Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus
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|ClinicalTrials.gov Identifier: NCT02479698|
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : October 12, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome BK Virus Infection Human Immunodeficiency Virus JC Virus Infection Malignant Neoplasm Merkel Cell Carcinoma Merkel Cell Polyomavirus Infection Viral Encephalitis||Biological: Allogeneic BK-specific Cytotoxic T-lymphocytes Other: Laboratory Biomarker Analysis||Phase 2|
I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched BK specific cytotoxic T lymphocyte (CTL) lines (BK-CTLs) generated by ex vivo expansion to mediate antiviral activity in patients with any type of malignancies, and/or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDs), and/or history of solid organ transplant with BK and JC infections.
I. To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in patients with any type of malignancies, and/or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously (IV) over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 7 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.
After completion of study treatment, patients are followed up periodically for 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection|
|Actual Study Start Date :||July 23, 2015|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: Treatment (BK-specific cytotoxic T lymphocytes)
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes IV over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 19 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.
Biological: Allogeneic BK-specific Cytotoxic T-lymphocytes
Other: Laboratory Biomarker Analysis
- Response, defined as response (R) = (best response [R1] or second best response [R2]) [ Time Frame: Up to 56 days ]The method of Thall et al will be used to monitor the probabilities of response.
- Incidence of acute graft-versus-host disease (GVHD) [ Time Frame: Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs) ]The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD.
- Incidence of adverse events [ Time Frame: Up to day 100 ]Will be continuously monitored.
- Overall survival [ Time Frame: Up to 12 months ]Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
- Glomerular filtration rate [ Time Frame: Up to 12 months ]Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with any type of malignancies; and/or HIV/AIDs; and/or history of solid organ transplant; and/or Merkel polyoma-virus related Merkel cell tumor(s) with measurable disease on imaging per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood polymerase chain reaction (PCR) positive for BK virus and/or JC viral encephalitis
- Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone
- Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion
- Once patients have completed 6-week safety and efficacy assessments after completion of the last anti-BK CTL infusion, patients will be eligible for enrollment on other supportive care protocols
- Written informed consent from patient and/or signed assent from patient, parent or guardian
- Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
- Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment
- Patients with other uncontrolled infections (except HIV/AIDS); 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 active acute graft-versus-host disease (GVHD) grades II-IV
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): NCT02479698
|Contact: Amanda L. Olson, MD||713-792-8750||ALOlson@mdanderson.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Amanda Olson 713-792-8750|
|Principal Investigator: Amanda Olson|
|Principal Investigator:||Amanda Olson||M.D. Anderson Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2015-01264 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0279 ( Other Identifier: M D Anderson Cancer Center )
|First Posted:||June 24, 2015 Key Record Dates|
|Last Update Posted:||October 12, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Acquired Immunodeficiency Syndrome
Carcinoma, Merkel Cell
Immunologic Deficiency Syndromes
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases
Central Nervous System Diseases
Nervous System Diseases
DNA Virus Infections
Tumor Virus Infections
Neoplasms, Germ Cell and Embryonal