Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/22/2018
Start Date:October 2014
End Date:October 2027
Contact:Guillermo Garcia-Manero, MD
Phone:713-745-3428

Use our guide to learn which trials are right for you!

Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 5 Days Every Month) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Dependent Versus Best Supportive Care (BSC) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Independent

The goal of this clinical research study is to compare how 2 different drugs, decitabine and
azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS.
The safety of each study drug given on these schedules will also be studied.

This is an investigational study. Decitabine and azacitidine are both FDA approved and
commercially available for use in patients with MDS. Giving these drugs on a different
schedule than is standard is considered investigational.

The study doctor can tell you how the study drugs are designed to work.

Up to 240 participants will be enrolled in this multicenter study. Up to 157 will take part
at MD Anderson.

Study Groups and Study Drug Administration:

Each cycle is approximately 28 days.

If you are found to be eligible to take part in this study, you will be randomly assigned (as
in the roll of dice) to 1 of 4 groups:

- If you are in Group 1, you will receive decitabine by vein over about 1 hour on Days 1-3
of every cycle.

- If you are in Group 2, you will receive azacitidine either as an injection under your
skin or by vein on Days 1-3 of every cycle.

- If you are in Group 3, you will receive azacitidine either as an injection under your
skin or by vein on Days 1-5 of every cycle.

- If you are in Group 4, you will receive the standard of care. The study doctor can
explain the treatment you will receive and the risks involved.

Transfusion-dependent participants will be randomly assigned to 1 of 3 groups

This is done because no one knows if one study group is better, the same, or worse than the
other group. If you are among the first 20 participants, you will have an equal chance of
being in any of the groups. If you enroll after that, you will have a higher chance of being
assigned to the group that has had better results.

However, once you are assigned to a group, you will not be allowed to change groups.

You may be given other drugs to help prevent side effects. The study staff will tell you
about these drugs, how they will be given, and the possible risks.

Study Visits:

One (1) time each month, blood (about 2 tablespoons) will be drawn for routine tests.

At the end of Cycle 2, then every 3 cycles for the first year, then every 6 cycles, you will
have a bone marrow biopsy and/or aspirate to check the status of the disease and for
cytogenetic testing.

After Cycle 1, if the study doctor decides it is acceptable, you may be allowed to receive
treatment from your local cancer doctor. However, you must return to Houston at least every 3
cycles for study visits. How often these visits will occur will depend on what the doctor
thinks is in your best interest.

Length of Study:

You may continue taking the study drug or standard therapy for as long as the doctor thinks
it is in your best interest. You will no longer be able to take the study drug or standard
therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to
follow study directions.

Follow-Up:

When you are off-treatment, every 6 -12 months for up to 5 years, you will be called by a
member of the study staff. You will be asked about any side effects you may be having. The
phone calls will take about 5-10 minutes.

Inclusion Criteria:

1. Sign an IRB-approved informed consent document.

2. Age >/= 18 years.

3. IPSS low- or intermediate-1-risk MDS, including CMML-1

4. ECOG performance status of
5. Organ function defined as: Serum creatinine ALT (SGPT)
6. Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days and will also need to use contraceptives. Men must agree not to father a
child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

1. Breast feeding females

2. Prior therapy with decitabine or azacitidine
We found this trial at
6
sites
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
?
mi
from
New York, NY
Click here to add this to my saved trials