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Anti-metabolites

Pharmacological Study for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Led By Todd M Cooper

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat relapsed or refractory acute myeloid leukemia in young patients. The new combination includes liposome-encapsulated daunorubicin-cytarabine, fludarabine phosphate, cytarabine, and filgrastim. This trial will test the side effects of the new combination and find the best dose.

Eligible Conditions

Childhood Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants With a Dose-limiting Toxicity

Percentage of Responders (Complete Response or Complete Remission With Partial Platelet Recovery) After up to 2 Cycles

Secondary outcome measures

Liposome-encapsulated Cytarabine Area Under the Curve

Liposome-encapsulated Cytarabine Clearance

Liposome-encapsulated Cytarabine Time of Maximum Concentration

+6 more

Other outcome measures

Change in High Sensitive C-reactive Protein (HS-CRP) Levels

Change in Micro Ribonucleic Acid (miRNA) Using TaqMan miRNA Assays

Change in N-terminal Pro B-type Natriuretic Peptide (NT-BNP) Levels

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CPX-351 and FLAG)Experimental Treatment6 Interventions

COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2. COURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Filgrastim

2000

Completed Phase 3

~3670

Liposome-encapsulated Daunorubicin-Cytarabine

2016

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,902 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,816 Total Patients Enrolled

Todd M CooperPrincipal InvestigatorChildren's Oncology Group

2 Previous Clinical Trials

2,360 Total Patients Enrolled

Frequently Asked Questions

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

Does this clinical trial accept those who are of advanced age?

"According to the criterion for acceptance, this study is open to patients aged one year and up to twenty-one years old."

Answered by AI

To what extent have other scientific trials investigated Pharmacological Study?

"Currently, 687 clinical studies for the pharmacologic treatment are ongoing. Out of those trials, 100 have advanced to Phase 3 testing. Saint Louis is home to a majority of these experiments; however, there exist 17728 other locations running related tests as well."

Answered by AI

In what scenarios is Pharmacological Study typically prescribed?

"Pharmacological Study is commonly prescribed as an intervention for infection, but also proves effective in treating a range of conditions such as meningeal leukemia, mobilization of hematopoietic stem cells therapy and acute myelocytic leukaemia."

Answered by AI

How many healthcare facilities are performing this research experiment?

"This study is recruiting patients from multiple sites, including Children's Mercy Hospitals and Clinics in Kansas City, Missouri; University of Vermont and State Agricultural College in Burlington, Vermont; Mercy Hospital Saint Louis in Saint Louis, Nebraska; as well as a further 73 locations."

Answered by AI

Are there any openings available in this clinical trial?

"Per the information on clinicaltrials.gov, recruitment for this medical trial has been closed; it was initially posted in April 2016 and last updated in January 2022. Despite that, 2152 other trials are actively recruiting patients currently."

Answered by AI

Am I eligible to join this experimental research endeavor?

"The requirements for enrolment in this medical trial include a diagnosis of leukemia and being between 1 year old and 21. Approximately 38 participants are desired to be included."

Answered by AI

How many participants have been invited to partake in this clinical examination?

"At present, this clinical trial is not taking on new participants. It was initially posted in April 2016 and the latest edition to its information occurred January 18th 2022. However, if one wishes to take part in a different trial then there are currently 1465 trials for leukemia patients still recruiting and 687 Pharmacological Study options that have yet to meet their participant quota."

Answered by AI

What is the central target of this research endeavor?

"This trial will assess the Number of Participants With a Dose-limiting Toxicity over an 8 week period. Secondary outcomes include Liposome-encapsulated Cytarabine Area Under the Curve, Liposome-encapsulated Daunorubicin Volume of Distribution, and Liposome-encapsulated Daunorubicin Time of Maximum Concentration for patients in the dose finding phase."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase I/II Study of CPX-351 Followed by Fludarabine, Cytarabine, and Granulocyte-colony Stimulating Factor for Children with Relapsed Acute Myeloid Leukemia: A Report from the Children’s Oncology Group

Cooper, Todd M., Michael J. Absalon, Todd A. Alonzo, Robert B. Gerbing, Kasey J. Leger, Betsy A. Hirsch, Jessica Pollard, Bassem I. Razzouk, Richard Aplenc, and E. Anders Kolb. 2020. “Phase I/II Study of CPX-351 Followed by Fludarabine, Cytarabine, and Granulocyte-colony Stimulating Factor for Children with Relapsed Acute Myeloid Leukemia: A Report from the Children’s Oncology Group”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.03306.

clinicaltrials.govStudy

Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

2016. "Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02642965.