← Back to Search

Monoclonal Antibodies

CPX-351 + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Caspian Oliai, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

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 up to 18 months

Awards & highlights

Study Summary

This trial is testing the combination of two drugs to treat patients with leukemia that has returned after being in remission. The first drug, CPX-351, is a chemotherapy that works in different ways to stop the growth of cancer cells. The second drug, gemtuzumab ozogamicin, is a monoclonal antibody that attaches to cancer cells in a targeted way and delivers chemotherapy to kill them. The trial is testing whether giving both drugs together is more effective than giving only one of the drugs.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose (MTD)

Secondary outcome measures

Diagnosis of veno-occlusive disease (VOD)

Duration of remission

Incidence of toxicities

+4 more

Other outcome measures

Exome sequencing analysis

Genotype at CD33 splicing single nucleotide polymorphism (SNP) RS12459419

Multidrug resistance activity of leukemia cell P-glycoprotein (Pgp)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CPX-351, gemtuzumab ozogamicin)Experimental Treatment2 Interventions

INDUCTION: Patients receive liposome-encapsulated daunorubicin 44mg/m2 - cytarabine 100mg/m2 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin 3 mg/m2 (max 4.5 mg) IV over 120 minutes on day 7, or days 4 and 7, or days 1, 4, and 7 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive consolidation therapy at the discretion of the treating physician and/or proceed to allogeneic HSCT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposome-encapsulated Daunorubicin-Cytarabine

2016

Completed Phase 2

~100

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,037 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,861 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

248 Previous Clinical Trials

34,346 Total Patients Enrolled

Media Library

Gemtuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03904251 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Treatment (CPX-351, gemtuzumab ozogamicin)

Acute Myeloid Leukemia Clinical Trial 2023: Gemtuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT03904251 — Phase 1

Gemtuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03904251 — Phase 1

Frequently Asked Questions

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

What are the safety implications of Liposome-encapsulated Daunorubicin-Cytarabine for patients?

"Due to the limited amount of data available, our team at Power gave Liposome-encapsulated Daunorubicin-Cytarabine a score of 1 on safety and efficacy."

Answered by AI

What maladies are Liposome-encapsulated Daunorubicin-Cytarabine known to ameliorate?

"Liposome-encapsulated Daunorubicin-Cytarabine is the usual course of treatment for acute myelocytic leukemia. Additionally, this medication may be beneficial in other contexts such as blast phase chronic myelocytic leukemia, lymphoma, and prophylaxis against meningeal leukemia."

Answered by AI

Has the efficacy of Liposome-encapsulated Daunorubicin-Cytarabine been tested through previous experiments?

"Currently, there are 273 active trials investigating Liposome-encapsulated Daunorubicin-Cytarabine; 66 of which have advanced to phase 3. Of the 12644 different sites conducting studies for this agent, many are situated in New york City."

Answered by AI

Is the recruitment phase of this experiment underway?

"Per the details on clinicaltrials.gov, this investigation is in its active recruitment stage. It was originally uploaded to the site back on July 18th 2019 and has since been updated as of May 10th 2022."

Answered by AI

How many research volunteers are involved in this clinical trial?

"Correct. The public information on clinicaltrials.gov confirms that the trial is actively searching for participants, having gone live July 18th 2019 and last updated May 10th 2022. 33 individuals need to be scouted from 5 distinct medical centres."

Answered by AI

In what locations can participants join this research endeavor?

"At present, there are 5 clinical trial sites for this research project. These can be found in Orange, San Diego and San Francisco plus 2 other cities. To reduce travelling expenses it is beneficial to select a trial near you if possible."

Answered by AI

Recent research and studies

Bone Marrow TransplantationJournal

ELN Risk Stratification and Outcomes in Secondary and Therapy-related AML Patients Consolidated with Allogeneic Stem Cell Transplantation

Jentzsch, Madlen, Juliane Grimm, Marius Bill, Dominic Brauer, Donata Backhaus, Karoline Goldmann, Julia Schulz, Dietger Niederwieser, Uwe Platzbecker, and Sebastian Schwind. 2020. “ELN Risk Stratification and Outcomes in Secondary and Therapy-related AML Patients Consolidated with Allogeneic Stem Cell Transplantation”. Bone Marrow Transplantation. Springer Science and Business Media LLC. doi:10.1038/s41409-020-01129-1.

clinicaltrials.govStudy

CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia

2019. "CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03904251.