Leukemia Clinical Trial
Official title:
A Feasibility Study of White Blood Cell Transfusion for the Prevention of Infection in Acute Myelogenous Leukemia Patients Undergoing Front-Line or First Salvage Induction Therapy
Verified date | January 2018 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with leukemia often have low white blood cell counts after chemotherapy, which puts
them at greater risk of infection. The standard of care for preventing infections is to give
these patients antibiotic, antifungal, and antiviral drugs during the time that white blood
cell counts are low. However, many patients still develop infections during chemotherapy.
Radiated white blood cell transfusions are a standard treatment once a patient develops a
severe infection.
The goal of this clinical research study is to learn if giving white blood cell transfusions
that are not radiated early in chemotherapy might delay or prevent infections in patients
with leukemia. Researchers also want to learn more about the type and severity of any
infections that do occur.
Status | Completed |
Enrollment | 45 |
Est. completion date | November 30, 2016 |
Est. primary completion date | November 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. All acute myelogenous leukemia and high-risk myelodysplastic leukemia patients who are admitted to the leukemia service and those who are referred from other services (i.e. pediatrics, medical oncology, etc.) will be eligible for the study. 2. Patients will be undergoing initial therapy for their disease or undergoing first salvage treatment, i.e. patients who fail therapy, or respond and relapse after initial therapy. 3. Patients will be free of signs and symptoms of infection at the time of entering the study and, most importantly, will be encouraged to have sufficient donors to administer prophylactic white cell transfusion twice a week for six weeks in order to assess their effectiveness. Exclusion Criteria: 1. Patients with baseline (at start leukemia treatment) infection, defined as patients with a) fever and known positive cultures at the time of registration; or b) chest or sinus computed tomography with findings suggestive of pneumonia or sinusitis; or c) one positive galactomannan test >/= 1 or two positive galactomannan text >/= 0.5 to 1. 2. Patients with Zubrod performance status >/= 3. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Utilizing White Cell Transfusion as a Prophylactic Therapy | Study considered feasible if within one year, 20 patients enrolled with sufficient donors to donate white blood cells, two transfusion per week for six weeks (on average a total of 12 white blood transfusions per patient) to participate in the prophylactic therapy. | 6 weeks | |
Secondary | Infection Rate | For the secondary analysis, the infection rate with its 95% CI will be estimated for patients with and without sufficient donors, respectively. | 6 weeks |
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