Donor CMV Specific CTLs in Treating CMV Reactivation or Infection in Participants Who Have Undergone Stem Cell Transplant or Solid Organ Transplant
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|ClinicalTrials.gov Identifier: NCT03665675|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allogeneic Hematopoietic Stem Cell Transplantation Recipient Cytomegalovirus Donor Solid Organ Transplantation Recipient||Biological: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes||Early Phase 1|
PRIMARY OBJECTIVE I. Assess the safety and feasibility of administering high-throughput antigen stimulation/interferon gamma capture system (Miltenyi Biotec, CliniMACS Prodigy System) generated CMV specific- CTLs from haploidentical donors in transplant patients both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT) with CMV infection despite standard therapy.
Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes intravenously (IV). Participants with partial response, may receive up to 2 additional doses at monthly intervals.
After completion of study treatment, participants are followed up at 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Haploidentical Donor Cytomegalovirus (CMV) Specific Cytotoxic T-Lymphocytes (CTL) to Treat CMV Reactivation or Infection After Solid Organ and Hematopoietic Stem Cell Transplantation (HCT)|
|Actual Study Start Date :||January 24, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Treatment (CMV-specific CTLs)
Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with partial response, may receive up to 2 additional doses at monthly intervals.
Biological: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
- Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: Up to 30 days post infusion ]Measured as the proportion of patients with acute (a) graft versus host disease (GvHD) grades III-IV or graft rejection/failure within 30 days of the last dose of cytotoxic T-lymphocytes (CTLs) or grades 3-5 infusion-related adverse events within 7 days of the last does of CTLs or grades 4-5 non-hematological adverse events within 30 days of the last dose of CTLs and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities. Will be calculated by dividing by all evaluable patients and the corresponding 95% confidence intervals will be calculated.
- Feasibility defined as identifying a suitable donor within 4 weeks and meeting minimum T cell doses in the final product [ Time Frame: Up to 1 year ]
- Antiviral activity defined as response to viral load [ Time Frame: At day 28 ]Complete response, partial response, stable disease or progression will be defined and proportion of each outcome will be calculated.
- Persistence of infused CTLs as measured by T cell gene rearrangement and effects on clinical signs of viral infection [ Time Frame: Up to 1 year ]
- Overall survival [ Time Frame: From last CTL infusion till death, assessed at 6 and 12 months ]Kaplan-Meier survival function will be used to estimate the survival probability.
- Risk for chronic GVHD [ Time Frame: At 6 and 12 months post CTL infusion ]Survival analysis method will be applied. Time to chronic GVHD will be defined from time of the last CTL infusion to the onset of chronic GVHD, or the last clinical assessment date if no chronic GVHD. Cumulative incidence of chronic GVHD at 6 and 12 months will be estimated.
- Systemic infections [ Time Frame: Within 6 months of CTL infusion ]Will be reported by etiologic agent, site of disease, date of onset, and severity.
- Secondary graft failure [ Time Frame: 30 days post-CTL infusion ]Proportion of secondary graft failure for both populations will be assessed at 30 days post CTL infusion will be calculated and 95% confidence intervals will be estimated accordingly.
- Effects of cytomegalovirus (CMV) specific-CTL on viral loads assessed by weekly reverse transcriptase-polymerase chain reaction [ Time Frame: Up to 1 year ]
- Viral reactivations [ Time Frame: Up to 6 months ]Proportion of viral reactivations within 6 months will be calculated and 95% confidence intervals will be estimated accordingly.
- Clinical response to CTL infusions [ Time Frame: At 6 weeks and 3 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665675
|Contact: The Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Nicole Szuminski||614-688-9796||Nicole.Szuminski@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Sumithira Vasu, MBBS 614-293-3196 Sumithira.Vasu@osumc.edu|
|Principal Investigator: Sumithira Vasu, MBBS|
|Principal Investigator:||Sumithira Vasu, MBBS||Ohio State University Comprehensive Cancer Center|