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

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01025154
First received: December 1, 2009
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Drug: Clofarabine
Drug: Idarubicin
Drug: Cytarabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clofarabine, Idarubicin, and Cytarabine Combination as Induction Therapy for Younger Patients With Acute Myeloid Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Median Event-Free Survival (EFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death.


Enrollment: 63
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025154

Locations
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
Investigators
Study Chair: Stefan Faderl, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01025154     History of Changes
Other Study ID Numbers: 2009-0431
Study First Received: December 1, 2009
Results First Received: August 19, 2013
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
AML
chemotherapy-naïve
Clofarabine
Clofarex
Clolar
Idarubicin
Idamycin
Cytarabine
Ara-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Clofarabine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014