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Accelerated Cytarabine Dosing for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Jack Hsu, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to receive HiDAC consolidation #1
Completed intensive induction chemotherapy and confirmed in complete remission #1
Must not have
Patients unable to provide informed consent for prospective arm
Age < 61 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights

Summary

This trial will compare the safety of two ways of giving the drug cytarabine to people 61 and older with a certain kind of leukemia.

Who is the study for?
This trial is for individuals aged 55 or older with a diagnosis of de novo acute myeloid leukemia (AML) who are in complete remission after induction chemotherapy. They must be able to receive high-dose cytarabine and have labs/clinic visits at UF Health Shands, or agree to telephone visits if they can't be followed on-site.
What is being tested?
The study tests the safety of an accelerated dose schedule of high-dose cytarabine given on days 1-3 each cycle versus the standard schedule on days 1, 3, and 5. It's open label and non-randomized, focusing on older patients with AML.
What are the potential side effects?
High-dose cytarabine may cause side effects such as fever, nausea, vomiting, diarrhea, mouth sores, liver problems (elevated liver enzymes), lung issues (difficulty breathing), nerve damage leading to different sensations like numbness or tingling in hands and feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for high-dose cytarabine treatment.
Select...
I finished my first round of strong chemotherapy and am now in complete remission.
Select...
I am 61 years old or older.
Select...
I have been diagnosed with a specific type of leukemia (not M3 AML) with a high number of abnormal cells.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and agree to the study's procedures and risks.
Select...
I am younger than 61 years old.
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I am taking, have taken, or will take a FLT3 inhibitor.
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I am taking, have taken, or will take an IDH1 or IDH2 inhibitor.
Select...
I need considerable assistance and medical care.
Select...
My condition is either secondary AML or CML in blast crisis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of neutropenia
Secondary study objectives
Duration of thrombocytopenia
Incidence of documented infections
Non-hematologic toxicities
+3 more

Side effects data

From undefined Phase 3 trial • 1734 Patients • NCT00025259
80%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Hypoxia
1%
Depression
1%
Hyponatremia
1%
Myalgia
1%
Immune system disorders - Other, specify
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prospective HiDAC Treatment (HiDAC 123)Experimental Treatment1 Intervention
Subject on this arm will be treated with HiDAC prospectively.
Group II: Historical HiDAC Treatment (HiDAC 135)Experimental Treatment1 Intervention
Subjects on this arm will be historical controls who have previously received treatment with HiDAC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3330

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,390 Total Patients Enrolled
Jack Hsu, MDPrincipal InvestigatorUniversity of Florida

Media Library

Acute Myeloid Leukemia Research Study Groups: Prospective HiDAC Treatment (HiDAC 123), Historical HiDAC Treatment (HiDAC 135)
Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT04914676 — Phase 2
~1 spots leftby Sep 2025
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