Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
This study is ongoing, but not recruiting participants.
Sponsor:
Milton S. Hershey Medical Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00769613
First received: October 8, 2008
Last updated: August 20, 2011
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Biological: cytomegalovirus IE-1-specific cytotoxic T lymphocytes Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes Biological: therapeutic allogeneic lymphocytes Genetic: polymerase chain reaction Other: flow cytometry Other: immunological diagnostic method Other: laboratory biomarker analysis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
neuroblastoma
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Cytomegalovirus Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Safety [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to development of cytomegalovirus (CMV)-specific immune reconstitution [ Designated as safety issue: No ]
- CMV DNA levels [ Designated as safety issue: No ]
- 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) [ Designated as safety issue: No ]
- Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation.
Secondary
- To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
- To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus.
- To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine.
OUTLINE: This is a multicenter study.
Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell lymphocytes infusion over 5 minutes on day 1. Patients may receive up to 2 more doses at least 2 weeks after previous dose.
Blood samples are collected and analyzed by quantitative CMV PCR, chromium-release assays for CMV pp65- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45RA/RO. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and IFN-γ production by CD4 and CD8 CMV-specific effector cells.
After completion of study therapy, patients are followed periodically for up to 1 year.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769613
Locations
| United States, Pennsylvania | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
| Principal Investigator: | Kenneth G. Lucas, MD | Milton S. Hershey Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00769613 History of Changes |
| Other Study ID Numbers: | CDR0000615167, PSCI-PSHCI-08-051 |
| Study First Received: | October 8, 2008 |
| Last Updated: | August 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma |
stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Emergencies Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Herpesviridae Infections DNA Virus Infections Virus Diseases Disease Attributes |
Pathologic Processes Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013