A Clinical Study Using MEDI-551 in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00983619
First received: September 22, 2009
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in subjects with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).


Condition Intervention Phase
B-cell Malignancies
Drug: MEDI-551
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • To evaluate the MTD or OBD of MEDI-551 in subjects with relapsed or refractory advanced B-cell malignancies and to determine the preliminary safety profile in these populations. [ Time Frame: Study Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the efficacy of MEDI-551 in subjects with advanced B-cell malignancies, and to characterize the PK and effect on circulating lymphocyte populations and Ig levels, and the immunogenicity of MEDI-551. [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2010
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation: Cohort 1 (FL/MM)
Subjects are dosed with 0.5mg/kg of active drug.
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.
Experimental: Dose Escalation: Cohort 2 (FL/MM)
Subjects will be dosed with 1.0 mg/kg of active drug.
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.
Experimental: Dose Escalation: Cohort 3 (FL/MM/CLL/DLBCL)
Subjects will be dosed with 2.0 mg/kg of active drug.
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.
Experimental: Dose expansion (CLL/DLBCL/FL)
Subjects will be dosed based on the MTD identified in the Dose Escalation Phase (Cohorts 1-6) or OBD.
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.
Experimental: Dose Escalation: Cohort 4 (FL/MM/CLL/DLBCL)
Subjects will be dosed with 4.0 mg/kg of active drug.
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.
Experimental: Dose Escalation: Cohort 5 (FL/MM/CLL/DLBCL)
Subjects will be dosed with 8.0 mg/kg of active drug.
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.
Experimental: Dose Escalation: Cohort 6 (FL/MM/CLL/DLBCL)
Subjects will be dosed with 12.0 mg/kg of active drug.
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.

Detailed Description:

To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of MEDI-551 in subjects with relapsed or refractory advanced B-cell malignancies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed CLL, DLBCL, FL;
  • Karnofsky Performance Status ≥ 70;
  • Life expectancy of ≥ 12 weeks;
  • Prior radiation therapy provided exposure does not exceed an area of 25% of marrow space
  • Adequate hematological function
  • Adequate organ function

Exclusion Criteria:

  • Any available standard line of therapy known to be life-prolonging or life-saving;
  • No concurrent therapy or therapy within six weeks of first dose of MEDI-551 for treatment of cancer
  • Previous therapy directed against CD19
  • Vaccination (other than experimental cancer vaccine therapy) within 28 days prior to receiving the first dose of MEDI-551;
  • History of other invasive malignancy within 5 years except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured;
  • Active infection requiring treatment
  • Autologous stem cell transplantation within 4 months prior to study entry;
  • Allogeneic stem cell transplantation or any other organ transplant;
  • Ongoing ≥ Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria.
  • Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551;
  • Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551 (inhaled and topical corticosteroids are permitted);
  • Documented current central nervous system involvement by leukemia or lymphoma;
  • Pregnancy or lactation;
  • Clinically significant abnormality on ECG.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983619

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35233-2155
United States, California
Research Site
La Jolla, California, United States, 92037
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20007
United States, Florida
Research Site
Tampa, Florida, United States, 33612
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, West Virginia
Research Site
Morgantown, West Virginia, United States, 26502
Belgium
Research Site
Gent, Belgium
Research Site
Leuven, Belgium, 3000
Research Site
Yvoir, Belgium, 5530
Canada, Quebec
Research Site
Montreal, Quebec, Canada
France
Research Site
Pierre Benite Cedex, France
Italy
Research Site
Rozzano, Milano, Italy
Research Site
Ferrara, Italy
Research Site
Modena, Italy
Research Site
Pesaro, Italy
Spain
Research Site
Madrid, Spain
Research Site
Salamanca, Spain, 37007
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Trishna Goswami, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00983619     History of Changes
Other Study ID Numbers: MI-CP204
Study First Received: September 22, 2009
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Cancer

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014