Clinical trial · Interventional
Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus. PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytomegalovirus IE-1-specific cytotoxic T lymphocytes | Biological | — | UNRESOLVED |
| cytomegalovirus pp65-specific cytotoxic T lymphocytes | Biological | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunological diagnostic method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety
- measure
- Toxicity
Secondary outcomes (4)
- measure
- Time to development of cytomegalovirus (CMV)-specific immune reconstitution
- measure
- CMV DNA levels
- measure
- Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)
- measure
- Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Recipient of an allogeneic stem cell transplantation * Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria: * Patient has a history of CMV antigenemia for ≥ 2 weeks * CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet) * No ongoing graft-vs-host disease * Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria: * CMV-seropositive donor (≥ 2 years of age) * CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients \< 16 years of age) * Bilirubin \< 2.0 mg/dL * AST and ALT \< 2.5 times normal * Creatinine clearance ≥ 30 mL/min * Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask * Not moribund * No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion
References
Publications (0)
Data not yet available