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Liposomal Therapy

Ceramide NanoLiposome for Acute Myeloid Leukemia (KNAN2001 Trial)

Phase 1
Waitlist Available
Research Sponsored by Keystone Nano, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Refractory AML: Patients who fail to achieve a complete remission (CR) after one line of AML directed therapy.
Relapsed AML: Patients who achieved a complete remission (CR) with one or more prior lines of AML directed therapy but then developed a relapse of AML.
Must not have
Acute Promyelocytic Leukemia or AML with active central nervous system (CNS) involvement.
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months before registration, or psychiatric illness/social situations that would limit compliance with study requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 24 weeks, and up to 24 weeks afterwards (total of 48 weeks)
Awards & highlights

Summary

This trial tests if combining a new drug with existing cancer treatments can make them more effective.

Who is the study for?
This trial is for adults over 18 with Acute Myeloid Leukemia (AML) that didn't respond to initial treatment or came back after. They should be in fairly good health otherwise, able to follow the study plan, and not have had a stem cell transplant recently or other cancers within the last year.Check my eligibility
What is being tested?
The trial tests Ceramide NanoLiposome (Ceraxa), which might boost the effectiveness of standard cancer drugs against AML. Participants will receive CNL combined with conventional treatments to see if this improves outcomes.See study design
What are the potential side effects?
While specific side effects of CNL are not listed here, common ones from similar cancer therapies include nausea, fatigue, increased risk of infection due to low blood counts, liver issues, and potential heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My AML did not respond to the first treatment.
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My AML cancer returned after treatment.
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I am 18 or older with AML that has not responded to treatment or has come back.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My leukemia affects my brain or spinal cord.
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I do not have any severe illnesses that my current medications cannot control.
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I had a stem cell transplant and am currently experiencing complications or taking certain medications.
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I have an active Hepatitis B or C infection.
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My cancer is present outside the bone marrow.
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I do not have an active, uncontrolled HIV infection.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 24 weeks, and up to 24 weeks afterwards (total of 48 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 24 weeks, and up to 24 weeks afterwards (total of 48 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Response - Complete Response
Clinical Response - Complete Response with Incomplete Hematologic Recovery (CRi)
Clinical Response - Partial Remission
+11 more
Secondary outcome measures
Event Free Survival
Number of Patients with Grade 3 or 4 Adverse Events
Overall Response
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open Label Administration of Ceramide NanoLiposomeExperimental Treatment1 Intervention
Ceramide NanoLiposome will be administered by Intravenous Dosing twice per week in accordance with the protocol relative to dose escalation. There is no placebo group or arm of the study.

Find a Location

Who is running the clinical trial?

Keystone Nano, IncLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
University of VirginiaOTHER
761 Previous Clinical Trials
1,256,020 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,944 Previous Clinical Trials
589,733 Total Patients Enrolled
~6 spots leftby Sep 2024
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