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Chemotherapy
Chemotherapy + Enzyme Inhibitors for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Gina Keiffer, MD
Research Sponsored by Thomas Jefferson University
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 1 year
Awards & highlights
Study Summary
This trial tests if giving chemotherapy drugs with enzyme inhibitors can help treat AML.
Who is the study for?
This trial is for adults (18+) with acute myeloid leukemia that has relapsed or is refractory, having failed at least one prior therapy. Participants must be able to take oral medication, have a certain level of kidney function (CrCL >= 45), and an ECOG performance status of 2 or less. They should not be pregnant/breastfeeding, have active second cancers except some exceptions, severe diseases, known allergies to study drugs, CNS leukemia involvement, or conditions affecting study compliance.Check my eligibility
What is being tested?
The trial tests the safety and optimal doses of palbociclib or tazemetostat combined with CPX-351 chemotherapy in AML patients. CPX-351 includes daunorubicin and cytarabine which are standard treatments for AML. Palbociclib and tazemetostat are enzyme inhibitors approved for other cancers but not yet for AML; they may help stop cancer cell growth by blocking necessary enzymes.See study design
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss (alopecia), blood disorders like low counts leading to increased infection risk. Enzyme inhibitors can cause issues like diarrhea and liver function changes. Specific reactions depend on individual tolerance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade >= 3 non-hematologic dose limiting toxicities
Secondary outcome measures
Complete response
Incidence of adverse events
Induction failure/refractory acute myeloid leukemia (AML)
+7 moreOther outcome measures
Deoxyribonucleic acid (DNA) damage and apoptosis
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part II (palbociclib, CPX-351)Experimental Treatment4 Interventions
Patients receive palbociclib PO QD on days -3 to -1, and CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients also undergo bone marrow aspiration and biopsy and blood sample collection during screening and on study.
Group II: Part I (tazemetostat, CPX-351)Experimental Treatment4 Interventions
Patients receive tazemetostat PO BID on days -1 to 6, and CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients also undergo bone marrow aspiration and biopsy and blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~780
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Biospecimen Collection
2004
Completed Phase 2
~1700
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,415 Total Patients Enrolled
Gina Keiffer, MDPrincipal InvestigatorThomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no active cancer except for certain skin, cervical, or low-grade prostate cancers.I am willing and able to follow all study rules and attend all appointments.I am 18 years old or older.I can do most of my daily activities on my own.My heart condition is stable and my heartbeat rhythm is controlled.I have recovered from side effects of my previous treatment, except for hair loss.I have been diagnosed with acute promyelocytic leukemia.I have not exceeded the safe limit for daunorubicin or had high-dose chest radiation.I do not have active brain leukemia, or if I do, it's without neurological symptoms.I can take pills by mouth.I am of childbearing age and my pregnancy test is negative.I've had experimental treatments, but not within the last 2 weeks and any side effects are mild.I am not taking any growth factors except for erythropoietin.My leukemia has returned or didn't respond to treatment, and I've had a recent bone marrow test.I am not on chemotherapy, except possibly for hydroxyurea, methotrexate, or cytarabine.I do not have any severe illnesses that would prevent me from receiving strong treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Part I (tazemetostat, CPX-351)
- Group 2: Part II (palbociclib, CPX-351)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research project currently enrolling participants?
"According to the information published on clinicaltrials.gov, this specific medical trial is not presently recruiting patients. The study was first posted in November 1st 2022 and its most recent update occurred on 16th of that same month. However, 1467 other trials are still open for participants at this time."
Answered by AI
Is the prescription of palbociclib, tazemetostat, and CPX-351 safe for humans?
"As this is a Phase 1 trial, with limited evidence to support both safety and efficacy, our team at Power has assigned Treatment (palbociclib, tazemetostat, CPX-351) a rating of one on the risk scale."
Answered by AI
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