Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against Epstein Barr Virus, Adenovirus, And Cytomegalovirus (ACE)
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ClinicalTrials.gov Identifier: NCT01535885 |
Recruitment Status
:
Recruiting
First Posted
: February 20, 2012
Last Update Posted
: August 14, 2017
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Condition or disease | Intervention/treatment | Phase |
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Epstein-Barr Virus Infections Adenovirus Cytomegalovirus Infections | Biological: Cytotoxic T Lymphocytes | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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) |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | February 2019 |
Estimated Study Completion Date : | February 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Multi-Virus CTLs
The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study.
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Biological: Cytotoxic T Lymphocytes
Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 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.
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- To assess toxicity by SAEs scored according to the adaptive CTCAE version 4 [ Time Frame: 1 year ]
- Evidence of immunity against specific viral pathogens- Ad, CMV and EBV in recipients of Multi-Virus CTLs [ Time Frame: 1 year ]
- The incidence of Ad, EBV, and CMV systemic infections during the first 180 days post-transplant [ Time Frame: 1 year ]

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Ages Eligible for Study: | up to 22 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient age < 22 years.
- Both genders and all races are eligible.
- The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled.
- Must be willing to sign a written informed consent.
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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 100 days post T-cell depleted allogeneic HPCT
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535885
Contact: Julie-An Talano, MD | 414-266-6471 | jtalano@mcw.edu | |
Contact: Shelly LeVeque | 414-266-6471 | mleveque@chw.org |
United States, Wisconsin | |
Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Julie-An Talano, MD 414-266-6471 | |
Contact: Shelly LeVeque 414-266-6471 mleveque@chw.org | |
Principal Investigator: Julie-An Talano, MD |
Principal Investigator: | Julie-An Talano, MD | Medical College of Wisconsin/Children's Hospital of Wisconsin |
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 |
First Posted: | February 20, 2012 Key Record Dates |
Last Update Posted: | August 14, 2017 |
Last Verified: | August 2017 |
Keywords provided by Julie-An M. Talano, 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:
Infection Communicable Diseases Virus Diseases Adenoviridae Infections Cytomegalovirus Infections |
Epstein-Barr Virus Infections DNA Virus Infections Herpesviridae Infections Tumor Virus Infections |