Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Modified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune Function
| Verified date | November 2017 |
| Source | City of Hope Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV)
infection caused by a stem cell transplant.
PURPOSE:This clinical trial studies infection prophylaxis and management in treating
cytomegalovirus infection in patients with hematologic malignancies previously treated with
donor stem cell transplant.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis: hematologic malignancies/disorders including aplastic anemia and myelodysplastic syndrome - Procedure: first allogeneic, T cell-replete transplantation of stem-cells from peripheral blood or bone marrow of an human leukocyte antigen (HLA) matched, unrelated or nonsyngeneic sibling donor - CMV seropositive donor and/or recipient - Performance level: must have already been determined to be eligible for HCT at City of Hope (COH) - Organ function requirements: The minimum organ function requirements should be the same as the requirements for HCT - Informed Consent: All patients must be capable of signing a written informed consent and no consent can be provided by a legal guardian Exclusion Criteria: - The recipient had prior polymerase chain reaction (PCR) positive CMV infection in blood or organ-specific disease in the past 12 months - The source of hematopoietic stem cells is T-cell depleted - Concomitant anti-graft-versus-host disease (GVD) treatment includes in vivo T cell depletion - Recipient is human immunodeficiency virus (HIV)-1 positive - No prior allogeneic HCT (Allo HCT) (autologous HCT [Auto HCT] is allowed) |
| Country | Name | City | State |
|---|---|---|---|
| United States | City of Hope Medical Center | Duarte | California |
| Lead Sponsor | Collaborator |
|---|---|
| City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Initiation of anti-CMV therapy | Subjects will not be considered treated with anti-CMV agents unless at least 4 consecutive days of therapy are completed. | Day 80 post stem cell transplant | |
| Primary | Diagnosis of CMV pneumonia | Confirmed by detection of CMV in bronchoalveolar lavage or lung biopsy. Reported overall and separately for those whose preemptive management was and was not modified (postponed or foregone or limited to a false start) and compared to corresponding incidence in a similar cohort at our institution. | 1 year | |
| Secondary | CMV reactivation-free survival, monitored using a real time PCR assay for CMV DNA in plasma | Modeled using proportional hazards regression. Primary risk factors will be donor KIR of interest (activating KIR2DS2 and 2DS4, inhibitory KIR2DL1, 2DL2/2DL3, 3DL1, 3DL2), together with their recipient ligands where known. Potential confounding factors to be controlled in the model will include established clinical risk factors, including pretransplant CMV serostatus of donor and recipient, unrelated donor, marrow versus peripheral blood stem cells, and onset of acute graft-versus-host disease, handled as a time-dependent variable. The proportionality of hazards over time will be verified. | Up to day 100 post-transplant | |
| Secondary | Percent cytotoxicity and ex vivo percent CD56+/CD107B+ cells | Studied longitudinally in generalized linear models. Each of the 2 markers of NK function will be modeled separately. | Day 120 post stem cell transplant |
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