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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: April 12, 2013
Last verified: April 2013
History of Changes

September 22, 2009
April 12, 2013
June 2010
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00983619 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study Using MEDI-551 in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies
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

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).

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
B-cell Malignancies
Drug: MEDI-551
A humanized Immunoglobulin G (IgG)1 kappa monoclonal antibody (MAb) directed against human CD19.
  • Experimental: Dose Escalation: Cohort 1 (FL/MM)
    Subjects are dosed with 0.5mg/kg of active drug.
    Intervention: Drug: MEDI-551
  • Experimental: Dose Escalation: Cohort 2 (FL/MM)
    Subjects will be dosed with 1.0 mg/kg of active drug.
    Intervention: Drug: MEDI-551
  • Experimental: Dose Escalation: Cohort 3 (FL/MM/CLL/DLBCL)
    Subjects will be dosed with 2.0 mg/kg of active drug.
    Intervention: Drug: MEDI-551
  • 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.
    Intervention: Drug: MEDI-551
  • Experimental: Dose Escalation: Cohort 4 (FL/MM/CLL/DLBCL)
    Subjects will be dosed with 4.0 mg/kg of active drug.
    Intervention: Drug: MEDI-551
  • Experimental: Dose Escalation: Cohort 5 (FL/MM/CLL/DLBCL)
    Subjects will be dosed with 8.0 mg/kg of active drug.
    Intervention: Drug: MEDI-551
  • Experimental: Dose Escalation: Cohort 6 (FL/MM/CLL/DLBCL)
    Subjects will be dosed with 12.0 mg/kg of active drug.
    Intervention: Drug: MEDI-551
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Spain
 
NCT00983619
MI-CP204
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Trishna Goswami, M.D. MedImmune LLC
MedImmune LLC
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP