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Accelerated Cytarabine Dosing for Acute Myeloid Leukemia

Q: How can I sign up to participate in this research?

<p>Up to 58 patients that have myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, are over 61 years old and under 99, and have completed intensive induction chemotherapy can participate in this trial. To be eligible, participants must also be of either gender, in complete remission, willing to have regular follow-up visits or telephone calls, and provide written informed consent if they are on the prospective arm of the study. For subjects on the historical arm, there is a waiver of informed consent..</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of neutropenia

Secondary outcome measures

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

Blood and lymphatic system disorders - Other, specify

Lymphocyte count decreased

Catheter related infection

Dehydration

Abdominal pain

Mucositis oral

Vomiting

Anaphylaxis

Hypokalemia

Hypotension

Hypoxia

Immune system disorders - Other, specify

Depression

Hyponatremia

Myalgia

Dizziness

Constipation

Esophagitis

Ileus

Pain

Carbon monoxide diffusing capacity decreased

Hypoalbuminemia

Neuralgia

Peripheral sensory neuropathy

Dyspnea

Diarrhea

Typhlitis

Hyperglycemia

Headache

Seizure

Syncope

Nausea

Cardiac disorders - Other, specify

Hypophosphatemia

Bone pain

Peripheral motor neuropathy

Thromboembolic event

Hypertension

100%

80%

60%

40%

20%

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

~3310

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,691 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications is Cytarabine most commonly used for?

"Cytarabine is used to treat leptomeningeal metastases, acute promyelocytic leukemia, meningeal leukemia, and blast phase chronic myelocytic leukemia."

Answered by AI

Are there any potential dangers to taking Cytarabine?

"Cytarabine has some clinical data supporting its safety, but none for efficacy. This earned it a score of 2 on our 1-to-3 scale."

Answered by AI

Are patients currently being recruited for this research?

"Yes, this information is accurate. The trial in question was first posted on March 8th of this year and was updated on August 9th."

Answered by AI

Is this research project available to people who are over 50 years old?

"The age requirements to enroll in this trial are 61 to 99. There are 542 studies for people under the age of 18 and 1435 for patients over 65."

Answered by AI

How many participants are in this trial?

"That is correct. The clinicaltrials.gov website shows that this trial began recruitment on March 8th, 2022 and was updated as recently as August 9th, 2022. This study requires 58 volunteers at 1 location."

Answered by AI

Are there other instances where Cytarabine has been used in scientific research?

"Cytarabine is being trialed in 250 different medical studies, 62 of which are currently in Phase 3. New york City has the highest concentration of these trials, but there are 9868 locations worldwide where Cytarabine is being studied."

Answered by AI

How can I sign up to participate in this research?

"Up to 58 patients that have myeloid leukemia, are over 61 years old and under 99, and have completed intensive induction chemotherapy can participate in this trial. To be eligible, participants must also be of either gender, in complete remission, willing to have regular follow-up visits or telephone calls, and provide written informed consent if they are on the prospective arm of the study. For subjects on the historical arm, there is a waiver of informed consent.."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04914676.

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