Clinical trial · Interventional
Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
A Phase I Trial to Examine the Safety, Clinical, Immunologic and Virologic Effects of CMV pp65 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistent 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: Vaccines may help the body build an effective immune response to kill cytomegalovirus infections. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who have undergone a donor stem cell transplant and have cytomegalovirus infection that has not responded to therapy.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytomegalovirus pp65-specific cytotoxic T lymphocytes | Biological | — | UNRESOLVED |
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm study
- interventionNames
- Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes
- Genetic: polymerase chain reaction
- Other: diagnostic laboratory biomarker analysis
- Other: flow cytometry
- Other: immunologic technique
Primary outcomes (3)
- measure
- Toxicity
- timeFrame
- 1 year
- measure
- Treatment failure
- timeFrame
- 1 year
- measure
- Safety
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Cytomegalovirus (CMV) seropositive * Patient has had CMV antigenemia for ≥ 2 weeks OR CMV DNA levels ≥ 600 copies/μg of DNA despite antiviral therapy targeting CMV (ganciclovir or foscarnet) * No prior allogeneic stem cell transplantation before the most recent transplantation * CMV seropositive donor negative for HIV-1, HIV-2, HTLV-1/2 available PATIENT CHARACTERISTICS: * ECOG performance status 0-2 (for patients ≤ 16 years of age) OR Lansky performance status 70-100% * Bilirubin \< 2.0 mg/dL * AST and ALT \< 2.5 times upper limit of normal * Creatinine clearance \> 50 mL/min * Pulse oximetry \> 95% without supplemental oxygen * No history of graft-vs-host disease (GVHD) ≥ grade 2 * Not moribund * No patients not expected to survive 1 month after T cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction PRIOR CONCURRENT THERAPY: * No concurrent systemic immunosuppressive agents for the treatment of GVHD
References
Publications (0)
Data not yet available