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| ID | Type | Description | Link |
|---|---|---|---|
| CRC-TU-ACE-CMV | |||
| 53325562 | |||
| EU-20974 |
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RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant.
PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. After undergoing an allogeneic peripheral blood stem cell transplantation (PBSCT) using an alemtuzumab-based conditioning regimen that also includes radiotherapy, patients are randomized to 1 of 2 treatment arms.
Blood samples are collected to assess CMV viral load by quantitative PCR.
After completion of study therapy, patients are followed once a week for 100 days and then once a month for 1 year.
PROJECTED ACCRUAL: A total of 18 patients with sibling donors and 21 patients with unrelated donors are accrued for each arm, resulting in a total of 78 patients accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adoptive immunotherapy | Biological | |||
| alemtuzumab | Biological | |||
| in vitro-treated peripheral blood lymphocyte therapy | Biological | |||
| foscarnet sodium | Drug | |||
| ganciclovir | Drug | |||
| polymerase chain reaction | Genetic | |||
| allogeneic hematopoietic stem cell transplantation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| CMV reactivation in the first year after ASCT measured by quantitative PCR |
| Measure | Description | Time Frame |
|---|---|---|
| CMV-specific T-cell reconstitution by detection of circulating T-cell responses to CMV in the first year after ASCT | ||
| Time to CMV reactivation | ||
| Use of antiviral therapy |
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DISEASE CHARACTERISTICS:
Planning allogeneic peripheral blood stem cell transplantation (PBSCT) using a conditioning regimen containing alemtuzumab and radiotherapy
Sibling or matched unrelated donor available
Patients and donor matched for ≥ one of the following HLA alleles:
No donors whose stem cells have already been collected and cryopreserved prior to transplant
Patient and donor must be CMV seropositive
Stem cell harvests ≥ 4.0 x 10^6 CD34 cells/kg
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Chen, MD | University Hospital Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Recruiting | Birmingham | England | B15 2SG | United Kingdom |
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| infection prophylaxis and management | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| standard follow-up care | Procedure |
| radiation therapy | Radiation |
| Incidence of secondary CMV reactivation and CMV disease |
| Incidence of acute and chronic graft-versus-host disease |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| D000074323 | Alemtuzumab |
| D017245 | Foscarnet |
| D015774 | Ganciclovir |
| D016133 | Polymerase Chain Reaction |
| D013812 | Therapeutics |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010746 | Phosphonoacetic Acid |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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