Clofarabine Plus Low-Dose Cytarabine for the Treatment of Patients With Higher-Risk Myelodysplastic Syndrome (MDS) Who Have Been Relapsing After, or Are Refractory to, Hypomethylator Therapy
If you are found to be eligible to take part in the study, on Days 1-5 of each cycle , you
will receive clofarabine by vein over 1-2 hours.
On Days 1-7 of each cycle, you will receive cytarabine by injection under the skin over
several seconds 2 times a day.
You may receive up to 3 cycles at this dose and schedule (also called "induction cycles").
There are 7 treatment days in each cycle but the total length of one cycle (including rest
and recovery period) is usually between 4 and 8 weeks.
After you have completed the Induction Cycles, if you show a response to treatment, you can
then continue with up to a total of 12 more cycles of therapy, which will be called
"consolidation cycles". Not every participant may be able to receive all 12 consolidation
cycles. The actual number that you will receive depends on whether or not you maintain the
response and how you are able to tolerate ongoing therapy. There will be 4-8 weeks between
each consolidation cycle depending on any side effects you may be having and your blood
During consolidation cycles you will receive clofarabine on Days 1-3 by vein over 1-2
hours. You will receive cytarabine by injection under the skin over several seconds 2 times
a day .
Induction and Consolidation Cycles:
On the days when you receive clofarabine and cytarabine (Days 1-5 during induction and Days
1-3 during consolidation), the clofarabine will be given about 3-6 hours before the
cytarabine injections. You can be taught to give cytarabine injections to yourself. In this
case, you can leave the clinic after receiving clofarabine. You will be required to record
the injections of cytarabine in a diary unless you receive the treatments while you are in
On Day 1 of every cycle (+/- 7 days):
- You will have a physical exam, including measurements of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1-2 teaspoons) will be drawn for routine tests.
About 4 weeks after you started your first cycle, you may have a bone marrow aspirate to
check the status of the disease. After that, you may have repeat bone marrow aspirates when
the doctor thinks it is needed.
It is recommended that you stay in Houston for up to the first 4 weeks of treatment. After
that, you will need to return to Houston before each induction cycle. If you continue with
the consolidation you can receive these treatments by your local oncologist. However, you
have to return to Houston at least every 3 months for your study visits.
Length of Study:
You may continue taking the study drugs for up to 15 cycles. You will no longer be able to
take the study drugs if the disease gets worse, if intolerable side effects occur, or if you
are unable to follow study directions.
This is an investigational study. Clofarabine is FDA approved and commercially available
for use in pediatric patients with acute lymphoblastic leukemia. Its use in adults and in
patients with MDS is investigational.
Cytarabine is FDA approved and commercially available for use in patients with AML.
Up to 80 patients will take part in this study. All be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Complete Response (CR)
Complete Response Criteria (CR must last for at least 4 weeks): Marrow: = 5% myeloblasts with normal maturation of all cell lines; Persistent dysplasia noted; Blood: Hemoglobin (Hb) >/= 11 g/dL (untransfused, patient not on EPO); Neutrophils >/= 1x109/L (not on myeloid growth factor); Platelets >/= 100 * 109/L (not on thrombopoietic agent); No blasts. Bone marrow aspirate and/or biopsy at the end of course 1 (day 28 +/- 7 days). The method of Thall, Simon, and Estey used to monitor response.
4 weeks after first cycle
Stefan Faderl, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|