NCT02479698 Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus
| NCT ID | NCT02479698 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Acquired Immunodeficiency Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2015-07-23 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2015-07-23 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.
Eligibility Criteria
Inclusion Criteria: * Patients ≥ 2 years. * English and non-English speaking patients are eligible. * Immunocompromised patients including but not limited to those with any type of malignancy, HIV/AIDS, or history of solid organ transplant * Non-immunocompromised patients with PML/JC virus encephalitis * Microscopic or greater hematuria urine or blood PCR positive for BK virus * Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and/or polyomavirus. * Definite or probable PML/JC viral encephalitis (see Appendix C) * JC end-organ disease * Receiving \> 6 mg / day of prednisone or equivalent at the time of enrollment. * Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion. * Patients with JCV encephalitis / PML may be receiving pembrolizumab. * Written informed consent and/or signed assent from patient, parent or guardian. * Patients with cognitive impairments are eligible. * A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for \< 1 year, and not having undergone surgical sterilization. * Women of childbearing potential must be willing to use an effective contraceptive measure while on study. * Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI. * Patients with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. * Patients with fungal infections patients must be receiving definitive systemic anti fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. * Patients may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment. Exclusion Criteria: * Patients receiving \> 6 mg / day of prednisone or equivalent at time of * Patients who have received ATG within 14 days of enrollment * Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment. * Patients who have received alemtuzumab within 28 days of enrollment. * Patients with other uncontrolled infections (including HIV/AIDS). Uncontrolled infection is defined as the presence of 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 uncontrolled infection. * Patients with active acute GVHD grades II-IV.
Contact & Investigator
George Chen, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT02479698 clinical trial?
This trial is open to participants of all sexes, studying Acquired Immunodeficiency Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02479698 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02479698 currently recruiting?
Yes, NCT02479698 is actively recruiting participants. Contact the research team at GLChen1@mdanderson.org for enrollment information.
Where is the NCT02479698 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT02479698 clinical trial?
NCT02479698 is sponsored by M.D. Anderson Cancer Center. The principal investigator is George Chen, MD at M.D. Anderson Cancer Center. The trial plans to enroll 100 participants.