- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05140382
AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL
A Modular Phase II, Open-label, Multicentre Study to Assess AZD4573 Efficacy and Safety as Monotherapy or in Combination With Anti-cancer Agents in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or Classical Hodgkin Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Clayton, Australia, 3168
- Research Site
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Melbourne, Australia, 3000
- Research Site
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Nedlands, Australia, 6009
- Research Site
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Besançon, France, 25000
- Research Site
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Clermont Ferrand, France, 63003
- Research Site
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Creteil, France, 94010
- Research Site
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Lille Cedex, France, 59037
- Research Site
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MONTPELLIER Cedex 5, France, 34295
- Research Site
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Bologna, Italy, 40138
- Research Site
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Napoli, Italy, 80131
- Research Site
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Seoul, Korea, Republic of, 03722
- Research Site
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Seoul, Korea, Republic of, 05505
- Research Site
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Seoul, Korea, Republic of, 03080
- Research Site
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Seoul, Korea, Republic of, 06351
- Research Site
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Singapore, Singapore, 119074
- Research Site
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Singapore, Singapore, 169608
- Research Site
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Singapore, Singapore, 322605
- Research Site
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Lund, Sweden, 221 85
- Research Site
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Kaohsiung City, Taiwan, 83301
- Research Site
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Taichung, Taiwan, 40447
- Research Site
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Tainan, Taiwan, 70403
- Research Site
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Taipei, Taiwan, 100
- Research Site
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Headington, United Kingdom, 0X3 7LJ
- Research Site
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London, United Kingdom, NW1 2PG
- Research Site
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California
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Duarte, California, United States, 91010
- Research Site
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Research Site
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Research Site
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Texas
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Houston, Texas, United States, 77030
- Research Site
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Utah
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Salt Lake City, Utah, United States, 84112
- Research Site
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Washington
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Seattle, Washington, United States, 98104
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants who are diagnosed with one of the following, as defined by the World Health Organisation:
- Peripheral T-cell Lymphoma
- Classical Hodgkin Lymphoma
- Eastern Cooperative Oncology Group performance status of ≤ 2.
Must have received at least 1 prior line of therapy for the treatment of current disease and have documented relapsed or refractory active disease requiring treatment, defined as:
- Recurrence of disease after response to prior line(s) of therapy, or
- Progressive disease after completion of or on the treatment regimen preceding entry into the study, or
- Disease which did not achieve an objective response (CR or PR).
- Uric acid level < ULN at screening. If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.
- Willing and able to participate in all required evaluations and procedures in this study protocol including receiving IV administration of study drug and being admitted, if required, for at least 24 hours during study drug administration.
- Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.
- Adequate haematologic function at screening.
- PTCL Only: All participants with PTCL must be willing and able to provide baseline bone marrow aspirate and/or biopsy no older than 3 months and agree to undergo post-treatment bone marrow biopsy when required to confirm response.
Additional Module 1 Inclusion Criteria
Prior lines of therapy:
PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.
- Non NK-PTCL (Cohort 1): Prior therapy must have included an alkylating agent and/or anthracycline. In addition, ALCL participants must have received brentuximab vedotin (BV) as part of prior therapy.
- NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase.
- cHL (Cohort 3): Participants must have failed at least 2 prior therapies for the treatment of cHL (including BV and anti-PD1) except where unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease.
- Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm (according to the Lugano (2014) criteria [Cheson et al 2014]).
Exclusion Criteria
Type of Participant and Disease Characteristics:
- PTCL only: Presence of bulky disease (defined as largest lymphoma lesion ≥ 10 cm) or a LDH value > 3 x ULN.
- PTCL only: Diagnosis of any of the following: Lymphoblastic/precursor T-cell lymphoma or leukaemia; T-cell prolymphocytic leukaemia; T-cell large granular lymphocytic leukaemia; Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome).
Medical Conditions:
- With the exception of alopecia and neuropathy, presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
- Presence of, or history of, CNS lymphoma, leptomeningeal disease, or spinal cord compression.
