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CLINICAL TRIAL FOR THE PREVENTION OF CYTOMEGALOVIRUS INFECTION IN HEMATOPOIETIC STEM CELL TRANSPLANTATION IN PATIENTS WITH NO AVAILABLE TREATMENT
EU CTIS ID: 2024-520020-28-00
What this study is testing
To evaluate the efficacy of antiviral prophylaxis with specific CTLs against CMV in reducing the incidence of CMV infection at 100 days posttransplant, according to historical controls of the haematology service of the Hospital Universitario Marqués de Valdecilla
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (over 18 years of age), whether or not diagnosed with hematologic malignancy, who have received an allogeneic HSCT hematopoietic progenitor transplant from HLA-identical family donors
- b. The donor will be screened to determine suitability according to the HSCT hematopoietic progenitor donor evaluation criteria
- C. The donor has to also sign a written informed consent prior to inclusion
- Non-candidates to receive Letermovir
- Source of HSC progenitors: peripheral blood or bone marrow
- Patients whose donor is CMV seropositive
You likely can't join if
- MUST NOT MEET ANY OF THE ESTABLISHED CRITERIA for the prescription of LETERMOVIR in CMV seropositive adult recipients of an allogeneic HSCT:
- ECOG > or = 3
- Organ toxicity greater than grade 3 according to CTCAE Version 5.0
- Uncontrolled infection, defined by fever and/or hemodynamic instability and/or unresolved infectious focus.
- Persistent fever (>38ºC) in the 3 days prior to the infusion
- Relapse or active and uncontrolled progression of the malignant disease
See the full eligibility criteria
- Adult patients (over 18 years of age), whether or not diagnosed with hematologic malignancy, who have received an allogeneic HSCT hematopoietic progenitor transplant from HLA-identical family donors
- b. The donor will be screened to determine suitability according to the HSCT hematopoietic progenitor donor evaluation criteria
- C. The donor has to also sign a written informed consent prior to inclusion
- Non-candidates to receive Letermovir
- Source of HSC progenitors: peripheral blood or bone marrow
- Patients whose donor is CMV seropositive
- Negative pregnancy test in women
- Written informed consent signed by the patient or legal representative
- Partial recovery of the hematopoietic implant (absolute neutrophil count >0.5 x10^9 cells/L for at least 3 consecutive post-HSCT determinations)
- Specific inclusion criteria for donors:
- a. Donors will be selected if they meet HLA identity criteria and are CMV seropositive
- MUST NOT MEET ANY OF THE ESTABLISHED CRITERIA for the prescription of LETERMOVIR in CMV seropositive adult recipients of an allogeneic HSCT:
- ECOG > or = 3
- Organ toxicity greater than grade 3 according to CTCAE Version 5.0
- Uncontrolled infection, defined by fever and/or hemodynamic instability and/or unresolved infectious focus.
- Persistent fever (>38ºC) in the 3 days prior to the infusion
- Relapse or active and uncontrolled progression of the malignant disease
- CMV viral reactivation prior to the day of infusion (21 post-HSCT) requiring anti-viral treatment (more than 200 copies of CMV by PCR in 2 determinations or more than 1000 in 1 determination).
- Previous therapy with Letermovir
- Specific exclusion criteria for donors:
- a. Active infection at the time of lymphoapheresis
- Related donor with at least one mismatch at one of the HLA locus (HLA-A, -B or -DR)
- Haploidentical donor
- Unrelated donor with at least one mismatch at one of the four HLA gene loci (HLA-A, -B, -C and -DRB1)
- Use of cord blood
- Use of graft with ex vivo T-lymphocyte depletion
- GvHD grade 2 or higher requiring the use of systemic corticosteroids (doses ≥1mg/kg/day of prednisone or equivalent doses of other corticosteroids
- AND MUST NOT MEET ANY OF THE CRITERIA BELOW to participate in the study:
- Treatment at the time of cell infusion with corticosteroid doses greater than 0.5mg/kg/day of prednisone or equivalents
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.