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

NCT04914676 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: UF-HEM-009IRB202003214OCR40160
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia; high dose cytarabine; HiDAC; consolidation; chemotherapy schedule; bone marrow; elderly

Outcome Measures

Primary Outcomes (1)

• Duration of Neutropenia

  Determine the duration of neutropenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135.

  5 months

Secondary Outcomes (5)

• Duration of Thrombocytopenia

  5 months

• Incidence of Documented Infections

  5 months

• Number of Transfusions

  4 months

• Readmission Rates and Length of Readmission Stay

  5 months

• Time to Next Treatment

  5 months

Study Arms (2)

Prospective HiDAC Treatment (HiDAC 123)

EXPERIMENTAL

Subject on this arm will be treated with HiDAC prospectively.

Drug: Cytarabine

Historical HiDAC Treatment (HiDAC 135)

OTHER

Subjects on this arm will be historical controls who have previously received treatment with HiDAC.

Drug: Cytarabine

Interventions

Cytarabine DRUG

Subjects on this arm will prospectively receive consolidation therapy with cytarabine. Subjects will be treated with 1000 mg/m2 cytarabine intravenously every 12 hours on Days 1-3 of each consolidation cycle. Subjects will receive up to four consolidation cycles.

Also known as: Cytosar, cytosine arabinoside, Ara-C

Prospective HiDAC Treatment (HiDAC 123)

Eligibility Criteria

• Age: 61 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Allison Allegra
• Organization: University of Florida

allisonallegra3@ufl.edu

352-294-5691

Study Officials

• Jack Hsu, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 4, 2021
• Study Start: March 8, 2022
• Primary Completion: January 12, 2024
• Study Completion: August 26, 2024
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Locations

US (1)