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Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01025154
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : October 30, 2013
Last Update Posted : October 9, 2018
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Clofarabine Drug: Idarubicin Drug: Cytarabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clofarabine, Idarubicin, and Cytarabine Combination as Induction Therapy for Younger Patients With Acute Myeloid Leukemia (AML)
Study Start Date : January 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Clofarabine, Cytarabine + Idarubicin
Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
Drug: Clofarabine
Induction Cycle: 20 mg/m^2 IV over approximately 1 hour daily for 5 days (days 1-5)
Other Names:
  • Clofarex
  • Clolar

Drug: Idarubicin
Induction Cycle: 10 mg/m^2 IV over approximately 30 minutes daily for 3 days (days 1-3), following clofarabine by 1 to 2 hours
Other Name: Idamycin

Drug: Cytarabine
Induction Cycle: 1 g/m^2 IV over approximately 2 hours daily for 5 days (days 1-5), follow clofarabine by 3 to 6 hours.
Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride

Primary Outcome Measures :
  1. Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery [ Time Frame: 8 weeks after Induction therapy (induction cycle 4-6 weeks) ]
    Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L. Response evaluated within 8 weeks after induction therapy.

  2. Median Event-Free Survival (EFS) [ Time Frame: 2 years ]
    Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death. Bayesian time-to-event model will be used to monitor progression free survival.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of AML (World Health Organization (WHO) classification)
  2. Patients must be chemotherapy-naïve, i.e. not have received any prior cytotoxic chemotherapy for AML (with the exception of hydroxyurea). They could have received prior therapy with hypomethylating agents, targeted, or biological agents.
  3. Age 18 to 60 years.
  4. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  5. Serum creatinine </= 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73m^2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73m^2)=186 * (serum creatinine)^-1.154 x (age in years)^-0.023 * (0.742 if patient is female) * (1.212 if patient is black), where SCr is serum creatinine measured in mg/dL. serum bilirubin </= 1.5 * upper limit of normal (ULN) (unless increase is due to hemolysis or a congenital disorder); serum transaminases (SGPT and/or SGOT) </= 2.5 * ULN.
  6. Cardiac ejection fraction >/= 45% (by either echocardiography or MUGA scan).
  7. Ability to understand and provide signed informed consent.

Exclusion Criteria:

  1. Patients with acute promyelocytic leukemia (APL).
  2. Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
  3. Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of therapy.
  4. Active and uncontrolled infection requiring therapy with IV antibiotics or antifungal therapy. Prior or concurrent history of one or more opportunistic infections (e.g., cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01025154

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
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Study Chair: Stefan Faderl, MD UT MD Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01025154    
Other Study ID Numbers: 2009-0431
First Posted: December 3, 2009    Key Record Dates
Results First Posted: October 30, 2013
Last Update Posted: October 9, 2018
Last Verified: September 2018
Keywords provided by M.D. Anderson Cancer Center:
Cytosine Arabinosine Hydrochloride
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors