At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 6 enrolled
Drug / intervention
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Pre-Emptive Use of Recipient-Derived Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation After Allogeneic Stem Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) for Leukemia and Lymphoma. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem cell transplant. Researchers also want to learn about the safety of giving CTLs to patients who have had a stem cell transplant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMiltenyi Biotec B.V. & Co. KG
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartMar 2015
Primary CompletionMay 2019
TodayJul 2026
First PostedAug 6, 2014
Enrollment StartMar 3, 2015
Primary CompletionMay 13, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.9 years ago
Interventions
Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)biological
CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.