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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01466153
First received: September 30, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in patients with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Drug: MEDI-551
Drug: Rituximab
Drug: Bendamustine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Study Day 720 ] [ Designated as safety issue: No ]
    Evaluation of the Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), in adult subjects with relapsed or refractory CLL treated with up to 6 cycles of MEDI-551 in combination with bendamustine versus rituximab in combination with bendamustine.


Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Study Day 345 ] [ Designated as safety issue: Yes ]
    The safety endpoints include Adverse Events (AEs), Serious Adverse Events (SAEs) occurring during the protocol-specified reporting period and changes in clinical laboratory evaluations, Electrocardiogram (ECGs), vital signs, and weight from baseline.

  • Acceptable dose [ Time Frame: Study Day 56 ] [ Designated as safety issue: Yes ]
    Determination of an acceptable dose of MEDI-551 in combination with bendamustine; Benefit/Risk Analysis of Safety and Efficacy to be determined

  • Anti-tumor Activity [ Time Frame: Study Day 720 ] [ Designated as safety issue: No ]
    Complete Response (CR) rate, Minimal Residual Disease (MRD) negative CR rate, Time to Response (TTR), Time to Progression (TTP), Progression Free Survival (PFS); Overall Survival (OS)

  • Immunogenicity (IM) [ Time Frame: Study Day 720 ] [ Designated as safety issue: Yes ]
    Number and percentage of subjects who develop detectable anti-drug antibodies

  • Pharmacokinetics (PK) [ Time Frame: Study Day 1, Study Day 8, Study Day 15, Study Day 22, Study Day 29, Study Day 57, Study Day 85, Study Day 113, Study Day 141, Study Day 169, Study Day 197, Stduy Day 227, Study Day 255 ] [ Designated as safety issue: No ]
    Area Under Curve (AUC), Maximum concentration (CMAX), half time (T1-half); clearance (CL).

  • Overall Survival [ Time Frame: Study Day 720 ] [ Designated as safety issue: No ]
    Time from randomization until death due to any cause. OS to be censored on last date known to be alive for subjects either alive at end of study or lost to follow-up.


Enrollment: 183
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-551 (dose level 1) + Bendamistine Drug: MEDI-551
MEDI-551 will be administered by Intravenous (IV) infusion. There will an initial cycle and up to 5 subsequent cycles.
Drug: Bendamustine
Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion).
Experimental: MEDI-551 (dose level 2) + Bendamustine Drug: MEDI-551
MEDI-551 will be administered by Intravenous (IV) infusion. There will an initial cycle and up to 5 subsequent cycles.
Drug: Bendamustine
Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion).
Active Comparator: Rituximab + Bendamustine Drug: Rituximab
Rituximab will be administered at 375 mg/m2 by IV infusion on Day 2 of Cycle 1 and then at 500 mg/m2 on Day 1 of up to 5 subsequent 28-day cycles (90-minute infusion).
Other Name: Rituxan; MabThera
Drug: Bendamustine
Bendamustine will be administered to subjects in each treatment group at 70 mg/m2 by IV infusion on Days 1 and 2 of each 28-day cycle (30-min infusion).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466153

  Show 54 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Trishna Goswami, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01466153     History of Changes
Other Study ID Numbers: CD-ON-MEDI-551-1019
Study First Received: September 30, 2011
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada

Keywords provided by MedImmune LLC:
Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Bendamustine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014