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An Investigator Initiated Open-label and Explorative Study of Alefacept Treatment for Chronic Extensive Graft Versus Host Disease


Phase 1/Phase 2
N/A
70 Years
Open (Enrolling)
Both
Resistant Chronic GVHD

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Trial Information

An Investigator Initiated Open-label and Explorative Study of Alefacept Treatment for Chronic Extensive Graft Versus Host Disease


Inclusion Criteria:



- No age limit

- Resistant chronic GVHD

Exclusion Criteria:

- Not fulfilling any of the inclusion criteria

- Active life-threatening infection

- Inability to comply with study requirements.

- Known hypersensitivity to alefacept.

- Active malignant disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

GVHD response.

Outcome Time Frame:

6m

Safety Issue:

No

Principal Investigator

Michael Y Shapira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Stem cell Transplantation & Cancer immunotherapy; Cell Therapy & Transplantation Biology Research Laboratory, Hadassah University Hospital

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

MYS-05-HMO-CTIL

NCT ID:

NCT00397332

Start Date:

October 2006

Completion Date:

July 2013

Related Keywords:

  • Resistant Chronic GVHD
  • GVHD
  • Graft vs Host Disease

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