Status:
COMPLETED
Cytotoxic T-Lymphocytes for the Prophylaxis of Cytomegalovirus After Allogeneic Stem Cell Transplant
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients have a type of blood cell cancer, other blood disease or a genetic disease for which they will receive a stem cell transplant. The donor of the stem cells will be either a brother or sister o...
Detailed Description
If the patient and their donor are eligible, we will take 100-120 ml (20-24 teaspoonfuls) of blood from the donor 3-4 weeks before the transplant. We will only take as much blood as is safe for the pa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Recipients of allogeneic donor stem cell transplants at risk for CMV reactivation with a CMV seropositive stem cell donor and at least 30 days post transplant.
- Recipients can have early evidence of CMV reactivation with greater than 2 leukocytes but less than 10 leukocytes positive for the CMV Ag per 100,000 cells.
- No evidence of graft-versus-host disease (GVHD) \> Grade II at time of enrollment.
- Life expectancy \> 30 days
- No severe intercurrent infections
- Lansky/Karnofsky scores greater than or equal to 60
- Absence of severe renal disease (Creatinine \> x 3 normal for age)
- Absence of severe hepatic disease (direct bilirubin \> 3 mg/dl or SGOT \> 500)
- Not receiving Ganciclovir, Foscarnet, or Cidofovir or other antiviral therapy for CMV reactivation
- Patient/guardian able to give informed consent
- Exclusion Criteria:
- Patients with CMV negative stem cell donors
- Patients with GVHD Grades III-IV
- Patients receiving antiviral therapy for CMV reactivation or other viral infections such as adenovirus or herpes viruses
- Patients with significant CMV reactivation. Significant CMV reactivation is defined as one CMV Antigenemia reading with \>10 leukocytes positive for the CMV Ag per 100,000 cells
- Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00078533
Start Date
April 1 2004
End Date
June 1 2011
Last Update
October 8 2014
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030