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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.
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

KNAN2001 Trial 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.

KNAN2001 Trial 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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My recent lab tests show my organs are functioning well.
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My white blood cell count is below 30,000/µL, or I am taking medication to lower it.
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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 have AML and may have been treated with agents like azacitidine or decitabine.
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I can take care of myself and am up and about more than half of my waking hours.

KNAN2001 Trial 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

KNAN2001 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
24 Total Patients Enrolled
University of VirginiaOTHER
753 Previous Clinical Trials
1,245,014 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,931 Previous Clinical Trials
597,671 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~12 spots leftby Sep 2024