Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

  • STATUS
    Recruiting
  • End date
    Aug 24, 2026
  • participants needed
    58
  • sponsor
    University of Florida
Updated on 2 January 2022
remission
cytarabine
induction chemotherapy
consolidation therapy
blast cells

Summary

This phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (AML).

Details
Condition acute myelogenous leukemia, Acute Myeloid Leukemia, anll, acute myeloblastic leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia
Treatment cytarabine
Clinical Study IdentifierNCT04914676
SponsorUniversity of Florida
Last Modified on2 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Both males and females 61 years of age
A clinical diagnosis of de novo, non-M3 acute myeloid leukemia (AML) confirmed by greater than 20% blasts on diagnostic bone marrow biopsy who have completed induction chemotherapy and are confirmed in complete remission #1 (defined by < 5% myeloblasts on recovery bone marrow biopsy, Absolute neutrophil count > 1000/uL and platelets > 100x103/uL) and able to receive HiDAC consolidation #1
Patients on the prospective arm must be willing to have labs/clinic visits at UF Health Shands approximately every 48 hours +/- 24 hours after discharge from chemotherapy admission to be included
Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. For subjects on the historical arm, there will be a waiver of informed consent (as these patients may be deceased or not be available for retrospective consent)

Exclusion Criteria

Age < 61 years
Patients unable to provide informed consent for prospective arm
Secondary AML (documented history of antecedent hematological disorder, such as myelodysplastic syndrome or therapy-related AML) or chronic myeloid leukemia (CML) in blast crisis
Patients receiving, received, or who will receive a FLT3 inhibitor
Patients receiving, received, or who will receive an IDH1 or IDH2 inhibitor
Serum creatinine greater than 2 mg/dL
History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
For historical arm, subjects will be excluded if adequate data is not available in electronic medical record (e.g., if patient was followed by their local oncologist between chemotherapy cycles and labs/transfusions/clinic notes, etc. are not available)
Karnofsky performance status of 40 or less at study entry
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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