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A Prospective Randomized Comparative Study of the Effect on Infections of Radiated Prophylactic White Cell Transfusions Versus Therapeutic Radiated White Cell Transfusions


Phase 2
2 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Prospective Randomized Comparative Study of the Effect on Infections of Radiated Prophylactic White Cell Transfusions Versus Therapeutic Radiated White Cell Transfusions


Study Groups:

If you are found to be eligible to take part of this study, and you are 1 of the first 60
participants to be enrolled, you will be randomly assigned (as in the flip of a coin) to 1
of 2 groups:

- If you are in Group 1, you will receive the standard of care drugs that are used to
prevent infections. You will also receive unirradiated white blood cell transfusions
2-3 times each week. If at any point you develop an infection, white blood cell
transfusions will then be given daily in addition to the standard treatment for the
infection.

- If you are in Group 2, you will receive the standard of care drugs that are used to
prevent infections. You will only receive unirradiated white blood cell transfusions
if at any point you develop an infection. You will receive these transfusions daily,
in addition to the standard treatment for the infection.

If you are not 1 of the first 60 participants to be enrolled, you will be assigned to the
study group that the study doctor decides is in your best interest. This will be decided
based on how the first participants have responded to the different treatments.

The drugs you receive as part of the standard therapy will be up the study doctor.

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.

Before each white blood cell transfusion, your vital signs will be recorded. 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
is given for side effects.

While you are in the hospital for leukemia treatment, blood (about 1 teaspoon) will be drawn
to check for fungal infections 2-3 times each week. This test will be done 1 time each week
when you are not in the hospital until the doctor no longer thinks it is needed.

If at any point you develop a fever while on study, blood (about 1 teaspoon) will be drawn
to check for infection. You will also have a CT scan within 3 days of developing a fever.
If the doctor thinks it is needed, you will then have a CT scan 2 weeks later and at any
other point that the doctor thinks it is 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 at 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 2 cycles of
anti-leukemia treatment through a review of your medical record. 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 240 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Adult and pediatric (=/> 2 years old) patients with a diagnosis of acute myelogenous
leukemia (including undifferentiated and bi-phenotypic leukemia), or high-risk
myelodysplastic syndrome, or chronic myelogenous leukemia in blast crisis who will
receive first or second anti-leukemia therapeutic intent with chemotherapy, targeted
therapy or hypomethylating agents

2. Patients must sign an informed consent indicating they are aware of the
investigational nature of this study, in keeping with the policies of the hospital.

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 randomization; 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of Patients with Infection

Outcome Description:

Primary outcome is infection (yes/no) where patient without infection found by day 42 patient are counted as 'No' to infection.

Outcome Time Frame:

Blood draw 2-3 times a week while hospitalized, weekly thereafter. Patient will remain on study 42 days after transfusion.

Safety Issue:

No

Principal Investigator

Emil J Freireich, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0468

NCT ID:

NCT01204788

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Leukemia
  • Acute myelogenous leukemia
  • AML
  • Undifferentiated and bi-phenotypic leukemia
  • High-risk myelodysplastic syndrome
  • Chronic myelogenous leukemia
  • Infection
  • Radiated Prophylactic White Cell Transfusions
  • Therapeutic Radiated White Cell Transfusion
  • prophylactic antibiotics
  • Leukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030