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Epigenetic Modulator

AZD4573 for Lymphoma

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants diagnosed with Peripheral T-cell Lymphoma, Classical Hodgkin Lymphoma, or with Eastern Cooperative Oncology Group performance status of ≤ 2
Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 (cycle length is 35 days), day 1 of weeks 1-3 and cycle 2 (cycle length is 21 days), day 1 and day 2
Awards & highlights

Study Summary

This trial is testing a new drug, AZD4573, to see if it works well against two types of cancer, PTCL and cHL. The first part of the study will test how well the drug works and what side effects it has. If the drug looks promising, a second part of the study will test it in more people.

Who is the study for?
This trial is for people with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) or Classical Hodgkin Lymphoma (cHL). They must have tried certain treatments before, like platinum agents or asparaginase for PTCL and at least two therapies including BV and anti-PD1 for cHL. Participants need measurable lymphoma lesions, good performance status, and proper organ function. Those with severe diseases, uncontrolled conditions, recent infections, HIV, other types of lymphomas not listed here, unresolved toxicities from past treatments (except hair loss and neuropathy), active hepatitis B/C infection or heart issues are excluded.Check my eligibility
What is being tested?
The study tests AZD4573 alone or combined with other cancer drugs in patients who have either r/r PTCL or r/r cHL. It aims to confirm the drug's safety profile and how it affects the body while evaluating its effectiveness against these cancers. If successful in early phases (Module 1), a larger Phase II trial may be launched to further assess AZD4573's potential benefits.See study design
What are the potential side effects?
While specific side effects of AZD4573 aren't detailed here, similar cancer treatments often cause fatigue, nausea/vomiting, diarrhea/constipation; blood-related issues like anemia; possible allergic reactions; increased risk of infections due to weakened immune systems; liver function changes; nerve damage that can lead to numbness/pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of lymphoma and can care for myself.
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I have a lymphoma lesion larger than 1.5 cm that shows up on scans.
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My condition worsened or didn't respond after at least one treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 (cycle length is 35 days), day 1 of weeks 1-3 and cycle 2 (cycle length is 21 days), day 1 and day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 (cycle length is 35 days), day 1 of weeks 1-3 and cycle 2 (cycle length is 21 days), day 1 and day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Area under plasma concentration time curve from zero to infinity (AUC0-inf) of AZD4573
Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of AZD4573
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of AZD4573
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZD4573 (Monotherapy)Experimental Treatment1 Intervention
Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD4573
2017
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,605,230 Total Patients Enrolled

Media Library

AZD4573 (Epigenetic Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05140382 — Phase 2
Peripheral T-Cell Lymphoma Research Study Groups: AZD4573 (Monotherapy)
Peripheral T-Cell Lymphoma Clinical Trial 2023: AZD4573 Highlights & Side Effects. Trial Name: NCT05140382 — Phase 2
AZD4573 (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05140382 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to become a participant in this experiment?

"This clinical trial is enrolling 81 adults aged 18-130 with relapsed/refractory classical Hodgkin lymphoma. Other requirements include a Eastern Cooperative Oncology Group performance status of ≤ 2, recurrence or progressive disease after completion of prior line(s) of therapy, uric acid level < ULN at screening (if hyperuricaemia exists SoC must be administered), willingness to participate in all evaluations and procedures including IV drug administration if needed for 24 hours, availability of fresh or archival tumour tissue confirmed at screening, adequate haematologic function at screening, PTCL participants willing to provide mandatory baseline"

Answered by AI

Has AZD4573 been approved by the US Food and Drug Administration?

"After rigorous evaluation, our experts assigned a score of 2 to AZD4573's safety since the current Phase 2 trial has not yet provided evidence for efficacy but there is some data confirming its security."

Answered by AI

Is this trial accessible to elderly individuals?

"The qualifications for this medical study specify that the age range of participants must be between 18 to 130 years old. Simultaneously, there are 305 clinical trials open to people under the age of majority and 1581 studies recruiting patients aged 65 or higher."

Answered by AI

How many patients are currently participating in this trial?

"Affirmative. According to clinicaltrials.gov, the study posted on December 15th 2021 is still recruiting patients. A total of 81 individuals need to be enrolled across 7 different medical sites."

Answered by AI

Is it possible for participants to join this clinical trial at present?

"Affirmative. Records hosted on clinicaltrials.gov validate that this research study, which was initially posted on December 15th 2021, is currently looking for candidates. Approximately 81 individuals must be sought from 7 distinct medical centres."

Answered by AI

Are there multiple facilities initiating this research within the boundaries of our state?

"Presently, 7 trial centres are enrolling patients. These sites span from Duarte to Seattle and Ventura with other in-between locations. To reduce travel strain on participants, it is optimal that you join the closest research site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL
2021. "AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05140382.
~16 spots leftby Apr 2025
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