Status:
COMPLETED
Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of azacitidine when given together with cytarabine and mitoxantrone hydrochloride in treating patients with high-risk acute myeloid leukemia. ...
Detailed Description
PRIMARY OBJECTIVES: I. To establish the recommended phase II dose of 5-azacytidine (azacitidine) when combined with high-dose cytarabine (HiDAC) and mitoxantrone (mitoxantrone hydrochloride) chemothe...
Eligibility Criteria
Inclusion
- Patients must have one of the following disease characteristics:
- Therapy-related myeloid neoplasm (t-MN) age \>= 18 years
- Patients must have received cytotoxic chemotherapy, radiation, or a drug known to affect the properties of deoxyribonucleic acid (DNA) or cell growth, prior to current diagnosis of therapy-related myeloid neoplasm (t-MN); this broad definition is meant to include any prior therapy with chemicals that affect DNA replication, DNA integrity, or DNA structure, or chemicals that alter cell growth; this includes traditional cytotoxic chemotherapy, newer immunologic agents that have been shown to have cytotoxic activities in addition to immunosuppressive functions, and other chemicals; note that patients with primary AML could be diagnosed with a t- MN if morphology/cytogenetic analysis clearly indicated that the second process is not a relapse of the original disease
- AML arising from an antecedent hematological disorder age \>= 18 years
- De novo AML in patients age \>= 60 years
- Relapsed and/or refractory AML \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- Male and female patients must use an effective contraceptive method during the study and for at least 6 months after study treatment
- Patients must be at least 2 weeks from major surgery, radiation therapy, participation in other investigational trials and must have recovered from clinically significant toxicities of these prior treatments
- Ability to understand and willingness to sign the informed consent form
Exclusion
- Concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol
- Diagnosis of acute promyelocytic leukemia (APL)
- Use of investigational agents/any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea (note: for patients with hyperleukocytosis \[white blood cell (WBC) \> 20,000/uL\], hydroxyurea \[and leukapheresis, if clinically indicated\] will be initiated and these patients will receive 5-azacytidine when the WBC count has decreased to =\< 20,000/uL; hydroxyurea can be overlapped with 5-azacytidine in selected cases, after consultation with the study chair; hydroxyurea must be discontinued before the initiation of the HiDAC/mitoxantrone chemotherapy)
- Prior treatment with 5-azacytidine followed immediately by HiDAC and mitoxantrone as proposed in this study (note: prior therapy with 5-azacytidine or decitabine or HiDAC or mitoxantrone would be allowed-in patients with relapsed/refractory disease- unless the prior therapy was identical to the schema/schedule proposed in this study)
- Active second cancer other than specified; active cancer refers to cancer that requires systemic chemotherapy or biological therapy within 6 months of the study entry; patients who have received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 6 months may participate in this study
- Have any other severe concurrent disease, or have a history of serious organ dysfunction (e.g. uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, infection, psychiatric illness) that may in the judgment of the treating physician/ principal investigator place the patient at undue risk to undergo treatment
- Pregnant or lactating patients
- Any significant concurrent illness that would, in the judgment of the treating physician/principal investigator, compromise patient safety or compliance, or study participation
Key Trial Info
Start Date :
June 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01839240
Start Date
June 6 2012
End Date
August 16 2019
Last Update
May 15 2020
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470