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Peripheral T-cell LymphomaPhase 2NCT06511869

AZD4205 in Peripheral T Cell Lymphoma Following First-Line Therapy (JACKPOT26)

A Phase 2 study testing AZD4205 in people with Peripheral T-cell Lymphoma, run by Dizal Pharmaceuticals at 23 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is intended to assess the safety and anti-tumor activity of AZD4205 at 150 mg once daily in participants with PTCL who have achieved tumor response after first-line systemic therapy (with or without combination radiotherapy) and are ineligible for HSCT assessed by the investigator as ineligible for HSCT or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
AZD4205
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
23 sitesChina
Study dates
17 Mar 2022to 31 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years old.
  • ECOG status score ranging from 0 to 1, without any deterioration in the past two weeks.
  • Life expectancy ≥ 3 months.
  • Have histopathologically confirmed PTCL that meets the pathological subtypes (except for ALCL-ALK+) as specified in the latest WHO classification of lymphoid neoplasms in 2016.
  • Must be assessed to achieve complete or partial response according to Lugano's criteria after first-line systemic standard of therapy:
  • The participants should be assessed as ineligible for HSCT
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  • For participants with CR, the end of initial treatment should be ≤ 3 months from the planned first dose in this study.
  • Adequate bone marrow hematopoietic function and organ function reserve.
  • LVEF ≥ 50% by ECHO.
  • Should be able to follow the relevant requirements of this study for medication and follow-up.
  • If there is a potential for conception for the female spouses (partners) of male participants, the spouses (partners) should take physical contraceptive measures (such as condoms) during the participant participating in the trial and within 6 months after the end of treatment.
  • Male participants should also avoid sperm donation during the trial and within 6 months after the end of treatment.
  • Female participants should take adequate contraceptive measures and vasoligation of the partner during the trial and within 3 months after the end of the trial. All hormonal contraceptive methods (except abstinence) should be used in conjunction with the use of a condom by the male partner. Breastfeeding is prohibited for female participants. Female participants of conception potential should have a negative pregnancy test prior to initiation of treatment.

Who cannot join

  • With any of the following treatment history:
  • The use of the investigational product or investigational product in another project within 30 days prior to the start of dosing in this study.
  • The cytotoxic chemotherapeutic agents are not discontinued within 21 days prior to the start of dosing in this study.
  • Prior use of histone deacetylase (HDAC) inhibitors (e.g., romidepsin, chidamide, belinostat) or pralatrexate within 1 week prior to the start of dosing in this study.
  • Prior use of corticosteroid therapy at equivalent prednisone dose > 15 mg/day within 1 week prior to the start of dosing in this study.
  • Undergoing major surgery (excluding vascular access surgery) or serious trauma within 4 weeks prior to the start of dosing in this study; or anticipated to undergo potential surgery after the start of dosing in this study.
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  • Prior use of anti-tumor macromolecular antibody agents (including brentuximab vedotin) within 4 weeks; radiation therapy within 3 weeks; and other toxin/isotope-immune antibody couplers within 10 weeks prior to the start of dosing in this study.
  • With prior use of JAK or STAT3 inhibitors.
  • Prior use of anti-tumor immunotherapy (e.g., immune checkpoint inhibitors, including PD-1, PD-L1, and CTLA-4) within 28 days prior to the start of dosing in this study. For participants treated with other types of novel therapy, whether they can be included may be jointly decided by the investigator and the sponsor's study physician.
  • Vaccination with attenuated vaccines or viral vector vaccines within 28 days prior to the start of dosing in this study.
  • Currently on treatment with vitamin K antagonists, antiplatelets, and anticoagulants (or these drugs cannot be discontinued within 1 week prior to the start of dosing in this study).
  • Currently on treatment with (or unable to discontinue the use within 1 week prior to the start of dosing in this study) certain known drugs, herbs, or supplements that may significantly induce or inhibit CYP3A or can serve as sensitive substrates of BCRP/P-gp, with low therapeutic indexes.
  • With unresolved > CTCAE Grade 1 adverse drug reactions (except alopecia) prior to the start of dosing in this study.
  • Central nervous system or meninges involvement by the lymphoma.
  • With significant lung function impairment (i.e., pulmonary function tests show FEV1 and DLCO < 60% of predicted values). Participants with prior history of non-infectious pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or evidence showing clinically active interstitial lung disease.
  • With diseases or conditions requiring treatment with immunosuppressive agents, similar biological agents, or non-steroidal analgesic-antipyretic drugs.
  • Active infection, including:
  • Known active/latent tuberculosis (screening should be performed according to the routine procedures of local clinical sites, such as PPD test, T-SPOT, and X-ray/CT).
  • With positive HIV test or serological hepatitis markers.
  • Active viral infections (e.g., herpes zoster) other than hepatitis B or hepatitis C.
  • Infections requiring oral or intravenous antimicrobial therapy.
  • Bacterial infection within 30 days, including pneumonia.
  • Any of the following cardiac abnormalities:
  • With congestive heart failure (CHF) > NYHA Class II.
  • With significant clinical manifestations of valvular disease and hypertrophic/constrictive cardiomyopathy.
  • With serious cardiac rhythm, conduction, morphological abnormalities on any resting ECG, such as complete left bundle branch block, 2/3-degree atrioventricular block, and PR interval > 250 ms.
  • Ventricular arrhythmia requiring treatment.
  • Acute myocardial infarction (AMI) within 6 months prior to the start of treatment in the trial; unstable angina pectoris or new angina pectoris.
  • Who have undergone heart transplantation.
  • Corrected QTcF interval (QTc) > 450 ms on resting ECG at screening.
  • With increased risks of QT prolongation or arrhythmia (e.g., heart failure, hypokalemia, congenital long QT syndrome, or taking other drugs causing QT prolongation; or with a family history of long QT syndrome; or those with first-degree relatives showing unexpected sudden death under 40 years of age.
  • Prior or current history of thrombotic diseases such as pulmonary embolism and deep vein thrombosis.
  • Prior history of malignancies (except completely eradicated cervical, uterine, basal cell, or squamous cell carcinoma in situ, or non-melanoma skin carcinoma in situ) within 5 years prior to enrollment.
  • With symptoms of intractable nausea or vomiting that cannot be well controlled with supportive treatment, chronic gastrointestinal disease, capsule dysphagia, or prior surgical removal of bowel segments that may compromise adequate absorption of the drug.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Peking university Third Hospital

