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Trial record 1 of 1 for:    NCT04914676
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Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

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ClinicalTrials.gov Identifier: NCT04914676
Recruitment Status : Recruiting
First Posted : June 4, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
University of Florida

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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Cytarabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) in Complete Remission
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : August 2026


Arm Intervention/treatment
Experimental: Prospective HiDAC Treatment (HiDAC 123)
Subject on this arm will be treated with HiDAC prospectively.
Drug: Cytarabine
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.
Other Names:
  • Cytosar
  • cytosine arabinoside
  • Ara-C

Historical HiDAC Treatment (HiDAC 135)
Subjects on this arm will be historical controls who have previously received treatment with HiDAC.
Drug: Cytarabine
Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles.
Other Names:
  • Cytosar
  • cytosine arabinoside
  • Ara-C




Primary Outcome Measures :
  1. Duration of neutropenia [ Time Frame: 5 months ]
    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.


Secondary Outcome Measures :
  1. Duration of thrombocytopenia [ Time Frame: 5 months ]
    Determine the duration of thrombocytopenia in older patients with de novo AML after consolidation chemotherapy with HiDAC 123, as compared to historical controls treated with HiDAC 135.

  2. Incidence of documented infections [ Time Frame: 5 months ]
    Compare the incidence of documented infections (bloodstream infection, pneumonia, invasive fungal infection, Clostridium difficile infection, typhlitis, and febrile neutropenia) in patients receiving HiDAC 123 and HiDAC 135.

  3. Number of transfusions [ Time Frame: 4 months ]
    Compare the number of red blood cell and platelet transfusions per cycle in patients receiving HiDAC 123 and HiDAC 135.

  4. Readmission rates and length of readmission stay [ Time Frame: 5 months ]
    Compare the incidence of readmission and the length of readmission stay in patients receiving HiDAC 123 and HiDAC 135.

  5. Non-hematologic toxicities [ Time Frame: 5 months ]
    Compare the differences in non-hematologic toxicities in patients receiving HiDAC 123 and HiDAC 135.

  6. Time to next treatment [ Time Frame: 5 months ]
    Compare the time to next treatment (next chemotherapy cycle, transplant, etc.) in patients receiving HiDAC 123 and HiDAC 135.



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Ages Eligible for Study:   61 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914676


Contacts
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Contact: Abigail Masterson (352) 294-8322 PMO@cancer.ufl.edu
Contact: Erin Monari, PhD (352) 273-8128 PMO@cancer.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Christina Cline    352-273-6840    clcline@ufl.edu   
Principal Investigator: Jack Hsu, MD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Jack Hsu, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04914676    
Other Study ID Numbers: UF-HEM-009
IRB202003214 ( Other Identifier: University of Florida )
OCR40160 ( Other Identifier: University of Florida )
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Florida:
acute myeloid leukemia
high dose cytarabine
HiDAC
consolidation
chemotherapy schedule
bone marrow
elderly
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs