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Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE)

This study is currently recruiting participants.
Verified May 2013 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Julie-An M. Talano, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01535885
First received: February 6, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.


Condition Intervention Phase
Epstein-Barr Virus Infections
Adenovirus
Cytomegalovirus Infections
 Biological: Cytotoxic T Lymphocytes
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Study Of Using Multi-virus Cytotoxic T-cells Following T-cell Depleted Allogeneic Hematopoietic Progenitor Cell Transplantation For Prophylaxis Against Specific Pathogens- Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE TRIAL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • To assess toxicity by SAEs scored according to the adaptive CTCAE version 4 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evidence of immunity against specific viral pathogens- Ad, CMV and EBV in recipients of Multi-Virus CTLs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The incidence of Ad, EBV, and CMV systemic infections during the first 180 days post-transplant [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: February 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Cytotoxic T Lymphocytes
    Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-60 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used.
Detailed Description:

Within this clinical trial, the investigators will test the hypotheses that the administration of CTLs for prophylaxis against Ad, CMV and EBV in recipients of TCD-HPCT will be safe and well tolerated. Graded doses of Multi-Virus CTL will be administered to recipients of genotypically haploidentical (or 2 allele mismatched relative) or mismatched unrelated TCD grafts.

  Eligibility

Ages Eligible for Study:   up to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient age < 22 years.
  • Both genders and all races are eligible.
  • Undergoing a T-cell depleted allogeneic HPCT from a related HLA partially matched (two antigen mismatched, or haplodisparate) donor or a mismatched unrelated donor
  • Must be willing to sign a written informed consent.

  • Patient Organ Status at the time of enrollment (pre-transplant)

    • Lansky or Karnofsky score > 50
    • Echocardiogram shortening fraction > 27%
    • Renal function: serum creatinine < 2 x normal for age
    • DLCO > 50% predicted in patients old enough to comply with PFTs or no baseline oxygen requirement for younger patients.
    • Hepatic: AST, ALT < 5x upper limit of normal; bilirubin < 2.0 mg/dl
  • Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months following CTL infusion. The male partner should use a condom.
  • Patients must be between 28 and 60 days post T-cell depleted allogeneic HPCT

  • Patients must meet the following criteria (within 72 hours of CTL infusion):

    • Achieved primary engraftment with an ANC of at least 1000 per μl for 3 consecutive days.
    • No oxygen requirement with oxygen saturations > 90%.
    • AST, ALT < 5x upper limit of normal for age; bilirubin < 2 mg/dl.
    • Hemoglobin > 8 gm/dl prior to infusion. (May be transfusion dependent).
    • Renal function: serum creatinine < 2 x normal for age.

  • The Patient must not have the following conditions on the day of CTL infusion:

    • Exhibit overt hematologic manifestations of relapse or persistent disease.
    • Evidence of recurrent/persistent disease based primarily on flow cytometry, cytogenetics, chimerism analysis, or other molecular studies does not by itself represent grounds for exclusion.

Exclusion Criteria:

  • Currently enrolled on another Phase I clinical trial.
  • Pregnant or nursing
  • Overt hematologic manifestations of relapse or persistent disease
  • Having > grade 1 graft-versus-host disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535885

Contacts
Contact: Julie-An Talano, MD 414-955-4185 jtalano@mcw.edu
Contact: Kristine Allmendinger-Goertz, BA 414-266-2137 kallmend@mcw.edu

Locations
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Julie-An Talano, MD     414-955-4185        
Contact: Kristine Allmendinger-Goertz, BA     414-266-2137     kallmend@mcw.edu    
Principal Investigator: Julie-An Talano, MD            
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Julie-An Talano, MD Medical College of Wisconsin/Children's Hospital of Wisconsin
  More Information

No publications provided

Responsible Party: Julie-An M. Talano, Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01535885     History of Changes
Other Study ID Numbers: CTL-11/157
Study First Received: February 6, 2012
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:
Cytoxic T Lymphocytes(CTL)
T-cell Depleted
Allogeneic Transplant
Epstein Barr Virus
 Adenovirus
Cytomegalovirus
Hematopoietic progenitor cell transplantation

Additional relevant MeSH terms:
Adenoviridae Infections
Cytomegalovirus Infections
Virus Diseases
Epstein-Barr Virus Infections
DNA Virus Infections
 Herpesviridae Infections
Tumor Virus Infections
Neoplasms, Experimental
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013