Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation (NCT02210065) | Clinical Trial Compass
CompletedPhase 2
Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation
United States6 participantsStarted 2015-03-03
Plain-language summary
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem cell transplant. Researchers also want to learn about the safety of giving CTLs to patients who have had a stem cell transplant.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. STEP 1: Within 30 days of study entry: Patients with a history of bone marrow disorders including hematological malignancies and aplastic anemia, Myelodysplastic Syndrome (MDS) and Myeloproliferative disorder (MPD) planning to undergo allogeneic HSCT with reduced intensity or myeloablative conditioning regimens.
✓. Disease status must be complete remission by standard criteria for Lymphoma and Acute Leukemia patients.
✓. Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD) must have \<5% blasts in the bone marrow.
✓. Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow cytometry and molecular studies.
✓. Patients \>/= 18 years of age.
✓. Karnofsky greater than or equal to 80%.
✓. CMV seropositive.
✓. Donor is either matched related, matched unrelated, mismatched unrelated, or haploidentical. Cord blood recipients are also eligible.
Exclusion criteria
✕. STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.
✕. CMV seronegative.
✕. Positive for HIV, HBV, HCV, HTLV1 and/or HTLV2.
✕. STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): Documented CMV end-organ disease.
✕. Patients receiving ATG, or Campath within 28 days of CMV reactivation.
✕. Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to generating CTLs. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to generating CTLs. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
✕. Patients who have received donor lymphocyte infusion (DLI) within 28 days.
✕. Patients with active acute GVHD grades II-IV.