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MCL-1 Inhibitor
PRT1419 + Azacitidine/Venetoclax for Leukemia and Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Prelude Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Refractory/relapsed disease, having progressed on prior treatment, and without access to further approved therapies or ineligible for approved therapies, in one of the following disease categories: AML, CMML, MDS, MDS/MPN Overlap Syndrome, CLL/SLL, and B-cell NHLs
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately 3.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what dose is safe and how well it works.
Who is the study for?
This trial is for adults with certain relapsed/refractory myeloid or B-cell blood cancers, including AML, CMML, MDS, CLL/SLL, and B-cell NHLs. Participants must have an ECOG score of 0-2 (which measures their ability to perform daily activities), proper organ function, and no access to other approved treatments. They can't join if they've had recent heart issues, uncontrolled illnesses like high blood pressure or unstable brain metastases; prior treatment with MCL-1 inhibitors; or certain other medical conditions.Check my eligibility
What is being tested?
The study tests PRT1419 alone or combined with Azacitidine/Venetoclax in patients whose cancer has returned after treatment. It's a Phase 1 trial aiming to find the safest dose that works best without causing too many side effects (dose-limiting toxicities). Researchers will gradually increase doses for new groups of patients until they determine the maximum tolerated dose.See study design
What are the potential side effects?
Potential side effects include those common to cancer drugs such as nausea, fatigue, risk of infection due to low blood cell counts. Specific risks related to PRT1419 aren't detailed but may involve symptoms affecting different organs depending on how it interacts with Azacitidine/Venetoclax.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a type of cancer called AML, CMML, MDS, MDS/MPN Overlap Syndrome, CLL/SLL, or B-cell NHLs, and your disease has come back or hasn't responded to previous treatments. You don't have access to any other approved treatments or you're not eligible for them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through approximately 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through approximately 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLT) of PRT1419
Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) and schedule of PRT1419
Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments
Secondary outcome measures
Anti-tumor activity of PRT1419 monotherapy and in combination with AZA and VEN: Duration of response (DOR)
Anti-tumor activity of PRT1419 monotherapy and in combination with AZA and VEN: Overall response rate (ORR)
Anti-tumor activity of PRT1419 monotherapy and in combination with AZA and VEN: Overall survival (OS)
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: PRT1419/Venetoclax CombinationExperimental Treatment2 Interventions
PRT1419 will be administered by intravenous infusion once weekly on a 28-day treatment cycle at the dose level assigned and Venetoclax will be administered orally after either a 3-day or 5-week ramp-up period to reach 400 mg daily administration, prior to commencing PRT1419 administration.
Group II: PRT1419/Azacitidine CombinationExperimental Treatment2 Interventions
PRT1419 will be administered by intravenous infusion once weekly on a 28-day treatment cycle at the dose level assigned and Azacitidine will be administered by intravenous or subcutaneous on Days 1 through 7 (or alternatively on Days 1 through 5, 8 and 9) of each 28-day treatment cycle.
Group III: PRT1419 MonotherapyExperimental Treatment1 Intervention
PRT1419 will be administered by intravenous infusion once weekly on a 28-day treatment cycle at the dose level assigned.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990
PRT1419
2020
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Prelude TherapeuticsLead Sponsor
8 Previous Clinical Trials
634 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a stem-cell transplant or have a condition called graft-versus-host disease (GVHD) with a severity level higher than 1 within the past 90 days.You previously had another type of cancer that was successfully treated and hasn't come back for at least 2 years before joining the study.You have had a stroke or mini-stroke in the past six months. If you have had a blood clot in your lungs, you should not have any symptoms when you join the study.You have had another type of cancer in the past, except for the following:You are taking certain medications that could interact with the study drugs, or there are specific medications that you cannot take together with the study drugs.You have an ongoing inflammatory disorder in your digestive system or have had bariatric surgery that may affect how your body absorbs nutrients.You have a type of cancer called AML, CMML, MDS, MDS/MPN Overlap Syndrome, CLL/SLL, or B-cell NHLs, and your disease has come back or hasn't responded to previous treatments. You don't have access to any other approved treatments or you're not eligible for them.You have had non-melanoma skin cancer or lentigo maligna that has been effectively treated and there is no current sign of the disease.
Research Study Groups:
This trial has the following groups:- Group 1: PRT1419 Monotherapy
- Group 2: PRT1419/Azacitidine Combination
- Group 3: PRT1419/Venetoclax Combination
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.
What are the venues in which this trial can be accessed?
"For the time being, 8 sites are running this clinical trial; Houston, Philadelphia and Orange City among them. To reduce commuting requirements if accepted into the study, applicants should prioritize selecting a nearby site."
Answered by AI
How many participants are currently taking part in this clinical trial?
"Affirmative. Per the information found on clinicaltrials.gov, this medical trial opened to recruitment on March 22nd 2022 and was most recently updated in October 31st of that same year. 30 participants are required across 8 distinct sites."
Answered by AI
Is this trial accepting new participants presently?
"According to information found on clinicaltrials.gov, this trial is actively enrolling patients at present. It was posted online for the first time on March 22nd 2022 and its details were recently updated in October of the same year."
Answered by AI
Can a person expect any adverse effects from taking PRT1419?
"Considering the limited evidence of PRT1419's efficacy and safety, our team has assigned it a score of 1."
Answered by AI
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