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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 or = 45% within the past 6 months 6. Eastern Cooperative Oncology Group (ECOG) performance status of

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

Page last updated: August 23, 2015

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