A Feasibility Study of Prophylactic White Blood Cell Transfusions

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

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.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Procedure: White Blood Cell Transfusion

Detailed Description

Study Procedures:

During each white blood cell transfusion, you will receive white blood cells from a volunteer donor through a needle in your vein. Each transfusion will take anywhere from 1 hour to several hours, depending on how you tolerate the treatment. You will receive a transfusion approximately every 3-4 days (2 a week) for up to 6 weeks.

Before each white blood cell transfusion, your vital signs (temperature, heart rate, breathing rate, and blood pressure) will be recorded according to standard evaluation of patients with fever to look for underlying infectious causes. During and for 1 hour after the transfusion, you will be monitored for side effects. You may be given a drug to help or reduce any side effects. Your doctor will tell you more about any drug that may be given for side effects.

If at any point you develop a fever while on study, blood (about 1 teaspoon) and urine will be collected to check for infection according to standard evaluation of patients with fever to look for underlying infectious causes. You may also have a chest x-ray. If it is abnormal or if you have symptoms (cough, shortness of breath, nasal congestion), you may need a computed tomography (CT) scan of the chest and/or sinuses. That will be done within 3 days of developing a fever. If the doctor thinks it is needed, you will than have another CT scan 2 weeks later and at any other point that the doctor thinks it are needed to check for infection.

Length of Study:

You will continue to have transfusions until the doctor thinks infection has been controlled or until your white blood cell counts stay at a certain level for at least 2 days in a row. If any point you are discharged from the hospital and your doctor wants you to continue receiving white blood cell transfusions, you will be able to receive them as an outpatient.

You will be monitored for side effects and signs of infection for up to 6 weeks. You will be taken off study if you have intolerable side effects.

This is an investigational study. Radiated white blood cell transfusions are considered to be a standard procedure for the treatment of serious infections. It is investigational to give unirradiated white blood cell transfusions as a way of preventing infections.

Up to 50 patients will take part in the study. All will be enrolled at MD Anderson.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: White Blood Cell Transfusion; Patient receives white blood cells by vein from a volunteer donor. Each transfusion will take anywhere from 1 hour to several hours, depending on how treatment is tolerated. Patient receives a transfusion every 3-4 days (at least 2 a week) for up to 6 weeks.	Procedure: White Blood Cell Transfusion; Patient receives white blood cells by vein from a volunteer donor. Each transfusion will take anywhere from 1 hour to several hours, depending on how treatment tolerated. Transfusion received every 3-4 days (at least 2 a week) for up to 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2013
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: AML; Leukemia; MDS; Acute myelogenous leukemia; Infection risk; Prophylactic therapy; High-risk myelodysplastic leukemia; White Blood Cell transfusion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: 2012-1158; NCI-2013-02208 (Registry Identifier: NCI CTRP)