Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genzyme
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01025154
First received: December 1, 2009
Last updated: February 26, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Patient Response [ Time Frame: 8 weeks after Induction therapy (induction cycle 4-6 weeks) ] [ Designated as safety issue: Yes ]
| 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/m2 IV daily x 5 days; Idarubicin 10 mg/m2 IV daily x 3 days; Cytarabine 1 g/m2 IV daily x 5 days
|
Drug: Clofarabine
Induction Cycle: 20 mg/m2 IV over approximately 1 hour daily for 5 days (days 1-5)
Other Names:
Drug: Idarubicin
Induction Cycle: 10 mg/m2 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/m2 IV over approximately 2 hours daily for 5 days (days 1-5), follow clofarabine by 3 to 6 hours.
Other Names:
|
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:
- Diagnosis of AML (WHO classification)
- 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.
- Age 18 to 60 years.
- ECOG performance status </= 2.
- 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 x (serum creatinine)^-1.154 x (age in years)^-0.023 x (0.742 if patient is female) x (1.212 if patient is black), where SCr is serum creatinine measured in mg/dL. serum bilirubin </= 1.5 x upper limit of normal (ULN) (unless increase is due to hemolysis or a congenital disorder); serum transaminases (SGPT and/or SGOT) </= 2.5 x ULN.
- Cardiac ejection fraction >/= 45% (by either echocardiography or MUGA scan).
- Ability to understand and provide signed informed consent.
Exclusion Criteria:
- Patients with acute promyelocytic leukemia (APL).
- Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
- 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, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of therapy.
- 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
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
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 |
| Last Updated: | February 26, 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 Leukemia, Myeloid, Acute Leukemia, Myeloid 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 |
ClinicalTrials.gov processed this record on May 19, 2013