A Feasibility Study of Prophylactic White Blood Cell Transfusions

Completed · Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT01932710

Run by

M.D. Anderson Cancer Center

People needed

45

Starts

2013-09-20

Expected to finish

2016-11-30

Last updated by the study team

2018-01-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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.

You may not qualify if…

• 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.
• Patients with Zubrod performance status >/= 3.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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