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Monoclonal Antibodies

CPX-351 + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

San Francisco, CA

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

No Placebo-Only Group

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.

See full description

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Diagnosis of veno-occlusive disease (VOD)

Duration of remission

Incidence of toxicities

+4 more

Other study objectives

Exome sequencing analysis

Genotype at CD33 splicing single nucleotide polymorphism (SNP) RS12459419

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

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 2

~170

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~460