Cytomegaloviral InfectionPhase 2NCT02210078
Donor Cytomegalovirus-Specific Cytotoxic T-Lymphocytes in Treating Patients With a Persistent Cytomegalovirus Infection
A Phase 2 study testing Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes in people with Cytomegaloviral Infection and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytomegaloviral Infection, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2015to 31 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Most Closely HLA Matched Allogeneic CMV Specific Cytotoxic T-Lymphocytes (CTL) to Treat CMV Infection After Hemapoietic Stem Cell Transplantation (HSCT)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched cytomegalovirus (CMV) specific cytotoxic T-lymphocytes (HMC-CTLs) generated by "gamma-catch" to mediate antiviral activity in hematopoietic stem cell transplantation (HSCT) recipients with CMV infections.
SECONDARY OBJECTIVE:
- To assess the persistency of the administered HMC-CTLs generated by "gamma-catch" and their contribution immune reconstitution.
OUTLINE:
Patients receive allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes intravenously (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.
After completion of study treatment, patients are followed up periodically for 12 months.
- Conditions
- Cytomegaloviral Infection, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- Being tested
- Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
- Medical subject headings
- Cytomegalovirus Infections, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytesBiological
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks after second CTL infusion
Secondary outcomes (4)
Overall survival time
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
Measured: Up to 12 months
Disease-free survival time
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
Measured: Up to 12 months
Graft-versus-host disease
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression.
Measured: Up to 12 months
Secondary graft failure
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study start19 Feb 2015
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegaloviral InfectionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Betul Oran, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210078
- Sponsor's protocol ID
- 2013-0657
- Other IDs
- NCI-2014-01990, 2013-0657
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2014
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No