A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

NCT01466153 | Completed Phase 2 Results DMC

• 1 other identifier: CD-ON-MEDI-551-1019
• Study Type: interventional
• Target: 183
• Locations: 8 countries
• Sites: 54

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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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 Outcomes (11)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)

  From time of consent to 90 days post last dose

• Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs

  From time of consent to 90 days post last dose

• Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs

  From time of consent to 90 days post last dose

• Complete Response Rate

  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

  From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)

Study Arms (3)

Rituximab + Bendamustine

ACTIVE COMPARATOR

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.

Drug: Rituximab; Drug: Bendamustine

MEDI-551 2 mg/kg + Bendamustine

EXPERIMENTAL

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.

Drug: Bendamustine; Drug: MEDI-551

MEDI-551 4 mg/kg + Bendamustine

EXPERIMENTAL

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.

Drug: Bendamustine; Drug: MEDI-551

Interventions

Rituximab DRUG

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

Also known as: Rituxan; MabThera

Rituximab + Bendamustine

Bendamustine DRUG

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 4 mg/kg + Bendamustine; Rituximab + Bendamustine

MEDI-551 DRUG

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 2 mg/kg + Bendamustine; MEDI-551 4 mg/kg + Bendamustine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (54)

Research Site

Birmingham, Alabama, United States

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Burbank, California, United States

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La Jolla, California, United States

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Palm Springs, California, United States

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Skokie, Illinois, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Fargo, North Dakota, United States

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Dayton, Ohio, United States

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Newark, Ohio, United States

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Watertown, South Dakota, United States

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Lubbock, Texas, United States

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Morgantown, West Virginia, United States

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Antwerp, Belgium

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Arlon, Belgium

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Kortrijk, Belgium

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Mons, Belgium

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Wilrijk, Belgium

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Yvoir, Belgium

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Amiens, France

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Bayonne, France

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Bordeaux, France

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Le Mans, France

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Libourne, France

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Marseille, France

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Nîmes, France

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Dortmund, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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München, Germany

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Würzburg, Germany

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Haifa, Israel

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Ramat Gan, Israel

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Bari, Italy

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Lecce, Italy

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Meldola, Italy

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Milan, Italy

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Modena, Italy

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Napoli, Italy

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Orbassano, Italy

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Palermo, Italy

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Pisa, Italy

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Ravenna, Italy

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Rimini, Italy

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Roma, Italy

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San Giovanni Rotondo, Italy

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Torino, Italy

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Udine, Italy

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Gdynia, Poland

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Warsaw, Poland

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MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Recurrence; Lymphoma, Non-Hodgkin

Interventions

Rituximab; Bendamustine Hydrochloride; inebilizumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazenca.com

1-877-240-9479

Study Officials

• MedImmune

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: November 7, 2011
• Study Start: February 7, 2012
• Primary Completion: January 8, 2016
• Study Completion: January 8, 2016
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-04

Locations

BE (6); IL (2); PL (2); FR (7); US (14); IT (15); DE (5); CA (3)