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

NCT02210078 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2013-0657NCI-2014-01990
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Solid Neoplasm; Cytomegaloviral Infection; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• Success, defined as R1 and R2 without treatment failure

  The best outcome is defined as R1 = in complete response (CR) for 4 consecutive weeks, starting at week 2, without the need for a second cytotoxic T-lymphocyte (CTL) infusion. The second best outcome is defined as R2 = not in CR at week 2, 3, or 4, but in CR or partial response (PR) 4 weeks after the second CTL infusion.

  Up to 4 weeks after second CTL infusion

Secondary Outcomes (4)

• Overall survival time

  Up to 12 months

• Disease-free survival time

  Up to 12 months

• Graft-versus-host disease

  Up to 12 months

• Secondary graft failure

  Up to 12 months

Study Arms (1)

Treatment (allogeneic CMV-specific cytotoxic T-lymphocytes)

EXPERIMENTAL

Patients receive allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes IV. Patients with partial response, stable disease, or progressive disease may receive an additional dose of allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes at a minimum of 2 weeks from the first infusion.

Biological: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes

Interventions

Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes BIOLOGICAL

Given IV

Treatment (allogeneic CMV-specific cytotoxic T-lymphocytes)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Cytomegalovirus Infections; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Betul Oran

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: February 19, 2015
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)