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Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

This study has been terminated.
(After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.)
Information provided by:
MedImmune LLC Identifier:
First received: March 11, 2005
Last updated: June 12, 2007
Last verified: June 2007

March 11, 2005
June 12, 2007
February 2005
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  • To determine the maximum tolerated dose (MTD) or the optimal biological dose
  • (OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
  • CD-2 positive lymphoproliferative disorders.
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Complete list of historical versions of study NCT00105313 on Archive Site
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Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia

For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.

For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.

Not Provided
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Leukemia
  • Cancer
Drug: MEDI-507
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Individuals may be eligible for this study if they are 18 years of age or older and:

  • Have one of the following types of T-Cell Lymphoproliferative disorders such as Cutaneous T-cell Lymphoma (CTCL), Peripheral T-cell Lymphoma (PCTL), Large Cell Lymphoma (LGL), or Adult T-cell Lymphoma (ATL). Patients should have disease that is resistant or refractory to the front-line therapy, except ATL patients for whom there is no standard therapy.
  • At least 30% of tumor cells must be CD2 positive.
  • Karnofsky Performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work).
  • At least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first MEDI-507 administration (except thrombocytopenia).
  • Have no prior treatment with MEDI-507.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
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MedImmune LLC
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Study Director: Luz Hammershaimb, MD MedImmune LLC
MedImmune LLC
June 2007

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