A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Phase 1
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Blood Cancer, Advanced B Cell Malignancies
Both
Blood Cancer, Advanced B Cell Malignancies
Trial Information
A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Inclusion Criteria:
- Japanese men or women at least 20 years of age
- Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL,
or MM.
- Karnofsky Performance Status ≥70;
- Life expectancy of ≥12 weeks
Exclusion Criteria:
- Any available standard line of therapy known to be life-prolonging or life-saving
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal
therapy for treatment of cancer
- Previous therapy directed against CD19, such as monoclonal antibodies or MAb
conjugates
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients with Adverse Events
Outcome Time Frame:
From baseline to 30 days after the last dose of study drug
Safety Issue:
Yes
Principal Investigator
Ramy Ibrahim
Investigator Role:
Study Director
Investigator Affiliation:
MedImmune LLC
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D2850C00001
NCT ID:
NCT01377116
Start Date:
May 2011
Completion Date:
February 2014
Related Keywords:
- Blood Cancer
- Advanced B Cell Malignancies
- Phase I
- advanced
- B cell malignancies
- dose escalation
- CD19
- Japanese
- Neoplasms
- Hematologic Neoplasms
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