Trial Information

Ultrafiltration (Aquapheresis) in the Management of Patients With Leukemia and Severe Fluid Overload

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study
group based on when you join this study. The first group of 10 participants to join the
study will be enrolled in the Pilot portion of the study. The next group of up to 40
participants will be enrolled in the Randomized portion of the study.

In the Pilot portion of the study, researchers want to learn about the safety and level of
effectiveness of aquapheresis in leukemia patients with severe fluid overload who do not
respond to diuretics.

If you are in the Randomized portion of the study, you will be randomly assigned (as in the
flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to each
group.

- Group A will receive aquapheresis.

- Group B will receive furosemide. The doctor will discuss this with you.

If you are in Group A, you will be connected to the aquapheresis pump through an intravenous
(IV) catheter placed in your forearm. The pump looks like the ones used to infuse IV drugs.
It will hang on a pole by your bed. About 6 teaspoons of your blood will flow through the
blood circuit, and the excess fluid will slowly be collected in the collection bag. The
exact length of time of aquapheresis treatment is determined by how much fluid needs to be
removed and how fast it can be removed. The average treatment is about 24 hours but can
extend up to 7 days. About 6 liters or 13 pounds will be removed.

If you are in Group B, you will receive one of the following for as the doctor thinks it is
needed (until most of the excess fluid is removed):

- furosemide by vein over about 15 minutes every 8 hours

- furosemide by vein as a continuous (non-stop) infusion

Both Groups:

If the doctor thinks it is needed, you will be given other standard of care drugs such as
albumin and metolazone to help your kidneys to make more urine. The study staff will tell
you about these drugs, how they will be given, and the possible risks.

Study Visits:

Every day while you are receiving aquapheresis or diuretic treatment:

- You will be asked about any symptoms you may be having.

- You will have a physical exam, including measurement of your vital signs (blood
pressure, heart rate, and breathing rate) and weight.

- You will be asked how much you drank. The study staff will measure how much you
urinate.

- Your leg will be measured for swelling due to fluid retention.

At least every other day, blood (about 4 teaspoons) will be drawn for routine tests.

If the doctor thinks it is needed, you will have a chest x-ray on Day 3.

Length of Participation:

If you are in Group A, you will remain on study treatment for as long as the doctor thinks
it is needed (possibly about 1-7 days).

If you are in Group B, you will receive standard treatment for as long as your doctor thinks
it is needed.

You will no longer be able to receive the study treatment (Group A) or you will be taken off
study (Group B) if intolerable side effects occur or if you are unable to follow study
directions.

Your participation on the study will be over once you have completed the end-of-study
follow-up visit.

End-of-Treatment Visit:

After you stop taking the study treatment or standard treatment, the following tests and
procedures will be performed:

- You will be asked about any symptoms you may be having.

- You will have a physical exam, including measurement of your vital signs and weight.

- You will be asked how much you drank. The study staff will measure how much you
urinate.

- Your leg will be measured for swelling due to fluid retention.

- Blood (about 4 teaspoons) will be drawn for routine tests.

- If the doctor thinks it is needed, you will have a chest x-ray.

End-of-Study Follow-up Visit:

At 30 days after the end of study therapy:

- You will have a physical exam, including measurement of your vital signs and weight.

- You will be asked about any symptoms you may be having.

- Your leg will be measured for swelling due to fluid retention.

This is an investigational study. The Aquadex FlexFlow™ Fluid Removal Systems pump used for
aquapheresis is FDA approved and commercially available for patients with fluid overload.
Using the Aquadex FlexFlow™ Fluid Removal Systems pump in patients with leukemia to remove
excess fluid is investigational. Furosemide is FDA approved and commercially available for
other uses such as the treatment of swelling caused by heart failure or kidney or liver
problems.

Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.