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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 July 2016 by Julie-An M. Talano, Medical College of Wisconsin
Sponsor:
Medical College of Wisconsin
Information provided by (Responsible Party):
Julie-An M. Talano, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01535885
First received: February 6, 2012
Last updated: July 20, 2016
Last verified: July 2016
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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: | 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:
Further study details as provided by Julie-An M. Talano, Medical College of Wisconsin:
Primary Outcome Measures:
- To assess toxicity by SAEs scored according to the adaptive CTCAE version 4 [ Time Frame: 1 year ]
Secondary Outcome Measures:
- 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 ]
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Multi-Virus CTLs
The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study.
|
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.
|
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 mismatched unrelated TCD grafts.
Eligibility| Ages Eligible for Study: | up to 22 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
-
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
-
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535885
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535885
Contacts
| Contact: Julie-An Talano, MD | 414-266-6471 | jtalano@mcw.edu | |
| Contact: Shelly LeVeque | 414-266-6471 | mleveque@chw.org |
Locations
| 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 | |
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
| 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: | July 20, 2016 |
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 |
ClinicalTrials.gov processed this record on July 21, 2017