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Virus-Specific Cytotoxic T-Lymphocytes (CTLs) for Adenovirus Infection Post Allogeneic Stem Cell Transplant - Article


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CF Gene Mutation


Clinical Trial: Virus-Specific Cytotoxic T-Lymphocytes (CTLs) for Adenovirus Infection Post Allogeneic Stem Cell Transplant

This study is currently recruiting patients.

Sponsors and Collaborators: Baylor College of Medicine
Texas Children's Hospital
Information provided by: Baylor College of Medicine

Purpose

The purpose of this study is to find the largest safe dose of Adenovirus (AdV) specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help prevent and treat AdV infection after transplant.

Condition Treatment or Intervention Phase
Adenovirus Infection
 Gene Transfer: CMV (cytomegalovirus)-specific CTL
 Gene Transfer: EBV (Epstein-Barr Virus)-specific CTL
Phase I

MedlinePlus related topics:  Viral Infections

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Administration of Virus-Specific Cytotoxic T-Lymphocytes for the Prophylaxis and Therapy of Adenovirus Infection Post Allogeneic Stem Cell Transplant

Further Study Details: 

Expected Total Enrollment:  20

Study start: September 2003

Cell administration will be as follows: Adenovirus specific T cells will be thawed and given by intravenous injection. This is a traditional Phase I dose escalation study of one infusion of Adenovirus-specific CTLs given to patients at risk for Adenoviral infection after matched or mismatched unrelated or matched or mismatched related donor stem cell transplant.

Three dose levels will be explored. The lowest level will be 1x dose of 1x10e7cells/m2 and the highest will be 1x dose of 1x10e8/m2. Three to six patients will be entered at each dose level (depending on toxicity) following the scheme below. This approach was successfully used in optimizing our EBV CTL infusion regime. If there are no toxicities and immunological efficacy is not seen at any dose, then the doses will be further escalated after additional local and federal approval. If the patient has Adenoviral infection, they will be eligible to receive one additional injection of CTL at the original dose.

Dose Levels and Dosing Schedule: Dose Level and CTL Dose Given from Day 30

Dose 1: 1 x 10e7/m2

Dose 2: 5 x 10e7/m2

Dose 3: 1 x 10e8/m2

Initially, Adenoviral specific Cytotoxic T Lymphocytes (AdV-CTL) will be given from day +30.

If patients develop Adenoviral infection from their 30 day or subsequent evaluations, they are eligible to receive one additional dose of CTLs.

Infusion of CTL Premedications: Patients will be premedicated with Benadryl 1mg/kg (max 50 mg) intravenously (IV) and Tylenol 10 mg/kg (max 650 mg) by mouth (PO).

Cell Administration: AdV-specific T cells will be thawed and given by intravenous injection initially from day 30 post transplant at the dose schedule outlined under Cell Administration.

Eligibility

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Recipients of allogeneic donor stem cell transplants at risk for Adenoviral disease.
  • No evidence of 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)
  • Patient must be at least 30 days post transplant to be eligible to receive CTL.
  • Not receiving Cidofovir
  • Have not received other viral-specific CTL prophylactically within 4 weeks of receiving Adv-CTL.
  • Patient/guardian able to give informed consent

Exclusion Criteria:

  • Patients with GVHD Grades III-IV
  • Patients with hepatic or renal disease as specified above
  • Patients who have received other viral-specific CTL (e.g. CMV-specific CTL or EBV-specific CTL) prophylactically within 4 weeks of receiving Adv-CTL.
  • Patients with Adenoviral disease prior to day +30 post transplant. Adenoviral disease is defined as the presence of two or more sites positive for adenovirus by PCR or culture
  • Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00111033

Catherine M Bollard, MD      832-824-4781    cmbollar@texaschildrenshopsital.org

Texas
      Texas Children's Hospital, Houston,  Texas,  77030,  United States; Recruiting
Catherine M Bollard, MD  832-824-4781    cmbollar@texaschildrenshopsital.org 

Study chairs or principal investigators

Malcolm K Brenner, MD,  Study Chair,  Baylor College of Medicine   

More Information

Study ID Numbers:  14097; LYPTAIST
Record last reviewed:  May 2005
Last Updated:  May 16, 2005
Record first received:  May 16, 2005
ClinicalTrials.gov Identifier:  NCT00111033
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17


Source: ClinicalTrials.gov
Cache Date: May 18, 2005


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Page Updated: June 1, 2005
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