Relapsed/Refractory Peripheral T-cell LymphomaPhase 2NCT05140382
AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL
A Phase 2 study testing AZD4573 in people with Relapsed/Refractory Peripheral T-cell Lymphoma and Relapsed/Refractory Classical Hodgkins Lymphoma, run by AstraZeneca at 27 sites in 8 countries.
Trial summary
This is a modular dose confirmation and expansion study. The core study design is to assess the efficacy of AZD4573, administered as monotherapy or combination therapy, to participants with either r/r PTCL or r/r cHL and to confirm the safety profiles and PK in these populations. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Relapsed/Refractory Peripheral T-cell Lymphoma, Relapsed/Refractory Classical Hodgkins Lymphoma
- What is being tested?
- AZD4573
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 27 sitesin 8 countries
- Study dates
- 15 Dec 2021to 16 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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]).
Who cannot join
- 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.
Show all 35Show fewer
- 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
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
United States6 sites
Research Site
Boston, Massachusetts, 02215
Research Site
Duarte, California, 91010
Research Site
Hackensack, New Jersey, 07601
Research Site
Houston, Texas, 77030
Research Site
Salt Lake City, Utah, 84112
Research Site
Seattle, Washington, 98104
France5 sites
Research Site
Besançon, 25000
Research Site
Clermont-Ferrand, 63003
Research Site
Créteil, 94010
Research Site
Lille, 59037
Research Site
Montpellier, 34295
South Korea4 sites
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Taiwan4 sites
Research Site
Kaohsiung City, 83301
Research Site
Taichung, 40447
Research Site
Tainan, 70403
Research Site
Taipei, 100
Australia3 sites
Research Site
Clayton, 3168
Research Site
Melbourne, 3000
Research Site
Nedlands, 6009
United Kingdom2 sites
Research Site
Headington, 0X3 7LJ
Research Site
London, NW1 2PG
About this study
Official title: 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
This is a modular dose confirmation and expansion study. The core study design is to assess the efficacy of AZD4573, administered as monotherapy or combination therapy, to participants with either r/r PTCL or r/r cHL and to confirm the safety profiles and PK in these populations. Module 1 of this study will evaluate the efficacy, safety, and tolerability of AZD4573 monotherapy in participants with r/r PTCL or r/r cHL. If AZD4573 monotherapy is found to have promising anti-tumour efficacy in Module 1, an AZD4573 monotherapy Phase II expansion may be added via a substantial protocol amendment.
Read the detailed description
Module 1 will consist of two r/r PTCL cohorts and one cHL cohort; and each cohort includes 21 participants. A comprehensive initial review of all safety and PK/PD data will be conducted in approximately the first 6 participants of each cohort (safety run-in), with separate Safety Review Committees (SRCs) for each cohort executed independently. The safety assessment will be undertaken by the SRC. Each cohort will have a separate dose confirmation, assessed independently by the SRC, to assess safety and PK/PD data compared to the known profiles in the first time in human study (Study D8230C00001) lymphoma population. These SRC reviews will confirm whether the recommended phase II dose for lymphoma (IV infusion 12 mg once weekly, including intra-participant ramp-up) is safe and tolerable or if additional dose optimisation is indicated at a revised dose and/or schedule. All cohorts can be opened and delivered independently of each other.
- Conditions
- Relapsed/Refractory Peripheral T-cell Lymphoma, Relapsed/Refractory Classical Hodgkins Lymphoma
- Being tested
- AZD4573
- Keywords
- AZD4573, Modular study, Dose confirmation, Dose expansion
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4573Drug
AZD4573 will be given intravenously
| Study group | Role | What they receive |
|---|---|---|
| AZD4573 (Monotherapy) | Experimental | Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy. Receives: Drug: AZD4573 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who have a tumour response of complete response [CR] or partial response [PR] according to the Lugano (2014) response criteria for malignant lymphoma.
Measured: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)
Secondary outcomes (13)
Complete Response (CR) Rate
Complete response rate is defined as proportion of participants who have a complete response according to the Lugano (2014) response criteria.
