Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With Acute Myeloid Leukemia (AML), High Risk Myelodysplastic Syndrome (HR MDS) or Myeloid Blast Phase of Chronic Myeloid Leukemia (CML)
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology, Leukemia |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 6/29/2018 |
Start Date: | May 2014 |
End Date: | May 2019 |
Contact: | Tapan Kadia, MD |
Phone: | 713-792-7305 |
Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With Acute Myeloid Leukemia (AML), High Risk Myelodysplastic Syndrome (HR MDS) or Myeloid Blast Phase of Chronic Myeloid Leukemia (CML)
The goal of this clinical research study is to learn if the combination of cladribine,
idarubicin, and cytarabine can help to control AML, high risk MDS, and/or CML in blast phase.
Midostaurin may also be added to the combination for patients with a specific type of AML and
the affect on the disease will be studied. The safety of these drugs will also be studied.
This is an investigational study. Cladribine, cytarabine, and idarubicin are all FDA approved
and commercially available for the treatment of different kinds of leukemia Midostaurin is
FDA approved and commercially available to treat a specific type of AML in combination with
chemotherapy. It is investigational to use these drugs in combination with each other. The
study doctor can explain how the study drugs are designed to work.
Up to 308 patients will take part in this study. All will be enrolled at MD Anderson.
idarubicin, and cytarabine can help to control AML, high risk MDS, and/or CML in blast phase.
Midostaurin may also be added to the combination for patients with a specific type of AML and
the affect on the disease will be studied. The safety of these drugs will also be studied.
This is an investigational study. Cladribine, cytarabine, and idarubicin are all FDA approved
and commercially available for the treatment of different kinds of leukemia Midostaurin is
FDA approved and commercially available to treat a specific type of AML in combination with
chemotherapy. It is investigational to use these drugs in combination with each other. The
study doctor can explain how the study drugs are designed to work.
Up to 308 patients will take part in this study. All will be enrolled at MD Anderson.
Study Drug Administration:
If participant is found to be eligible to take part in this study, participant will receive
treatment in 2 different parts: the Induction Cycle and the Consolidation Cycles. Participant
will have 1 cycle of induction therapy first, followed by up to 5 cycles of consolidation
therapy. Participant's doctor will tell participant how many cycles participant will have.
This will be based on any response participant may have to the therapy.
Each cycle is 28 days.
During the Induction Cycle, on Days 1-5, participant will receive cladribine and cytarabine
by vein over 1-2 hours. On Days 1-3, participant will receive idarubicin by vein over 30-60
minutes.
During the Consolidation Cycles, on Days 1-3, participant will receive cladribine and
cytarabine by vein over 1-2 hours. On Days 1-2, participant will receive idarubicin by vein
over 30-60 minutes.
If you have a certain type of AML, participant may take midostaurin by mouth 2 times a day on
Days 6-20 of Induction and Consolidation. Participant's doctor will discuss this option with
participant. Midostaurin should be taken with food.
If the disease has not started to get better after the first cycle, participant may receive
an additional induction cycle, followed by 4 consolidation cycles.
If participant misses a dose of study drug and the doctor approves, participant may make it
up within 7 days after the first dose. If participant misses a dose, it is very important
participant tells the doctor as soon as possible. The doctor will tell participant if
participant can "make up" the dose or if participant should wait and take your next dose as
scheduled.
Study Visits:
At the beginning of every cycle, participant will have a physical exam.
Blood (about 2 tablespoons) will be drawn for routine tests at least 1 time a week. If the
disease starts to get better, the blood draws will happen every 2-4 weeks while participant
is taking the study drug. After participant's last dose of study drug, the blood draws will
happen every 4-8 weeks as long as participant is on study.
On Day 28 (+/- 7 days) of the first cycle participant will have a bone marrow biopsy and/or
aspirate to check the status of the disease. Participant may have another bone marrow biopsy
and/or aspirate later in the study if participant's doctor thinks it is needed.
During treatment, participant will come to the clinic at least 1 time each week for the first
month and then at least 1 time a month after that until you stop treatment. If the study
doctor thinks it is needed, participant may have additional clinic visits after participant
stops treatment.
Length of Treatment:
Participant may continue taking the study drugs for up to 6 cycles. Participant will no
longer be able to take the study drug if the disease gets worse, if intolerable side effects
occur, or if participant is unable to follow study directions.
Participation on the study will be over when participant has completed follow-up.
Follow-Up Visits:
After participant's last dose of study drug, participant will be called every 6 -12 months by
a member of the study staff to ask about any side effects participant may be having. The
phone call should take about 5-10 minutes. Participant will continue to be called for as long
as possible.
Participant will continue to have blood (about 2 tablespoons) drawn for routine tests every
4-8 weeks while participant is on study. Participant may also need to have additional blood
draws as part of participant's standard of care.