    Beijing, Beijing Municipality

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Research Center of Clinical Trials, The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Hainan General Hospital

    Haikou, Hainan

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • Anhui Provincial Hospital (The First Affiliated Hospital of USTC)

    Hefei, Anhui

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Shandong Cancer Hospital & Institution

    Jinan, Shandong

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • Linyi Cancer Hospital

    Linyi, Shandong

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: A Phase II, Open-Label, Multicenter Study to Assess the Safety and Anti-Tumor Efficacy of AZD4205 in Participants With Peripheral T Cell Lymphoma Who Have Responded After First-Line Standard Therapy

This study is intended to assess the safety and anti-tumor activity of AZD4205 at 150 mg once daily in participants with PTCL who have achieved tumor response after first-line systemic therapy (with or without combination radiotherapy) and are ineligible for HSCT assessed by the investigator as ineligible for HSCT or have no plan for HSCT.

Being tested
AZD4205
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD4205Drug

    AZD4205 capsules administered at 150 mg orally, once daily, in 28-day cycle.

Study groups in NCT06511869
Study groupRoleWhat they receive
AZD4205 treatmentExperimentalCohort 1: Participants achieving a CR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy. Cohort 2: Participants achieving a PR as assessed by the investigator according to Lugano criteria following the first-line systemic therapy.
Receives: Drug: AZD4205

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events and serious adverse events (graded by CTCAE version 5.0)

    To assess the safety and tolerability of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

    Measured: up to 2 years

Secondary outcomes (6)

  1. Cohort 1: Disease Free Survival (DFS)

    To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

    Measured: up to 2 years

  2. Cohort 1: Disease Free Survival (DFS) rate at 1 year from the first dose of investigational product

    To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

    Measured: 1 year

  3. Cohort 2: Objective Response Rate (ORR)

    To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

    Measured: up to 2 years

  4. Cohort 2: Duration of Response (DoR)

    To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

    Measured: up to 2 years

  5. Cohort 2: Progression-free Survival (PFS)

    To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

    Measured: up to 2 years

  6. Cohort 2: Progression-free Survival (PFS) rate at 1 year from the first dose of investigational product

    To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2024
  2. Study start17 Mar 2022
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06511869
Sponsor's protocol ID
DZ2021J0005
Status last verified
Jul 2025
First submitted
15 Jul 2024
Last updated
4 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD4205 in people with Peripheral T-cell Lymphoma, run by Dizal Pharmaceuticals at 23 sites in China.

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 13 inclusion and 34 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse events and serious adverse events (graded by CTCAE version 5.0) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06511869.

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 4 Jul 2025.

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