History of prior non-haematological malignancy except for the following:
- Malignancy treated with curative intent and with no evidence of active disease present for more than 1 year prior to screening and felt to be at low risk for recurrence by treating physician.
- Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
- Adequately treated carcinoma in situ without current evidence of disease.
Any evidence of:
- Severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]).
- Current unstable or uncompensated respiratory or cardiac conditions.
- Uncontrolled hypertension.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- IV anti-infective treatment within 1 week before first dose of study drug.
- Known history of infection with HIV.
Serologic status reflecting active hepatitis B or C infection:
- Participants who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative PCR result before enrolment. Those who are hepatitis B surface antigen positive or hepatitis B PCR-positive will be excluded.
- Participants who are hepatitis C antibody positive will need to have a negative PCR result before enrolment. Those who are hepatitis C PCR-positive will be excluded.
Any of the following cardiac criteria:
- Resting QT interval corrected using Fridericia's formula (QTcF) ≥ 470 msec obtained from a single ECG.
- Any clinically important abnormalities in rhythm (except for participants with a pacemaker in place), conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
- Documented confirmation and ongoing treatment of adrenal gland insufficiency or pancreatitis.
Undergone any of the following procedures or experienced any of the following conditions within 6 months prior to first dose:
- Coronary artery bypass graft
- Angioplasty
- Vascular stent
- Myocardial infarction
- Angina pectoris
- CHF (New York Heart Association Class ≥ 2)
- Ventricular arrhythmias requiring continuous therapy
- Atrial fibrillation, which is judged as uncontrolled by the treating physician
- Haemorrhagic or thrombotic stroke, including transient ischemic attacks or any other CNS bleeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AZD4573 (Monotherapy)
Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy.
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AZD4573 will be given intravenously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Objective Response Rate (ORR)
Time Frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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The efficacy of AZD4573 will be assessed by evaluation of ORR.
Proportion of participants who have a overall response of complete response [CR] or partial response [PR] according to the Lugano (2014) response criteria for malignant lymphoma.
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From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-free survival (PFS)
Time Frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Efficacy of AZD4573 will be assessed by evaluation of tumour response.
The time from first dose date to documented disease progression, or death from any cause, whichever occurs first.
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From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Overall survival (OS)
Time Frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Efficacy of AZD4573 will be assessed by evaluation of overall survival.
The time from first dose date to death from any cause.
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From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Frequency of Adverse events (AE) and Serious AEs (SAE)
Time Frame: From Cycle 1 (this cycle is 35 days in length) until Safety follow-up (30 days after the last dose of all study drug) and long term follow-up (upto 2 years)
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The safety and tolerability of AZD4573 will be assessed
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From Cycle 1 (this cycle is 35 days in length) until Safety follow-up (30 days after the last dose of all study drug) and long term follow-up (upto 2 years)
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Maximum observed plasma (peak) drug concentration (Cmax) of AZD4573
Time Frame: 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
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The plasma PK of AZD4573 will be assessed.
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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
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Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of AZD4573
Time Frame: 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
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The plasma PK of AZD4573 will be assessed.
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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
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Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of AZD4573
Time Frame: 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
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The plasma PK of AZD4573 will be assessed.
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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
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Area under plasma concentration time curve from zero to infinity (AUC0-inf) of AZD4573
Time Frame: 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
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The plasma PK of AZD4573 will be assessed.
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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
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Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD4573
Time Frame: 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
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The plasma PK of AZD4573 will be assessed.
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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
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Half-life (t1/2) of AZD4573
Time Frame: 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
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The plasma PK of AZD4573 will be assessed.
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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
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Complete response (CR) rate
Time Frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Efficacy of AZD4573 will be assessed by evaluation of tumour response.
Proportion of participants who have a complete response according to the Lugano (2014) response criteria.
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From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Duration of response (DoR)
Time Frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Efficacy of AZD4573 will be assessed by evaluation of tumour response.
The time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurs first.
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From Screening (Day -30 to Day-1) until disease progression or survival until death (approximately 6 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8231C00001
- 2021-002570-54 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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