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Anti-metabolites

Chemotherapy for Pediatric Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Branko Cuglievan
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status: Lansky >= 50 for patients who are =< 16 years old and Karnofsky >= 50% for patients who are > 16 years old
Newly diagnosed secondary AML or relapsed refractory acute myeloid leukemia by World Health Organization (WHO) criteria with >= 5% blasts in the bone marrow or peripheral blood
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights

Study Summary

This trial is testing a combination of three drugs to treat relapsed or refractory acute myeloid leukemia in children. The drugs work in different ways to kill tumor cells.

Who is the study for?
This trial is for pediatric patients up to 21 years old with relapsed or refractory acute myeloid leukemia (AML) that's CD33 positive. They should have a certain level of organ function, not be pregnant or breastfeeding, and agree to use effective contraception. Excluded are those with heart issues, high doses of prior chemotherapy, active infections, other cancers in the last few years except certain skin cancers or localized cancers.Check my eligibility
What is being tested?
The trial tests liposomal cytarabine and daunorubicin alongside gemtuzumab ozogamicin for AML in children who've had treatment fail before. It aims to find the best dose and monitor side effects by seeing how these drugs stop cancer cells from growing.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, liver problems due to toxicity from ozogamicin, lowered blood cell counts leading to increased infection risk or bleeding tendencies, nausea, vomiting and potential damage to heart muscle.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most activities but need help with some, regardless of my age.
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I have acute myeloid leukemia with at least 5% cancer cells in my blood or bone marrow.
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I am not pregnant and agree to use birth control.
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My child's cancer is more than 3% CD33 positive.
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I am 21 years old or younger.
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My child's blood disorder is turning into acute leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose
Secondary outcome measures
Duration of response
Event free survival
Objective response
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CPX-351, GO)Experimental Treatment2 Interventions
INDUCTION 1 (28 days): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and GO IV over 2 hours on day 1 in the absence of disease progression or unacceptable toxicity. INDUCTION 2: Patients who do not attain a defined clinical response after cycle Induction 1 receive CPX-351 IV on days 1 and 3 and GO IV over 2 hours on day 1 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Beginning 4 weeks after last induction, patients receive CPX-351 IV over 90 minutes on days 1 and 3 and GO IV over 2 hours on day 1 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemtuzumab ozogamicin
FDA approved
Cytarabine
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,985 Previous Clinical Trials
1,789,099 Total Patients Enrolled
Branko CuglievanPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Cytarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04915612 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Treatment (CPX-351, GO)
Acute Myelogenous Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT04915612 — Phase 1
Cytarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04915612 — Phase 1

Frequently Asked Questions

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

How innocuous is Gemtuzumab Ozogamicin to the general public?

"The safety of Gemtuzumab Ozogamicin was rated 1 on a scale of 1 to 3 as this is an early phase trial, with limited evidence supporting its efficacy and safety."

Answered by AI

Is recruitment still open for participation in this project?

"According to clinicaltrials.gov, this research is currently open for recruitment; it was initially posted on May 21st of 2021 and recently modified on October 27th of 2022."

Answered by AI

What other examinations have been conducted in regards to Gemtuzumab Ozogamicin?

"Presently, there are 273 ongoing investigations for Gemtuzumab Ozogamicin with 66 trials in their third and final stage. Many of these studies take place within the Big Apple itself; however, 12644 sites around the world have been identified as conducting research involving this medication."

Answered by AI

What is the uppermost limit for participants in this clinical investigation?

"Affirmative, according to clinicaltrials.gov's records, this trial is actively recruiting participants as of October 27th 2022 - the last time it was updated. The study first appeared on May 21st 2021 and requires 18 patients from a single location."

Answered by AI

What are the typically reported applications of Gemtuzumab Ozogamicin?

"Gemtuzumab Ozogamicin is frequently utilized to treat acute myelocytic leukemia and its blast phase chronic variant. Additionally, it can be employed for lymphoma treatment or prophylactic defence against meningeal leukemia."

Answered by AI

What objectives is this scientific inquiry seeking to accomplish?

"This trial is designed to identify the maximum tolerable dose of a given medication over a period of 28 days. Secondary outcomes will be assessed through descriptive statistics and Kaplan-Meier analysis, including duration of response, objective response, and overall survival."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia
2021. "Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04915612.
~4 spots leftby May 2025
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