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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

Must not have

Prior treatment with CPX-351 or gemtuzumab ozogamicin

Evidence of active cerebral/meningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with CPX-351 or gemtuzumab ozogamicin before.

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I have an active brain or spinal cord condition.

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I do not have severe heart issues like recent heart attacks or advanced heart failure.

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I have received more than 200 mg/m^2 of certain chemotherapy drugs.

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I do not have active hepatitis B or C, nor am I HIV positive.

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I have liver cirrhosis, serious liver disease, or I am actively abusing alcohol.

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I had a stem cell transplant less than 6 months ago or I am being treated for graft-versus-host disease.

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I do not have any ongoing serious infections.

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I am not pregnant or breastfeeding.

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I have a serious brain condition that is not under control.

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I am of childbearing age and not using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

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

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

Primary study objectives

Overall response rate

Secondary study objectives

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

Pericardial Effusion

Infection

Hypertension

Pleural Effusion

Pancreatitis

Intracranial Hemorrhage

Cardiac Disorders

Fever

Joint Effusion

Alanine aminotransferase Increase

Anxiety

Blood Bilirubin Increase

Acute Coronary Syndrome

Respiratory Failure

Multi-Organ Failure

100%

80%

60%

40%

20%

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)

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 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

~460

Liposome-encapsulated Daunorubicin-Cytarabine

2017

Completed Phase 2

~170