Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy (INMUNOCELL)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2026
  • participants needed
    15
  • sponsor
    Instituto de Investigación Marqués de Valdecilla
Updated on 27 May 2022

Summary

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.

Description

In HAPLO, CMV infection and disease are more frequent than in other type of HSCT, this is related to delayed immune reconstitution after transplant increasing post-transplant infectious complications. Approximately 60% of patients reactivated CMV infection after HAPLO and 15%, developed CMV disease afecting organs and causing the death of the patient in 8% of CMV disease cases.

If patient and donor are eligible, it will take 1x10^9 cells from donor leukapheresis. Donor cells will be selected and procesed by CliniMACs PRODIGY and after 12h it will obtain 7mL of CMV-CTLs. It will use 6mL of CMV-CTLs to infused a dose of 1x10^5 cells/kg in our patient. The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 21 (+- 7 days) days after transplant.

The CMV-DNA levels will be monitored weekly for at least 100 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then the patient will receive treatment with anti-CMV comercial drugs.

Details
Condition CMV
Treatment CMV CTLs
Clinical Study IdentifierNCT04056533
SponsorInstituto de Investigación Marqués de Valdecilla
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO)
Any source of stem cells (peripheral blood or bone marrow)
CMV-seropositive donors
Negative pregnancy test in women
Signed writen informed consent
DONORS
HLA haploidentical and CMV-seropositve donors
Donor must be checked and suitable
Signed writen informed consent
Donor without active infection evidence at leukapheresis

Exclusion Criteria

Patients without haploidentical CMV-seropositive donors
Patients who are not suitable for follow up visits
CMV-CTLs Infusion Criteria
Hematopoiesis recovery at least partial (neutrophil counts >0.5x10^9/L in at least 3 consecutive samples post-transplant)
CMV-CTLs NON-Infusion Criteria
Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion
ECOG > or = 3
Organic toxicities grade > or = 3
Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion
Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved
Persistent fevers 3 days before infusion
Acute Graft Versus Host Disease (GVHD) grade II-IV
Relapse or progression after transplant and before infusion day
CMV reactivation/infection after transplant and before infusion day
Patients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered
screening failures and will be out of the study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note