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PRT1419 for Marginal Zone Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
American Oncology Partners of Maryland, PA, Bethesda, MDMarginal Zone Lymphoma+10 MorePRT1419 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see what dose is safe and how well it works.

Eligible Conditions
  • Non-Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myeloproliferative Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
CC-95251
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PRT2527

Study Objectives

5 Primary · 10 Secondary · Reporting Duration: Baseline through approximately 3.5 years

Baseline through Day 28
Dose limiting toxicities (DLT) of PRT1419
Year 5
Minimum safe and biologically-effective dose
Recommended phase 2 dose (RP2D) and schedule of PRT1419
Year 2
Anti-tumor activity of PRT1419: measurement of objective responses
Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) and schedule of PRT1419
Pharmacokinetic profile of PRT1419: maximum observed plasma concentration
Year 3
Safety and tolerability of PRT1419 in combination with AZA and VEN: AEs, SAEs, CTCAE assessments
Safety and tolerability of PRT1419: AEs, SAEs, CTCAE assessments
Year 5
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)
Anti-tumor activity of PRT1419 monotherapy and in combination with AZA and VEN: Progression-free survival (PFS)/event free survival (EFS)
Pharmacokinetic profile of PRT1419 monotherapy and in combination with AZA or VEN: Area under the curve
Pharmacokinetic profile of PRT1419 monotherapy and in combination with AZA or VEN: Time to maximal plasma concentration
Pharmacokinetic profile of PRT1419 monotherapy and in combination with AZA or VEN: maximum observed plasma concentration

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
CC-95251
1
H3B-8800
1
PRT2527

Trial Design

4 Treatment Groups

PRT1419/Venetoclax Combination
1 of 4
PRT1419 Monotherapy
1 of 4
PRT1419/Azacitidine Combination
1 of 4
PRT1419
1 of 4

Experimental Treatment

132 Total Participants · 4 Treatment Groups

Primary Treatment: PRT1419 · No Placebo Group · Phase 1

PRT1419/Venetoclax CombinationExperimental Group · 2 Interventions: Venetoclax, PRT1419 · Intervention Types: Drug, Drug
PRT1419 Monotherapy
Drug
Experimental Group · 1 Intervention: PRT1419 · Intervention Types: Drug
PRT1419/Azacitidine CombinationExperimental Group · 2 Interventions: Azacitidine, PRT1419 · Intervention Types: Drug, Drug
PRT1419
Drug
Experimental Group · 1 Intervention: PRT1419 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2100
Azacitidine
2012
Completed Phase 3
~1700
PRT1419
2020
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through approximately 3.5 years

Who is running the clinical trial?

Prelude TherapeuticsLead Sponsor
8 Previous Clinical Trials
637 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You had cancer in the past but it was treated and has not come back for at least 2 years before participating in this study.
You have a type of cancer that has come back or not responded to previous treatments, and there are no other approved treatments available for your type of cancer. This applies to specific types of blood cancers like AML, CLL/SLL, MDS, and B-cell NHLs.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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