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Anti-metabolites

Chemotherapy for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Joseph M Scandura

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of acute myeloid leukemia (AML) as defined by the World Health Organization

Molecular AML-risk group is less-than-favorable as defined by specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from cr documentation to either aml relapse, assessed up to 10 years

Awards & highlights

Study Summary

This trial is testing two doses of decitabine given with daunorubicin hydrochloride and cytarabine to see how well it works in treating patients with acute myeloid leukemia.

Who is the study for?

This trial is for adults with acute myeloid leukemia (AML) who don't have favorable-risk genetic mutations and are in good physical condition. They must not be pregnant, agree to use birth control, and cannot have had certain treatments recently or a high lifetime dose of similar chemotherapy drugs. People with uncontrolled illnesses, HIV with low CD4 counts, or serious heart conditions can't join.Check my eligibility

What is being tested?

The study tests how well decitabine works alongside daunorubicin hydrochloride and cytarabine in AML treatment. It compares the effectiveness of low-dose versus high-dose decitabine when combined with these chemotherapy drugs to see if it makes cancer cells more sensitive to treatment.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system, blood cell counts changes leading to increased infection risk or bleeding problems, nausea, vomiting, liver function alterations, fatigue and potential heart complications due to the nature of chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with acute myeloid leukemia.

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My AML is classified as high-risk based on its genetics.

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I do not have a specific type of leukemia known as APL.

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I can take care of myself but might not be able to do heavy physical work.

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My heart is functioning well, as confirmed by a heart scan.

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My kidney function is normal or only slightly impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from cr documentation to either aml relapse, assessed up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from cr documentation to either aml relapse, assessed up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from cr documentation to either aml relapse, assessed up to 10 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Complete remission rate (CR1)

Secondary outcome measures

Complete remission rate (CR1 + CR2)

Event-free survival

Overall survival

+3 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

65%

Infusion related reaction

59%

Neutrophil count decreased

41%

Upper respiratory infection

29%

Aspartate aminotransferase increased

29%

Platelet count decreased

24%

Alanine aminotransferase increased

18%

Sinusitis

18%

Urinary tract infection

12%

Tooth infection

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 and MTD (800 mg Entospletinib Daily)

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (decitabine, daunorubicin hydrochloride, cytarabine)Experimental Treatment5 Interventions

Patients receive decitabine IV over 1 hour on days -5 to -1. Patients then receive induction chemotherapy as in arm I in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course.

Group II: Arm I (daunorubicin hydrochloride, cytarabine)Experimental Treatment4 Interventions

Patients receive induction chemotherapy comprising daunorubicin hydrochloride IV daily on days 1-3 and cytarabine IV continuously on days 1-7 in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR after the first induction-chemotherapy course receive a second identical induction course.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

FDA approved

Decitabine

FDA approved

Daunorubicin

FDA approved

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,975 Total Patients Enrolled

Joseph M ScanduraPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01627041 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Arm II (decitabine, daunorubicin hydrochloride, cytarabine), Arm I (daunorubicin hydrochloride, cytarabine)

Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT01627041 — Phase 2

Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01627041 — Phase 2

Frequently Asked Questions

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

How many individuals have been enlisted to take part in this clinical experiment?

"This clinical trial is no longer accepting participants; the original posting was on September 16th of 2011 while the last update occurred in June 18th of 2021. In contrast, there are 1,536 studies recruiting people with leukemia and myeloid disorders as well as 345 studies currently searching for volunteers to partake in pharmacological trials."

Answered by AI

Is there still availability for participants in this investigation?

"Unfortunately, this medical trial has ceased its patient recruitment. This investigation started on September 16th 2011 and was last updated on June 18th 2021. However, there are 1536 studies looking to enrol patients with leukemia or myeloid disorders as well as 345 trials exploring the pharmacological aspects of various treatments that are currently open for participation."

Answered by AI

What prior experiments have been conducted to evaluate the efficacy of this pharmacological treatment?

"Presently, 345 clinical trials are ongoing for pharmacological study. Of those, a notable 76 have progressed to the third phase of testing. Most of these studies occur in New york City; however, there exist 12,943 sites administering this medication as part of their research."

Answered by AI

What are the usual applications of Pharmacological Study?

"ipss risk category intermediate-2 can benefit from the implementation of Pharmacological Study. Furthermore, this treatment has also been proven to be beneficial for multiple anemias, leukemias, and myelocytic conditions such as acute or blast phase chronic myelocytic leukemia."

Answered by AI

What risks do participants in the Pharmacological Study face?

"Although Phase 2 trials have yet to prove efficacy, the safety of this particular pharmacological study was evaluated as a score of two."

Answered by AI

Are applicants of this trial who are less than 85 years old qualified to participate?

"To be admitted into this clinical trial, patients must fall within the 18-65 age bracket. There are a total of 550 studies for those younger than 18 and 1480 dedicated to seniors over 65 years old."

Answered by AI

How extensive is the geographical reach of this research endeavor?

"Nine medical centres are currently looking to enroll patients in this trial, including Memorial Sloan Kettering Cancer Center (New york), Roswell Park Cancer Institute (Buffalo) and NYP/Weill Cornell Medical Center (Cleveland). Additionally, a number of other locations have been identified."

Answered by AI

Are there any specific demographics that should be prioritized for this clinical research?

"This medical trial is seeking 178 individuals with a diagnosis of acute myeloid leukemia (AML) between the age range 18-65. Prospective patients must meet all of the following criteria: No evidence of certain fusion transcripts, Negative for specific chromosomal abnormalities identified by metaphase karyotyping and fluorescent in situ hybridization, Not diagnosed with APL/FAB M3 subtype, Maximum ECOG Performance Status score 2 (Karnofsky ≥ 60%), Normal ejection fraction based on echocardiogram or multi gated acquisition scan results, AST/ALT ≤ 2.5x institutional ULN; Serum"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia

2011. "Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01627041.

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