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An Investigator Initiated Double Blind Randomized Study of Alefacept Treatment Prevention of Graft Versus Host Disease in Myeloablative Stem Cell Transplantation


Phase 3
14 Years
75 Years
Open (Enrolling)
Both
Graft Versus Host Disease

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Trial Information

An Investigator Initiated Double Blind Randomized Study of Alefacept Treatment Prevention of Graft Versus Host Disease in Myeloablative Stem Cell Transplantation


Inclusion Criteria:



1. Patient age 14-75 years old with a disease necessitating allogeneic SCT.

2. In order to increase security, only full matched donors will be allowed and must be
willing and capable of donating peripheral blood stem cells preferably, or bone
marrow progenitor cells using conventional techniques, and lymphocytes if indicated.

3. Patients must sign written informed consents.

4. Patients must have an ECOG PS ≤ 2; creatinine < 2.0 mg/dl; ejection fraction > 40%;
DLCO > 50% of predicted; serum bilirubin < 3 gm/dl; elevated GPT or GOT > 3 x normal
values.

Exclusion Criteria:

1. Not fulfilling any of the inclusion criteria.

2. Active life-threatening infection.

3. Overt untreated infection.

4. Hypersensitivity to alefacept.

5. HIV seropositivity, Hepatitis B or C antigen positivity with active hepatitis.

6. Pregnant or lactating women.

7. Donor contraindication (HIV seropositive confirmed by western blot).

8. Hepatitis B antigenemia.

9. Evidence of bone marrow disease.

10. Unable to donate bone marrow or peripheral blood due to concurrent medical condition.

11. Inability to comply with study requirements.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Outcome Measure:

Acute GVHD occurrence.

Outcome Time Frame:

100d

Safety Issue:

No

Principal Investigator

Michael Y Shapira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

MYS-01-HMO-CTIL

NCT ID:

NCT00361413

Start Date:

July 2006

Completion Date:

December 2013

Related Keywords:

  • Graft Versus Host Disease
  • Stem cell transplantation
  • GVHD
  • Graft Versus Host Disease
  • Graft vs Host Disease

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