTerminatedSmall Lymphocytic Lymphoma | Chronic Lymphocytic Leukemia(CLL)United States
-
Piramal Enterprises LimitedDana-Farber Cancer Institute; Norris Cotton Cancer CenterSuspendedRelapsed/Refractory Chronic Lymphocytic Leukemia (CLL)United States
-
Virginia Commonwealth UniversityGilead SciencesWithdrawnChronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | CLL | Refractory Small Lymphocytic Lymphoma | SLL | Relapsed CLL | Relapsed Chronic Lymphocytic Leukemia | Relapsed Small Lymphocytic Lymphoma
-
Tampere University HospitalCompleted
-
AstraZenecaRecruitingChronic Lymphocytic Leukaemia (CLL)Germany
-
University of California, IrvineUnited States Department of DefenseActive, not recruitingAcute Myeloid Leukemia | Chronic Lymphocytic Leukemia | AML, Adult | CLL | CLL, Relapsed | CLL, RefractoryUnited States
-
Memorial Sloan Kettering Cancer CenterPharmacyclics LLC.WithdrawnChronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | CLL | CLL/SLL | SLLUnited States
-
Novartis PharmaceuticalsCompletedChronic Lymphocytic Leukemia (CLL) | Leukaemia, Lymphocytic, ChronicUnited States, Belgium, Italy, Greece, Russian Federation, Spain, Poland, Czech Republic
-
AstraZenecaCLL ConsortiumCompletedB Cell Lymphomas | 11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL), | Prolymphocytic Leukaemia (PLL)United States
Clinical Trials on Rituximab
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingEBV-Related Post-Transplant Lymphoproliferative Disorder | Monomorphic Post-Transplant Lymphoproliferative Disorder | Polymorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Polymorphic Post-Transplant Lymphoproliferative... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent Small Lymphocytic Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Grade 3a Follicular... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAnn Arbor Stage I Grade 1 Follicular Lymphoma | Ann Arbor Stage I Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 1 Follicular Lymphoma | Ann Arbor Stage II Grade 2 Follicular LymphomaUnited States
-
National Cancer Institute (NCI)CompletedAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Recurrent Chronic Lymphocytic LeukemiaUnited States
-
PfizerCompletedRheumatoid ArthritisUnited States, Australia, Canada, Israel, Mexico, Colombia, Germany, Russian Federation, South Africa, United Kingdom
-
Mabion SAParexelWithdrawn
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
National Cancer Institute (NCI)Celgene CorporationActive, not recruitingAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaUnited States