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)
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: Cladribine (Drug); Cytarabine (Drug); Idarubicin (Drug); Phone Calls (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Tapan Kadia, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Overall contact: Tapan Kadia, MD, Phone: 713-792-7305
Summary
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. The safety of these drugs will also be studied.
Clinical Details
Official title: 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)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Complete Response Rate (CR)
Secondary outcome: Overall Response Rate (ORR)
Detailed description:
Study Drug Administration:
If participant is found to be eligible to take part in this study, they 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 them how many cycles they 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
over30-60 minutes.
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.
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 they are on study.
On Day 21 (+/- 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 their 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 they stop treatment. If the
study doctor thinks it is needed, participant may have additional clinic visits after they
stop 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 they are unable to follow study directions.
Patient's participation on the study will be over when they have completed follow-up.
Follow-Up Visits:
After participant's last dose of study drug, they will be called every 6 - 12 months by a
member of the study staff to ask about any side effects they 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 they are on study. Participant may also need to have additional blood draws
as part of their standard of care.
This is an investigational study. Cladribine, cytarabine, and idarubicin are all FDA
approved and commercially available for the treatment of different kinds of leukemia. 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 100 participants will take part in this study. All will be enrolled at MD Anderson.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
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 upper limit of normal (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. Eastern Cooperative Oncology Group (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.
Locations and Contacts
Tapan Kadia, MD, Phone: 713-792-7305
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information
University of Texas MD Anderson Cancer Center Website
Starting date: May 2014
Last updated: May 20, 2015
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