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Anti-tumor antibiotic

CPX-351 for Acute Myeloid Leukemia (CPX GO Trial)

Phase 1

Waitlist Available

Led By Ellen K Ritchie, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

CPX GO Trial Summary

This trial is testing a new combination therapy of CPX-351 and gemtuzumab ozogamicin (GO) to treat acute myeloid leukemia (AML) in patients who are ineligible for standard intensive induction chemotherapy. The goal is to establish the safety and feasibility of the combination and to assess its efficacy and impact on patients' quality of life.

Eligible Conditions

Acute Myeloid Leukemia

CPX GO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

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

Feasible dose of Gemtuzumab Ozogamicin (GO) in combination with CPX-351 (cytarabine:daunorubicin) in older subjects with AML

Secondary outcome measures

Assessment of Minimal Residual Disease (MRD) response in subjects treated with this combination using multiparameter flow cytometry and next generation sequencing.

Assessment of the relationship of cognitive function to outcome using the Blessed Orientation-Memory-Concentration Test

Assessment of the relationship of cognitive function to outcome using the Montreal Cognitive Assessment (MoCA).

+5 more

CPX GO Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment2 Interventions

CPX-351: Daunorubicin 44mg/m^2 and cytarabine 100mg/m^2 on Days 1, 3, and 5 (90 minute IV infusion) Gemtuzumab ozogamicin: 3mg/m^2 on Days 1, 4 and 7 (2 hour IV infusion)

Group II: Cohort BExperimental Treatment1 Intervention

CPX-351: Daunorubicin 44mg/m^2 and cytarabine 100mg/m^2 on Days 1, 3 and 5 (90 minute IV infusion) Gemtuzumab ozogamicin: 3mg/m^2 on Days 1, 4 (2 hour IV infusion)

Group III: Cohort AExperimental Treatment2 Interventions

CPX-351 : Daunorubicin 44mg/m^2 and cytarabine 100mg/m^2/day on Days 1,3 and 5 (90 minute IV infusion) Gemtuzumab ozogamicin: 3mg/m^2/day on Day 1 (2 hour IV infusion)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CPX-351

2022

Completed Phase 3

~1090

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,634 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

248 Previous Clinical Trials

34,348 Total Patients Enrolled

PfizerIndustry Sponsor

4,565 Previous Clinical Trials

10,908,080 Total Patients Enrolled

Frequently Asked Questions

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

Are researchers currently recruiting individuals for this experiment?

"This research trial is actively recruiting, as indicated on clinicaltrials.gov; with its posting taking place on August 23rd 2019 and the most recent update occurring on December 21st 2021."

Answered by AI

What is the aggregate patient count for this trial?

"Affirmative. The online listing on clinicaltrials.gov denotes that this experiment is actively looking for participants, which was initially posted on August 23rd 2019 and recently edited in December 2021. This study requires a total of 30 volunteers from one site."

Answered by AI

Has CPX-351 obtained regulatory authorization from the FDA?

"Our team at Power rated the safety of CPX-351 as 1 due to it being a Phase 1 trial, which indicates limited knowledge regarding its efficacy and safety."

Answered by AI

What precedent has been established with regards to CPX-351 trials?

"At present, 273 studies are actively being run for CPX-351, 66 of which have reached the third phase. Notably, 12644 medical centres across New york host trials for this drug."

Answered by AI

What medical conditions does CPX-351 most often help to alleviate?

"CPX-351 is widely prescribed for acute myelocytic leukemia and has demonstrated efficacy in the treatment of blast phase chronic myelocytic leukemia, lymphoma, and prophylaxis against meningeal leukemia."

Answered by AI

Recent research and studies

HematologyJournal

Acute Myeloid Leukemia

Stone, Richard M., Margaret R. O'Donnell, and Mikkael A. Sekeres. 2004. “Acute Myeloid Leukemia”. Hematology. American Society of Hematology. doi:10.1182/asheducation-2004.1.98.

CancerJournal

Results of Intensive Chemotherapy in 998 Patients Age 65 Years or Older with Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome:

Kantarjian, Hagop, Susan O'Brien, Jorge Cortes, Francis Giles, Stefan Faderl, Elias Jabbour, Guillermo Garcia-Manero, et al.. 2006. “Results of Intensive Chemotherapy in 998 Patients Age 65 Years or Older with Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome:”. Cancer. Wiley. doi:10.1002/cncr.21723.

Journal of Clinical OncologyJournal

Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia

Cheson, Bruce D., John M. Bennett, Kenneth J. Kopecky, Thomas Büchner, Cheryl L. Willman, Elihu H. Estey, Charles A. Schiffer, et al.. 2003. “Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2003.04.036.

BloodJournal