A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT01466153
Last Updated: 2017-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2012-02-07
2016-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Bendamustine
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 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
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
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.
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
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
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.
Interventions
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Rituximab
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
Bendamustine
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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;
18 Years
99 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Burbank, California, United States
Research Site
La Jolla, California, United States
Research Site
Palm Springs, California, United States
Research Site
Skokie, Illinois, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
Fargo, North Dakota, United States
Research Site
Dayton, Ohio, United States
Research Site
Newark, Ohio, United States
Research Site
Watertown, South Dakota, United States
Research Site
Lubbock, Texas, United States
Research Site
Morgantown, West Virginia, United States
Research Site
Antwerp, , Belgium
Research Site
Arlon, , Belgium
Research Site
Kortrijk, , Belgium
Research Site
Mons, , Belgium
Research Site
Wilrijk, , Belgium
Research Site
Yvoir, , Belgium
Research Site
Toronto, Ontario, Canada
Research Site
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, , France
Research Site
Marseille, , France
Research Site
Nîmes, , France
Research Site
Dortmund, , Germany
Research Site
Essen, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
München, , Germany
Research Site
Würzburg, , Germany
Research Site
Haifa, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Bari, , Italy
Research Site
Lecce, , Italy
Research Site
Meldola, , Italy
Research Site
Milan, , 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
Warsaw, , Poland
Countries
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Other Identifiers
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CD-ON-MEDI-551-1019
Identifier Type: -
Identifier Source: org_study_id
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