Parts of the Study:
There will be 2 parts to this study. The first part of the study is called induction therapy.
During induction, the study doctor will try to get rid of the leukemia cells from your bone
marrow. If induction causes the leukemia cells to be removed from your bone marrow and your
blood counts return to normal, you will be in remission. Induction usually lasts 4-6 weeks.
If you are in remission, you will begin the second part of the study, called post-remission
therapy. You will receive up to 4-6 cycles (1 cycle every 4-6 weeks) of post-remission
therapy, depending on your blood counts. Each study cycle lasts 4-6 weeks.
Study Drug Administration:
If you are found to be eligible to take part in this study, during induction therapy, you
will be given fludarabine and cytarabine through a needle in your vein every day, for 5 days
in a row (Days 1-5). You will receive fludarabine over 30 minutes and cytarabine over 4
Filgrastim will be given one time daily as an injection just under the skin starting on the
day before you receive fludarabine and cytarabine, and you will continue to receive
filgrastim one time daily until your white blood cell count is near normal.
Once you complete chemotherapy, your doctor may decide to give a dose of pegfilgrastim
instead of daily filgrastim.
You will receive idarubicin through a needle in your vein over 30 minutes on Days 3 and 4
right after you receive fludarabine. You will receive gemtuzumab on Day 1 through by vein
over 2 hours. If you are 66 years or older, and the doctor thinks it is in your best
interest, you will receive fewer days of cytarabine, fludarabine and idarubicin. The doctor
will discuss this with you.
Gemtuzumab may cause allergic reactions, nausea, and vomiting. To help prevent such side
effects, you will receive Tylenol (acetaminophen), Benadryl (diphenhydramine) and
corticosteroids. You can receive these drugs by vein, or by mouth.
During post-remission therapy, you will receive fludarabine and cytarabine for 3 days (Days
1-3) instead of 5 days. During Cycle 4 of post-remission therapy, you will receive idarubicin
at the same dose as given during induction therapy on Days 2 and 3.
During either Cycles 2 or 3, and or in Cycles 5 or 6 of post-remission therapy, you will
receive gemtuzumab at the same dose as given during induction.
You will receive filgrastim one time on the day before each post-remission cycle and you will
continue to receive filgrastim one time daily until your white blood cell count is near
Your doctor may decide to give a dose of pegfilgrastim instead of daily filgrastim
During post-remission therapy, you may begin receiving decitabine instead of fludarabine,
cytarabine, filgrastim, gemtuzumab, and idarubicin if you are 60 years or older, or if you
have had intolerable side effects. If the doctor thinks it is in your best interest, you will
begin receiving decitabine infusions over 1 hour, for 5 days in a row, every 4-6 weeks for up
to 12 cycles. The doctor will discuss this with you.
During induction therapy, blood (about 2 teaspoons) will be drawn at least once a week for
After 3 weeks (Between Days 18-24), you will have a bone marrow aspirate to check the status
of the disease. If the leukemia cells are not completely gone from your bone marrow by the
end of 3 weeks, your study doctor may decide to repeat the test.
If the repeat bone marrow aspirate shows that you are not in remission, your study doctor may
decide to give you another cycle of induction therapy.
Once you begin post-remission therapy, you will have the following tests and procedures:
- You will have a physical exam, including measurement of your vital signs, including your
- You will be asked how well you are able to perform the normal activities of daily living
- Blood (about 2 teaspoons) will be drawn for routine blood tests.
At Months 4 and 7, you will have a bone marrow aspirate to check the status of the disease.
Part of the bone marrow sample collected at these bone marrow aspirations will be sent to the
M.D. Anderson molecular lab for testing.
If your study doctor thinks it is necessary, you may have a bone marrow aspirate after the
first 7 months to check the status of the disease.
Length of Study:
You will be on study for one cycle of induction therapy and up to 6 cycles of post-remission
therapy. You will be taken off study if the disease gets worse or intolerable side effects
Long-term follow up:
You will have blood (about 2 teaspoons) drawn for routine testing every 6 months for 2 years
after the study.
1. Patients must have untreated AML, or high-risk MDS [refractory anemia with excess
blasts, (RAEB), or RAEB "in transformation" (RAEB-t)] characterized by t(8;21),
inv(16), or t(16;16).The presence of additional abnormalities is irrelevant.
2. Age equal to or greater than 18 years (the safety of GO in patients <18 years is not
determined and advantage of fludarabine, cytarabine, idarubicin-based regimen in CBF
leukemias in children is not demonstrated).
3. Patients must provide written consent.
4. Because of the high possibility of CR in CBF leukemias, participants will not be
excluded based on performance status.For patients with Eastern Co-operative Oncology
Group (ECOG) performance status >/= to 3 the dosing schedule will be discussed with
5. Patients with organ dysfunction will not be excluded from the study. For patients with
evidence of organ dysfunction (creatinine >/= 1.5, cardiac ejection fraction </= 50%,
total bilirubin >/=2 and AST/ALT >/= 3 times ULN, dose adjustments/omissions will be
6. Up to one cycle of prior induction therapy will be permitted to include patients in
whom presence of "good-risk" cytogenetics was initially missed. If the patient is in
remission from induction therapy, he/she will receive post-remission therapy. If the
patient is not in remission then he/she will receive induction therapy.
7. Patients of child bearing potential should practice effective methods of
1) Pregnant and lactating females will be excluded since the safety of GO or FLAG + Ida in
pregnancy and lactation is unknown.