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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)


Phase 1
N/A
22 Years
Open (Enrolling)
Both
Epstein-Barr Virus Infections, Adenovirus, Cytomegalovirus Infections

Thank you

Trial Information

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)


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To assess toxicity by SAEs scored according to the adaptive CTCAE version 4

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Julie-An Talano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin/Children's Hospital of Wisconsin

Authority:

United States: Food and Drug Administration

Study ID:

CTL-11/157

NCT ID:

NCT01535885

Start Date:

February 2012

Completion Date:

February 2017

Related Keywords:

  • Epstein-Barr Virus Infections
  • Adenovirus
  • Cytomegalovirus Infections
  • Cytoxic T Lymphocytes(CTL)
  • T-cell Depleted
  • Allogeneic Transplant
  • Epstein Barr Virus
  • Adenovirus
  • Cytomegalovirus
  • Hematopoietic progenitor cell transplantation
  • Adenoviridae Infections
  • Cytomegalovirus Infections
  • Virus Diseases
  • Epstein-Barr Virus Infections

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226