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Monoclonal Antibodies

Daunorubicin-Cytarabine + Gemtuzumab for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Yesid Alvarado-Valero, MD
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
Patients with post-hypomethylating agent (post-HMA) failure high-risk myelodysplastic syndrome (MDS), as defined by the presence of > 10% blasts, are also eligible
Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights

Study Summary

This trial is studying the side effects and effectiveness of two drugs, liposome-encapsulated daunorubicin-cytarabine and gemtuzumab ozogamicin, in treating patients with relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndrome.

Who is the study for?
This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome, who are CD33 positive and have an ECOG performance status of <=2. They must not be pregnant, agree to use contraception, and have acceptable liver and kidney function. Excluded are those with significant CNS issues, uncontrolled infections, recent transplants with GvHD, prior extensive anthracycline treatment (>200 mg/m^2), active hepatitis B/C or HIV.Check my eligibility
What is being tested?
The trial tests a combination of liposome-encapsulated daunorubicin-cytarabine (a chemotherapy drug) and gemtuzumab ozogamicin (an antibody linked to a toxin targeting cancer cells). It aims to see how well these drugs treat patients whose AML has returned after treatment or doesn't respond at all.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the monoclonal antibody component of gemtuzumab ozogamicin, as well as typical chemotherapy-related effects such as nausea, fatigue, increased risk of infection due to low blood cell counts, liver toxicity and potential heart damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My high-risk MDS worsened after hypomethylating treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I am a woman who cannot become pregnant due to menopause or surgery.
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My leukemia is CD33 positive and has come back or didn't respond to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 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
Incidence and severity of all adverse events assessed using Common Toxicity Criteria version 4.0
Overall response rate
Secondary outcome measures
Demographic/clinical characteristics (i.e. duration of response) and safety data of the patients
Event-free survival
Overall survival
+1 more

Side effects data

From 2020 Phase 2 trial • 56 Patients • NCT02286726
25%
Febrile Neutropenia
21%
Neutropenic Fever
17%
Lung Infection
17%
Sepsis
13%
Insomnia
8%
Pericardial Effusion
8%
Infection
8%
Hypertension
4%
Cardiac Disorders
4%
Fever
4%
Intracranial Hemorrhage
4%
Pancreatitis
4%
Pleural Effusion
4%
Joint Effusion
4%
Alanine aminotransferase Increase
4%
Anxiety
4%
Blood Bilirubin Increase
4%
Acute Coronary Syndrome
4%
Respiratory Failure
4%
Multi-Organ Failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
Arm III (Standard-dose (100 Units/m^2) CPX-351)
Arm I (Lower-dose (50 Units/m^2) CPX-351)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CPX-351, gemtuzumab ozogamicin)Experimental Treatment3 Interventions
INDUCTION CYCLE: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 of cycle 1 and days 1 and 3 of cycle 2 and gemtuzumab ozogamicin IV over 120 minutes on day 1. Treatment repeats every 28 days for up to 2 cycles in the absence of unacceptable toxicity. CONSOLIDATION CYCLE: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 and gemtuzumab ozogamicin over 120 minutes on day 1. Treatment repeats every 28 days for up to 2 cycles in the absence of unacceptable toxicity. MAINTENANCE CYCLE: Patients receive gemtuzumab ozogamicin IV over 120 minutes on day 1. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,291 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,315 Total Patients Enrolled
Yesid Alvarado-Valero, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Gemtuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03672539 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (CPX-351, gemtuzumab ozogamicin)
Acute Myeloid Leukemia Clinical Trial 2023: Gemtuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT03672539 — Phase 2
Gemtuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03672539 — Phase 2

Frequently Asked Questions

~12 spots leftby Nov 2025