If participant is found to be eligible to take part in this study, participant will receive
treatment in 2 different parts: the Induction Cycle and the Consolidation Cycles. Participant
will have 1 cycle of induction therapy first, followed by up to 5 cycles of consolidation
therapy. Participant's doctor will tell participant how many cycles participant will have.
This will be based on any response participant may have to the therapy.
Each cycle is 28 days.
During the Induction Cycle, on Days 1-5, participant will receive cladribine and cytarabine
by vein over 1-2 hours. On Days 1-3, participant will receive idarubicin by vein over 30-60
minutes.
During the Consolidation Cycles, on Days 1-3, participant will receive cladribine and
cytarabine by vein over 1-2 hours. On Days 1-2, participant will receive idarubicin by vein
over 30-60 minutes.
If you have a certain type of AML, participant may take midostaurin by mouth 2 times a day on
Days 6-20 of Induction and Consolidation. Participant's doctor will discuss this option with
participant. Midostaurin should be taken with food.
If the disease has not started to get better after the first cycle, participant may receive
an additional induction cycle, followed by 4 consolidation cycles.
If participant misses a dose of study drug and the doctor approves, participant may make it
up within 7 days after the first dose. If participant misses a dose, it is very important
participant tells the doctor as soon as possible. The doctor will tell participant if
participant can "make up" the dose or if participant should wait and take your next dose as
scheduled.
Study Visits:
At the beginning of every cycle, participant will have a physical exam.
Blood (about 2 tablespoons) will be drawn for routine tests at least 1 time a week. If the
disease starts to get better, the blood draws will happen every 2-4 weeks while participant
is taking the study drug. After participant's last dose of study drug, the blood draws will
happen every 4-8 weeks as long as participant is on study.
On Day 28 (+/- 7 days) of the first cycle participant will have a bone marrow biopsy and/or
aspirate to check the status of the disease. Participant may have another bone marrow biopsy
and/or aspirate later in the study if participant's doctor thinks it is needed.
During treatment, participant will come to the clinic at least 1 time each week for the first
month and then at least 1 time a month after that until you stop treatment. If the study
doctor thinks it is needed, participant may have additional clinic visits after participant
stops treatment.
Length of Treatment:
Participant may continue taking the study drugs for up to 6 cycles. Participant will no
longer be able to take the study drug if the disease gets worse, if intolerable side effects
occur, or if participant is unable to follow study directions.
Participation on the study will be over when participant has completed follow-up.
Follow-Up Visits:
After participant's last dose of study drug, participant will be called every 6 -12 months by
a member of the study staff to ask about any side effects participant may be having. The
phone call should take about 5-10 minutes. Participant will continue to be called for as long
as possible.
Participant will continue to have blood (about 2 tablespoons) drawn for routine tests every
4-8 weeks while participant is on study. Participant may also need to have additional blood
draws as part of participant's standard of care.
Inclusion Criteria:
1. Patients with a diagnosis of AML, Acute Biphenotypic Leukemia, or high risk MDS (>/=
10% blasts or IPSS >/= intermediate-2) will be eligible. Patients with CML in Myeloid
Blast Phase are also eligible.
2. For Frontline cohort: No prior potentially-curative therapy for leukemia. Prior
therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, ATRA,
or a total dose of cytarabine up to 2g (for emergency use for stabilization) is
allowed. Patients with secondary AMLwho have been treated for their antecedent myeloid
neoplasm will be enrolled into the separate Secondary AML cohort.
3. For Salvage cohort: Patients with previously treated, relapsed or refractory AML,
Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.
4. Age = 65 years.
5. Adequate organ function as defined below: liver function (bilirubin =2mg/dL, AST
and/or ALT =3 x ULN- or <5 x ULN if related to leukemic involvement), kidney
function (creatinine =1.5 x ULN ), known cardiac ejection fraction of > or = 45%
within the past 6 months
6. ECOG performance status of = 2.
7. A negative urine pregnancy test is required within 1 week for all women of
childbearing potential prior to enrolling on this trial.
8. Patient must have the ability to understand the requirements of the study and signed
informed consent. A signed informed consent by the patient or his legally authorized
representative is required prior to their enrollment on the protocol.
Exclusion Criteria:
1. Pregnant women are excluded from this study because the agents used in this study have
the potential for teratogenic or abortifacient effects. Because there is a potential
risk for adverse events in nursing infants secondary to treatment of the mother with
the chemotherapy agents, breastfeeding should also be avoided.
2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled
infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable
angina pectoris, clinically significant cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements.
3. Patient with documented hypersensitivity to any of the components of the chemotherapy
program.
4. Men and women of childbearing potential who do not practice contraception. Women of
childbearing potential and men must agree to use contraception prior to study entry
and for the duration of study participation.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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