Status:
COMPLETED
Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Patients
Lead Sponsor:
Banc de Sang i Teixits
Collaborating Sponsors:
Vall d'Hebron Institute of Oncology
Hospital Universitario La Fe
Conditions:
CMV Viremia
Immunosuppression-related Infectious Disease
Eligibility:
All Genders
1+ years
Phase:
PHASE1
PHASE2
Brief Summary
Marrow transplanted immunocompromised patients with cytomegalovirus (CMV) viral infection will be treated with CMV activated T-Lymphocytes. T-Lymphocytes will be obtained through an apheresis from a c...
Detailed Description
A prospective, multicentre, open-label and uncontrolled phase Ib-II clinical trial in which a total of 20 patients ≥ 1 year of age with an allogeneic transplant of hematopoietic progenitors and post-t...
Eligibility Criteria
Inclusion
- 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
- 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
- Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment
- 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.
- 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 \<6 months despite having received correct anti-CMV treatment
- Documented genetic mutations associated with ganciclovir or foscarnet resistance
- ≥ 1 year of age
- Estimated life expectancy \> 30 days
- Signature of the informed consent form
Exclusion
- Acute graft-versus-host disease (GVHD) ≥ grade II or chronic ≥ moderate
- Corticosteroid ≥ 0.5mg/kg regardless the indication
- Disease relapse at the time of infection or at any time after the Allogeneic transplant.
- Severe renal disease (creatinine \> 3gr/dL)
- Severe hepatic disease (bilirubin \>3mg/dL or aspartate aminotransferase (AST) \>500 U/L) except if it is secondary to the viral infection.
- 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.
- 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
- Known hypersensitivity to murine proteins or iron dextran.
- Positive serology to human immunodeficiency virus (HIV), hepatitis B virus (HBV) (HBsAg, HBcAc), hepatitis C virus (HCV) and/or syphilis
- Pregnant, lactating or women without adequate contraception
- Participation in a clinical trial with investigational medicinal products the last 30 days
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04018261
Start Date
July 4 2019
End Date
October 18 2021
Last Update
January 24 2024
Active Locations (7)
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1
ICO Badalona
Badalona, Barcelona, Spain, 08916
2
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 08950
3
ICO l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025