Donor Cytomegalovirus-Specific Cytotoxic T-Lymphocytes in Treating Patients With a Persistent Cytomegalovirus Infection

Running, not enrolling · Phase 2

Conditions studied: Cytomegaloviral Infection, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

This phase II trial studies how well donor cytomegalovirus-specific cytotoxic T-lymphocytes work in treating patients with a cytomegalovirus infection that has come back or has not gotten better despite standard therapy. White blood cells from donors who have been exposed to cytomegalovirus may be effective in treating patients with a cytomegalovirus infection.

Key facts

Study ID

NCT02210078

Run by

M.D. Anderson Cancer Center

People needed

49

Starts

2015-02-19

Expected to finish

2027-08-31

Last updated by the study team

2026-08-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with or without a malignancy; and/or any type of autologous or allogeneic HSCT; and/or patients who are immunocompromised with CMV infection will be included.
• Persistent CMV infection despite optimum anti-viral therapy
• Patients with CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in bronchoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates OR
• Failure of antiviral therapy: defined as the continued presence of DNAemia (defined as >/= 137 copies/ml by PCR) for at least 2 weeks of CMV antiviral therapy OR
• Optimum therapy is defined as at least 14 days of therapy with Ganciclovir, Foscarnet, Cidofovir, or Valganciclovir for patients with disease or CMV viremia.
• Relapse while on CMV antiviral therapy defined as recurrence of DNAemia while being on at least 2 weeks of antiviral therapy OR
• Patients who cannot tolerate standard anti-viral therapy and cannot continue anti-viral treatment due to side effect profile will be eligible independent of anti-viral therapy duration.
• Clinical status at enrollment to allow tapering of steroids equal to or less than 0.5 mg/kg/day of prednisone.
• Patients with chronic GVHD if on prednisone equal to or less than 0.5 mg/kg and not receiving second-line GVHD treatments like Pentostatin, Infliximab, Etanercept, etc.
• Written informed consent and/or signed assent line from patient, parent or guardian.
• Written informed consent from patient or legally authorized representative (LAR). Patients with cognitive impairment are eligible.
• Negative pregnancy test in female patients of childbearing potential.
• Patients ≥ 2 years.
• English and non-English speaking patients are eligible.
• Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI.

You may not qualify if…

• Patients receiving prednisone >0.5 mg/kg/day at time of enrollment, or have received ATG, donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
• 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 enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. 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 with ongoing viral infections are excluded.
• Patients with active acute GVHD grades II-IV.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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