Clinical trial NCT01466153: A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Objective Response Rate
timeFrame: 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 outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: From time of consent to 90 days post last dose
measure: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs
timeFrame: From time of consent to 90 days post last dose
measure: Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs
timeFrame: From time of consent to 90 days post last dose
measure: Complete Response Rate
timeFrame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
measure: Minimal Residual Disease Negative Complete Response (CR) Rate
timeFrame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
measure: Time to Response
timeFrame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
measure: Time to Disease Progression (TTP)
timeFrame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
measure: Progression Free Survival (PFS)
timeFrame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
measure: Overall Survival (OS)
timeFrame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
measure: Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA)
timeFrame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)
measure: Terminal Half Life (t1/2) of MEDI-551
timeFrame: Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Burbank
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Skokie
country: United States
facility: Research Site
state: Illinois
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Newark
country: United States
facility: Research Site
state: Ohio
city: Watertown
country: United States
facility: Research Site
state: South Dakota
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Antwerpen
country: Belgium
facility: Research Site
city: Arlon
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Mons
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Amiens
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Libourne Cedex
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Wuerzburg
country: Germany
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Ramat Gan
country: Israel
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Meldola
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Rimini
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: San Giovanni Rotondo
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: MedImmune
role: STUDY_DIRECTOR
References: