What side effects are associated with this type of intervention?

Common treatments for Peripheral T-Cell Lymphoma (PTCL) include chemotherapeutic agents and targeted therapies. Chemotherapy regimens like CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) can cause myelosuppression, nausea, vomiting, alopecia, and peripheral neuropathy. Targeted therapies, such as brentuximab vedotin, often result in peripheral neuropathy, neutropenia, and fatigue. The side effects of AZD4573, being studied as a monotherapy for PTCL, would likely be similar to those of other targeted therapies or chemotherapeutic agents.

What prior FDA approvals exist?

FDA-approved treatments for Peripheral T-Cell Lymphoma (PTCL) include histone deacetylase (HDAC) inhibitors like romidepsin and belinostat, which work by altering gene expression to induce cancer cell death. Pralatrexate, an antifolate chemotherapy agent, disrupts DNA synthesis in cancer cells. Additionally, brentuximab vedotin, a monoclonal antibody targeting CD30, is approved for certain PTCL subtypes. These treatments offer various mechanisms to target and manage PTCL.

What other types of research exist?

Promising novel alternatives to AZD4573 for PTCL patients include pembrolizumab, TTI-621, BNZ-1, and MRG-106. These treatments are still in trials and have shown potential in related lymphomas, though further combinatorial studies are needed to establish long-term efficacy.

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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

Must not have

Presence of bulky disease (defined as largest lymphoma lesion ≥ 10 cm) or a LDH value > 3 x ULN

Known history of infection with HIV

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.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AZD4573 on patients with difficult-to-treat lymphomas. The drug is given through an IV and aims to kill cancer cells. The study will check if the drug is safe and effective.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My largest lymphoma is 10 cm or larger, or my LDH levels are more than three times the upper limit.

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I have been diagnosed with HIV.

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I have no major side effects from previous treatments.

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I have cancer affecting my brain, spinal cord, or its coverings.

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I am currently being treated for adrenal gland insufficiency or pancreatitis.

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I have been diagnosed with a specific type of T-cell cancer.

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I do not have severe illnesses or uncontrolled conditions like heart disease, high blood pressure, or infections.

Timeline

Screening ~ 3 weeks3 visits

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.

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.

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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-inf) of AZD4573

Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)

Complete Response (CR) Rate

+10 more

Side effects data

From 2024 Phase 2 trial • 52 Patients • NCT05140382

77%

Neutropenia

68%

Aspartate aminotransferase increased

61%

Alanine aminotransferase increased

45%

Blood bilirubin increased

42%

Thrombocytopenia

39%

Diarrhoea

35%

Hypokalaemia

35%

Anaemia

32%

Gamma-glutamyltransferase increased

32%

Nausea

26%

Hypocalcaemia

26%

Vomiting

19%

Constipation

19%

White blood cell count decreased

16%

Pyrexia

16%

Hyperphosphataemia

13%

Hypomagnesaemia

13%

Pneumonia

13%

Hypophosphataemia

13%

Blood phosphorus increased

13%

Escherichia sepsis

13%

Muscle spasms

13%

Febrile neutropenia

10%

Abdominal pain

10%

Catheter site thrombosis

10%

Blood phosphorus decreased

10%

Rash

10%

Amylase increased

10%

Blood alkaline phosphatase increased

10%

Leukopenia

10%

Back pain

10%

Oedema peripheral

10%

Blood potassium increased

Liver function test increased

Hyponatraemia

Abdominal pain upper

Bilirubin conjugated increased

Blood triglycerides increased

Lipase increased

Headache

Lymphocyte count decreased

Blood potassium decreased

Cough

Alopecia

Non-cardiac chest pain

Prothrombin time prolonged

Pain in extremity

Hyperglycaemia

Urinary tract infection

Troponin increased

Hyperkalaemia

Tumour lysis syndrome

Hypotension

Staphylococcal bacteraemia

Blood creatinine increased

Rash maculo-papular

Pain

Blood lactate dehydrogenase increased

COVID-19

Arthralgia

International normalised ratio increased

Decreased appetite

Liver injury

Blood cholesterol increased

Vascular device infection

Chills

Fanconi syndrome acquired

Fall

Activated partial thromboplastin time prolonged

Fibrin D dimer increased

Vision blurred

Acute kidney injury

Herpes zoster

Infection

Blood fibrinogen increased

Dizziness

Pruritus

Stomatitis

Pneumonia viral

Anxiety

Upper respiratory tract infection

Blood calcium decreased

Staphylococcal sepsis

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 Non-NK PTCL

Cohort 3 cHL

Cohort 2 NK PTCL

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral T-Cell Lymphoma (PTCL) is commonly treated with chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as histone deacetylase inhibitors and monoclonal antibodies, specifically target cancer cell pathways and surface proteins, minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. Understanding these mechanisms is crucial for PTCL patients as it helps in selecting the most effective treatment with manageable side effects, and it provides insight into how new treatments like AZD4573 might offer improved outcomes by potentially targeting specific pathways involved in PTCL.