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Houston, Texas 77030


Purpose:

The purpose of this study is to determine the largest and safest dose of Adenovirus (AdV)-specific cytotoxic T cells to be administered to individuals following a stem cell transplant, to evaluate the side effects of this treatment, and to examine whether this therapy might help prevent and treat AdV infection in these individuals.


Study summary:

Cell Administration: In this study, AdV-specific T cells will be thawed and intravenously injected into participants. This is a traditional, phase I dose escalation study of one infusion of AdV-specific cytotoxic T lymphocytes (AdV-CTL) given to participants at risk for AdV infection after either a matched or mismatched unrelated donor stem cell transplant OR a matched or mismatched related donor stem cell transplant. Four dose levels will be studied. The lowest level will be one dose of 5 x 10^6 cells/m2, and the highest will be one dose of 1.35 x 10^8 cells/m2. Two participants at each dose level will be enrolled (depending on toxicity), using the modified continual reassessment method (CRM). This approach was successfully used in optimizing the Epstein-Barr Virus (EBV) CTL infusion regimen. 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. Initially, AdV-CTL will be given at least 30 days following the transplant. If participants are diagnosed with AdV infection at their 30-day evaluation or at subsequent evaluations post-CTL, they will be eligible to receive one additional dose of CTL (at the same dose as the first CTL), provided that they meet the eligibility criteria described in the protocol. Dose Levels and Dosing Schedule: Dose Level and CTL Dose Given from Day 30 - Dose 1: 5 x 10^6/m2 - Dose 2: 1.5 x 10^7/m2 - Dose 3: 4.5 x 10^7/m2 - Dose 4: 1.35 x 10^8/m2 Escalation of AdV-CTL Infusions: Initially, AdV-CTL will be given 30 days following the transplant surgery. If participants are diagnosed with AdV infection (defined as culture positive from one site) at their 30-day evaluation or subsequent evaluations, they are eligible to receive one additional dose of CTL, given no less than 2 weeks apart, at the same dose of the first CTL, providing eligibility criteria are met. Infusion of CTL: Premedications: Participants will receive intravenously up to 1 mg/kg (up to a maximum of 50 mg) of Benadryl and 10 mg/kg (up to a maximum of 650 mg) of Tylenol prior to the injection of the cells. Cell Administration: AdV-specific T cells will be thawed and intravenously injected 30 days following the transplant at the specified dose schedule.


Criteria:

Inclusion Criteria: - Recipient of an allogeneic donor stem cell transplant and at risk for AdV disease - Life expectancy greater than 30 days - No severe intercurrent infections - Lansky/Karnofsky scores greater than or equal to 60 - Must be at least 30 days post transplant to be eligible to receive CTL Exclusion Criteria: - Presence of graft-versus-host disease (GVHD), Grades III-IV - Severe kidney disease, with creatinine levels greater than 3 times the normal limit for age - Severe liver disease, with direct bilirubin levels greater than 3 mg/dl or SGOT levels greater than 500 IU/L - AdV disease prior to 30 days post transplant (i.e., the presence of two or more positive sites for AdV by polymerase chain reaction [PCR] or culture) - Less than 50% donor chimerism in either peripheral blood or bone marrow OR experiences relapse of original disease - Currently receiving Cidofovir - Received other viral-specific CTL (e.g., CMV-specific CTL or EBV-specific CTL) prophylactically within 4 weeks of receiving Adv-CTL


NCT ID:

NCT00111033


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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