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Antimetabolite

Atovaquone + Chemotherapy for Acute Myeloid Leukemia (ATACC AML Trial)

Q: How many participants are involved in this research project?

Sadly, this study is no longer actively recruiting participants. It was first advertised on July 10th 2018 and the most recent update to its information was October 7th 2022. However, those seeking alternate studies may find solace in knowing that there are currently 1,535 clinical trials searching for <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> patients and 515 research projects looking for Cytarabine users.

Q: Are there past investigations involving Cytarabine?

Currently, there are 515 registered clinical trials studying the effects of Cytarabine with 135 located in Phase 3. While Seattle is a major hub for this research, it's being conducted at 23380 sites around the world.

Q: Is it possible to be enrolled in this experiment?

To be selected for this medical trial, potential participants must have myeloid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> and fall within the age range of 1 month to 20 years old. Around 26 individuals are being accepted in total.

Q: Does this study have any age restrictions?

This medical study seeks participants aged between 30 days and 20 years old. 638 trials are available for those under 18, while 1570 studies have been developed to serve individuals in the senior demographic.

Q: What illnesses has Cytarabine been successful in alleviating?

Cytarabine can be beneficial for patients suffering from meningeal <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>, and <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> (<a href="https://www.withpower.com/clinical-trials/sclc">SCLC</a>).

Q: Is it still possible to join this research initiative?

This study is not currently accepting participants. The trial was initially published on July 10th, 2018 and last modified October 7th 2022. If you are seeking other trials, there are 1535 studies recruiting patients with <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> or myeloid conditions and 515 involving Cytarabine therapy that have open enrollment at the present moment.

Phase < 1

Waitlist Available

Led By Alexandra Stevens, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Patients with previously untreated primary AML who meet the customary criteria for AML with ≥ 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO) Myeloid Neoplasm Classification are eligible

Patients with a history of myelodysplastic syndrome that has progressed to AML which meets the criteria above are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

ATACC AML Trial Summary

This trial will test if a daily dose of atovaquone, combined with standard chemotherapy for AML, is safe and effective.

Who is the study for?

This trial is for children over 1 month and young adults under 21 with newly diagnosed acute myeloid leukemia (AML) that hasn't been treated before. They must have specific genetic abnormalities or a certain percentage of bone marrow blasts, among other criteria. Those who've had extensive prior anthracycline treatment, are pregnant or breastfeeding, or have certain genetic conditions like Fanconi anemia aren't eligible.Check my eligibility

What is being tested?

The study tests atovaquone combined with standard chemotherapy drugs (Daunorubicin, Gemtuzumab Ozogamicin, Etoposide, Cytarabine) in treating new cases of AML. It aims to see how often atovaquone doses are missed due to chemo side effects and measure the levels and timing of atovaquone in the blood during treatment.See study design

What are the potential side effects?

Possible side effects include those from standard chemotherapy such as nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts; plus any specific reactions to atovaquone which could be digestive issues or rashes.

ATACC AML Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have AML with more than 20% bone marrow blasts, as per WHO guidelines.

Select...

My myelodysplastic syndrome has progressed to acute myeloid leukemia.

Select...

I have been recently diagnosed with acute myelogenous leukemia.

Select...

I can take medicine by mouth or feeding tube.

ATACC AML Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose Omission Frequency

Plasma Concentrations

Time to Achieve Steady State

ATACC AML Trial Design

2Treatment groups

Experimental Treatment

Group I: DA 3+10 with GO plus AQExperimental Treatment4 Interventions

Induction I DA: daunorubicin, cytarabine 3+10 with GO: gemtuzumab ozogamicin, atovaquone daily

Group II: ADE 10+3+5 plus Atovaquone (AQ)Experimental Treatment4 Interventions

Induction I ADE: cytarabine, daunorubicin, etoposide 10+3+5, atovaquone daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atovaquone

2012

Completed Phase 1

~80

Etoposide

2010

Completed Phase 3

~2440

Daunorubicin

2013

Completed Phase 4

~4940

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~440

Cytarabine

2016

Completed Phase 3

~3310

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

William Marsh Rice UniversityOTHER

45 Previous Clinical Trials

27,827 Total Patients Enrolled

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,926 Total Patients Enrolled

Alexandra Stevens, MDPrincipal InvestigatorBaylor College of Medicine - Texas Children's Hospital

Media Library

Cytarabine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT03568994 — Phase < 1

Acute Myeloid Leukemia Research Study Groups: ADE 10+3+5 plus Atovaquone (AQ), DA 3+10 with GO plus AQ

Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT03568994 — Phase < 1

Cytarabine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03568994 — Phase < 1

Frequently Asked Questions

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

How many participants are involved in this research project?

"Sadly, this study is no longer actively recruiting participants. It was first advertised on July 10th 2018 and the most recent update to its information was October 7th 2022. However, those seeking alternate studies may find solace in knowing that there are currently 1,535 clinical trials searching for leukemia patients and 515 research projects looking for Cytarabine users."

Answered by AI

Are there past investigations involving Cytarabine?

"Currently, there are 515 registered clinical trials studying the effects of Cytarabine with 135 located in Phase 3. While Seattle is a major hub for this research, it's being conducted at 23380 sites around the world."

Answered by AI

Is it possible to be enrolled in this experiment?

"To be selected for this medical trial, potential participants must have myeloid leukemia and fall within the age range of 1 month to 20 years old. Around 26 individuals are being accepted in total."

Answered by AI

Does this study have any age restrictions?

"This medical study seeks participants aged between 30 days and 20 years old. 638 trials are available for those under 18, while 1570 studies have been developed to serve individuals in the senior demographic."

Answered by AI

What illnesses has Cytarabine been successful in alleviating?

"Cytarabine can be beneficial for patients suffering from meningeal leukemia, prostate cancer, and small cell lung cancer (SCLC)."

Answered by AI

Is it still possible to join this research initiative?

"This study is not currently accepting participants. The trial was initially published on July 10th, 2018 and last modified October 7th 2022. If you are seeking other trials, there are 1535 studies recruiting patients with leukemia or myeloid conditions and 515 involving Cytarabine therapy that have open enrollment at the present moment."

Answered by AI

Recent research and studies

Current Oncology ReportsJournal

Acute Myeloid Leukemia in Children: Emerging Paradigms in Genetics and New Approaches to Therapy

Conneely, Shannon E., and Alexandra M. Stevens. 2021. “Acute Myeloid Leukemia in Children: Emerging Paradigms in Genetics and New Approaches to Therapy”. Current Oncology Reports. Springer Science and Business Media LLC. doi:10.1007/s11912-020-01009-3.

clinicaltrials.govStudy

Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML)

Alexandra Stevens 2018. "Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03568994.

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