Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 3, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
October 30, 2013
CompletedOctober 9, 2018
September 1, 2018
3.1 years
December 1, 2009
August 19, 2013
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery
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.
8 weeks after Induction therapy (induction cycle 4-6 weeks)
Median Event-Free Survival (EFS)
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.
2 years
Study Arms (1)
Clofarabine, Cytarabine + Idarubicin
EXPERIMENTALInduction 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
Interventions
Induction Cycle: 20 mg/m\^2 IV over approximately 1 hour daily for 5 days (days 1-5)
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
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of AML (World Health Organization (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.
- Eastern Cooperative Oncology Group (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 \* (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.
- Cardiac ejection fraction \>/= 45% (by either echocardiography or MUGA scan).
- Ability to understand and provide signed informed consent.
You may not qualify if:
- 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, intrauterine device (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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Genzyme, a Sanofi Companycollaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Morita K, Kantarjian HM, Wang F, Yan Y, Bueso-Ramos C, Sasaki K, Issa GC, Wang S, Jorgensen J, Song X, Zhang J, Tippen S, Thornton R, Coyle M, Little L, Gumbs C, Pemmaraju N, Daver N, DiNardo CD, Konopleva M, Andreeff M, Ravandi F, Cortes JE, Kadia T, Jabbour E, Garcia-Manero G, Patel KP, Futreal PA, Takahashi K. Clearance of Somatic Mutations at Remission and the Risk of Relapse in Acute Myeloid Leukemia. J Clin Oncol. 2018 Jun 20;36(18):1788-1797. doi: 10.1200/JCO.2017.77.6757. Epub 2018 Apr 27.
PMID: 29702001DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stefan Faderl, MD / Associate Professor
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- STUDY CHAIR
Stefan Faderl, MD
UT MD Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 3, 2009
Study Start
January 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
October 9, 2018
Results First Posted
October 30, 2013
Record last verified: 2018-09