Status:
COMPLETED
Safety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Cytomegalovirus Infection
Adenovirus Infection
Eligibility:
All Genders
Up to 90 years
Phase:
PHASE1
Brief Summary
With this study, we want to see if we can use a kind of white blood cell called T cells to prevent or treat AdV and CMV infection. We will grow these T cells from the cord blood before the patients tr...
Detailed Description
We plan to grow T cells from the cord blood in the laboratory in a special way, to see if they can help prevent or treat infections in transplant patients with these viruses. This therapy with special...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Inclusion criteria at the time of Procurement:
- Patient with malignant or nonmalignant diseases who are candidates for transplant.
- Patients must have a single CB unit matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The unit must be cryopreserved in two fractions, with a minimum of 2.5x10\^7 total nucleated cells per kg pre-thaw in the fraction which will be used for the primary transplant. The remaining fraction will be used to generate the CTLs to give at day 30 or beyond as described below.
- Inclusion criteria at the time of CTL infusion:
- Recipients of a single cord blood unit fractionated into 2 fractions (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral disease or reactivation.
- Lansky/Karnofsky scores 60 or greater
- Absolute neutrophil count (ANC) greater than 500/ul.
- No evidence of GVHD \> Grade II at time of enrollment.
- Life expectancy \> 30 days
- Absence of severe renal disease (Creatinine \> x 3 normal for age)
- Absence of severe hepatic disease. Direct bilirubin must be less than 3 mg/dl and AST less than 5x upper limit of normal
- Patient must be at least 30 days post transplant to be eligible to receive CTL
- Written informed consent and/or signed assent line from patient, parent or guardian.
- Patient not on Fi02 of \>60%
- EXCLUSION CRITERIA:
- Exclusion criteria at the time of Procurement:
- Pregnant or Lactating
- Patients with active central nervous system disease
- Patients with Karnofsky performance status \<70%
- Patients with grade 3 or 4 or primary myelofibrosis
- Patients with suitable related donors
- Exclusion criteria at the time of CTL infusion:
- Pregnant or lactating
- Unable to wean steroids to 0.5 mg/kg/day or less prednisone.
- Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia in absence of PTLD). For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- 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 :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00880789
Start Date
May 1 2009
End Date
June 1 2014
Last Update
October 15 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