CMV viral infection in an immunocompromised host MedDRA version: 20.0 Level: LLT Classification code 10021819 Term: Infection in marrow transplant recipients System Organ Class: 100000004862
Conditions
Interventions
Product Name: ViroTCell
Product Code: ViroTCell
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not available
Current Sponsor code: ViroTCell
Other descriptive name: virus-specific
Sponsors
Banc de Sang i Teixits
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure 2. Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases a) Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment b) Patient with CMV reactivation and no organic disease, resistant or intolerant to 2 previous antiviral treatment lines (ganciclovir/valganciclovir and foscarnet) or not candidate to be treated due to not acceptable expected toxicity (severe renal insufficiency, neutropenia or severe thrombopenia) It is agreed that the patient is affected with a resistant CMV infection if the CMV copies doesn’t decrease in > 1 log in total blood or otherwise the absolute number of copies > 1x10E4/mL in total blood after 2 weeks of antiviral treatment. c) Patients with reactivation of recurrent CMV despite correct anti-CMV treatment. It will be considered a recurrent CMV infection if the patient has> 2 reactivations in a period 30 days 5. Signature of the informed consent form Are the trial subjects under 18? yes Number of subjects for this age range: 9 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1.Acute GVHD = grade II or chronic = moderate 2.Corticosteroid = 0.5mg/kg regardless the indication 3.Disease relapse at the time of infection or at any time after the Allogeneic transplant. 4.Severe renal disease (creatinine > 3gr/dL) 5.Severe hepatic disease (bilirrubine >3mg/dL or AST >500 U/L) except if it is secondary to the viral infection. 6.Having received a donor lymphocytes infusion or any cell therapy product within 60 days prior to inclusion in the study (with the exception of transfusions), or having it planned within the next 60 days. 7.Alteration of the general condition, infection or clinical or hemodynamic instability that, in the opinion of the researcher, does not recommend the use of T cells 8.Known hypersensitivity to murine proteins or iron dextran. 9.Positive serology to HIV, HBV (HBsAg, HBcAc), HCV and/or syphilis 10.Pregnant, lactating or women without adequate contraception (*) 11.Participation in a clinical trial with investigational medicinal products the last 30 days (*) The effective contraceptive methods contemplated in the protocol are the hormonal ones, intrauterine device (IUD), barrier methods, voluntary sterilization or females with menopause > 1 year of duration. The criteria should be reviewed once the donor has been selected and before proceeding to the donor's lymphoapheresis to confirm that the patient is still a candidate for treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the safety of ViroTCell administration to the recipient in the post-transplant period;Secondary Objective: 1-Efficacy of the ViroTCell infusion for the treatment of infection assessed by Viral Load (PCR) and Clinical assessment 2-Immune reconstitution ability aginst virus 3-Persistence studies of virus-specific T cells using chimerism techniques 4-Time elapsed until a donor is identified;Primary end point(s): -Safety assessment through physical examination, vital signs, laboratory data and adverse events. The development of acute GVHD will be measured by the Seattle modified criteria;Timepoint(s) of evaluation of this end point: +7, +14, +21, +28, +45, +60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -PCR quantitative viral load for CMV at +7, +14, +21, +28, +45, +60 days -Immune reconstitution against CMV using Elispot at +7, +14, +28, +60 days -Immune reconstitution against CMV by flow cytometry at +7, +14, +28, +60 days -T-cell persistence by chimerism: detection of donor cellularity (administered product) in the receptor serum at +14 y +28 days -Time elapsed in identifying the donor. The type of donor available at the time of patient’s inclusion, the type of donor finally selected and the time elapsed from the inclusion of the patient to the date of selection of the donor (date of the stimulation test of the selected donor).;Timepoint(s) of evaluation of this end point: +7, +14, +21, +28, +45, +60 days | — |
Countries
Spain
Contacts
Public ContactResearch and Education
Banc de Sang i Teixits
Outcome results
None listed