Clinical trial NCT04914676: Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission
Official title: Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) in Complete Remission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
high dose cytarabine
HiDAC
consolidation
chemotherapy schedule
bone marrow
elderly
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 5
Sex: ALL
Minimum age (years): 61
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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 in peripheral blood or on diagnostic bone marrow biopsy who have completed intensive 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. If prospective subjects cannot be followed at the UF site then telephone visits are allowed to follow for toxicity and transfusions. Records can be requested from subject's local physician office.
* 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

Primary outcomes:
measure: Duration of Neutropenia
timeFrame: 5 months
Secondary outcomes:
measure: Duration of Thrombocytopenia
timeFrame: 5 months
measure: Incidence of Documented Infections
timeFrame: 5 months
measure: Number of Transfusions
timeFrame: 4 months
measure: Readmission Rates and Length of Readmission Stay
timeFrame: 5 months
measure: Time to Next Treatment
timeFrame: 5 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jack Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: