Clinical trial · Interventional

Measuring Changes in Blood in Patients at High Risk of Cytomegalovirus Infection After Undergoing Donor Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant

CMV Specific Cellular Immunity in Recipients of Allogeneic Bone Marrow Transplantation: Association of CMV-Specific HLA-Peptide Tetramer Binding With Cytotoxic T-Cell Function, CMV Infection and Other Clinical Events

NCT00716911CI-TRIAL-00018200completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Tests that measure certain changes in blood in patients at high risk of cytomegalovirus infection may help doctors learn more about predicting cytomegalovirus infection after donor stem cell transplant. PURPOSE: This clinical trial is studying tests that measure changes in the blood in patients at high risk of cytomegalovirus infection after undergoing donor bone marrow transplant or peripheral stem cell transplant.

Conditions

Conditions (7)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Nonneoplastic Condition	—	UNRESOLVED	—

Interventions

Interventions (8)

Intervention	Type	Mapped drug	Match
allogeneic bone marrow transplantation	Procedure	—	UNRESOLVED
allogeneic hematopoietic stem cell transplantation	Procedure	—	UNRESOLVED
assessment of therapy complications	Procedure	—	UNRESOLVED
flow cytometry	Other	—	UNRESOLVED
ganciclovir	Drug	—	UNRESOLVED
immunologic technique	Other	—	UNRESOLVED
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED
polymerase chain reaction	Genetic	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (4)

measure
Quantitative determination of HLA-peptide tetramer-binding assay (TBA) pp65 on days 40 and 90 after stem cell transplantation, with and without in vitro stimulation
measure
Comparison of quantitative determination of TBApp65 with concomitant determination of in vitro CMV-specific cytotoxic T-lymphocyte function on days 40 and 90 after stem cell transplantation
measure
Correlation of TBApp65 results with CMV viral loads
measure
Correlation of TBApp65 results with CMV-associated complications

Secondary outcomes (1)

measure
Correlation of TBApp65 results with clinical events, including acute graft-versus-host-disease (GVHD), chronic GVHD, ganciclovir exposure, and survival

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria at the City of Hope National Medical Center:

  * Patient who has undergone a matched-related or matched-unrelated allogeneic bone marrow or peripheral blood stem cell transplantation (SCT) for a hematological malignancy (e.g., aplastic anemia or myelodysplastic syndromes)

    * At risk for cytomegalovirus (CMV) infection and disease due to 1 of the following risk factors:

      * CMV-seropositive prior to transplantation
      * Received SCT from a CMV-seropositive donor
  * Donor for matched-related SCT
  * Healthy volunteer evaluated concurrently with SCT recipients to establish normal values for both CMV-seronegative and CMV-seropositive persons
* Any HLA serotypes allowed

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

References

Publications (1)

DERIVEDLacey SF, La Rosa C, Kaltcheva T, Srivastava T, Seidel A, Zhou W, Rawal R, Hagen K, Krishnan A, Longmate J, Andersson HA, St John L, Bhatia R, Pullarkat V, Forman SJ, Cooper LJ, Molldrem J, Diamond DJ. Characterization of immunologic properties of a second HLA-A2 epitope from a granule protease in CML patients and HLA-A2 transgenic mice. Blood. 2011 Aug 25;118(8):2159-69. doi: 10.1182/blood-2011-04-349951. Epub 2011 Jun 30. PMID 21719601

Registry

Dates and enrollment