Measured: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Duration of Response (DoR)
Duration of response is defined as the time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurs first.
Measured: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Progression-free Survival (PFS)
Progression-free survival is defined as the time from the date of first dose to documented disease progression, or death from any cause, whichever occurs first.
Measured: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Overall Survival (OS)
Overall survival is defined as the time from the date of first dose to death from any cause.
Measured: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
The safety and tolerability of AZD4573 was assessed.
Measured: From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-inf) of AZD4573
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Time to Reach Peak Observed Concentration Following Drug Administration (Tmax)
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Half-life (t1/2) of AZD4573
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Systematic Clearance (CL)
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Volume of Distribution at Terminal Phase (Vz)
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Volume of Distribution at Steady State (Vss)
The plasma PK of AZD4573 when administered in participants was assessed.
Measured: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Dec 2021
- Primary completion25 Aug 2023
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed/Refractory Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140382
- Sponsor's protocol ID
- D8231C00001
- Other IDs
- 2021-002570-54
- Status last verified
- Jul 2024
- First submitted
- 17 Nov 2021
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05140382
- Acronym / sponsor ID
- D8231C00001
- Conditions
- Relapsed/Refractory Peripheral T-cell Lymphoma, Relapsed/Refractory Classical Hodgkins Lymphoma
- Keywords
- AZD4573, Modular study, Dose confirmation, Dose expansion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a modular dose confirmation and expansion study. The core study design is to assess the efficacy of AZD4573, administered as monotherapy or combination therapy, to participants with either r/r PTCL or r/r cHL and to confirm the safety profiles and PK in these populations. Module 1 of this study will evaluate the efficacy, safety, and tolerability of AZD4573 monotherapy in participants with r/r PTCL or r/r cHL. If AZD4573 monotherapy is found to have promising anti-tumour efficacy in Module 1, an AZD4573 monotherapy Phase II expansion may be added via a substantial protocol amendment.
Detailed description
Module 1 will consist of two r/r PTCL cohorts and one cHL cohort; and each cohort includes 21 participants. A comprehensive initial review of all safety and PK/PD data will be conducted in approximately the first 6 participants of each cohort (safety run-in), with separate Safety Review Committees (SRCs) for each cohort executed independently. The safety assessment will be undertaken by the SRC. Each cohort will have a separate dose confirmation, assessed independently by the SRC, to assess safety and PK/PD data compared to the known profiles in the first time in human study (Study D8230C00001) lymphoma population. These SRC reviews will confirm whether the recommended phase II dose for lymphoma (IV infusion 12 mg once weekly, including intra-participant ramp-up) is safe and tolerable or if additional dose optimisation is indicated at a revised dose and/or schedule. All cohorts can be opened and delivered independently of each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD4573 (Monotherapy) | Experimental | Drug: AZD4573Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participants who are diagnosed with one of the following, as defined by the World Health Organisation:
- 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:
- 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.
Key exclusion criteria (35 listed)
- 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).
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4573AZD4573 will be given intravenously | Drug | AZD4573 (Monotherapy) |
Primary outcome
Objective Response Rate (ORR)
Time frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)
Objective response rate is defined as the proportion of participants who have a tumour response of complete response [CR] or partial response [PR] according to the Lugano (2014) response criteria for malignant lymphoma.
13 secondary outcomes
Complete Response (CR) Rate
Time frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Duration of Response (DoR)
Time frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Progression-free Survival (PFS)
Time frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Overall Survival (OS)
Time frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Time frame: From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
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.
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
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.
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.
Time to Reach Peak Observed Concentration Following Drug Administration (Tmax)
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.
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.
Systematic Clearance (CL)
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.
Volume of Distribution at Terminal Phase (Vz)
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.
Volume of Distribution at Steady State (Vss)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSP redactedLink provided by the sponsor.
- SAP redactedLink provided by the sponsor.
- CSR Synopsis redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD4573 in people with Relapsed/Refractory Peripheral T-cell Lymphoma and Relapsed/Refractory Classical Hodgkins Lymphoma, run by AstraZeneca at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, France, South Korea, Taiwan, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.