A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies

Last updated: February 4, 2013
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Blood Cancer

Neoplasms

Hematologic Neoplasms

Treatment

N/A

Clinical Study ID

NCT01377116
D2850C00001
  • Ages > 20
  • Both

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any available standard line of therapy known to be life-prolonging or life-saving

  • Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonaltherapy for treatment of cancer

  • Previous therapy directed against CD19, such as monoclonal antibodies or MAbconjugates

Study Design

Total Participants: 18
Study Start date:
May 01, 2011
Estimated Completion Date:
February 28, 2014

Connect with a study center

  • Research site

    Nagoya-shi, Aichi
    Japan

    Active - Recruiting

  • Research site

    Isehara, Kanagawa
    Japan

    Active - Recruiting

  • Research site

    Fukuoka,
    Japan

    Active - Recruiting

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