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

University of Florida

Status and phase

Terminated

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT04914676

IRB202003214 (Other Identifier)

UF-HEM-009

OCR40160 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

All

Ages

61 to 99 years old

Volunteers

No Healthy Volunteers

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