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New pill shows promise for Tough-to-Treat lymphoma

NCT ID NCT06511895

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested an oral drug called AZD4205 in 57 adults with relapsed or refractory peripheral T-cell lymphoma, a rare blood cancer. The study aimed to see if the drug can shrink tumors and how safe it is. Participants took a capsule once daily in 28-day cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD4205 (an oral drug taken as a capsule once daily)
What this could lead to
If successful, this could provide a new treatment option for people with peripheral T-cell lymphoma that has not responded to prior therapy.
What could go wrong
This is a small, early-phase trial (57 participants) with no comparison group. The drug may not work for many patients, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

57 people

The number who actually took part.

Started

May 2022

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. ≥ 18 years old (for Korean ≥ 19 years old) 2. ECOG performance status 0-2 with no deterioration over the previous 2 weeks 3. Predicted life expectancy ≥ 12 weeks. 4. Histologically confirmed PTCL by local pathology review according to the 2016 revision of the WHO classification of lymphoid neoplasms. Eligible histological subtypes are restricted to the following: * PTCL-NOS * AITL * ALCL ALK+ * ALCL ALK- * EATL * MEITL * NKTCL * HSTCL * SPTCL 5. Have measurable disease according to the 2014 Lugano classification 6. Must have progressed on or are refractory to standard systemic therapy, or patients were intolerant to standard systemic therapy. Participants should be transplant-ineligible upon their entries to this study. 7. Adequate bone marrow reserve and organ system functions 8. LVEF ≥ 55% assessed by ECHO or MUGA. 9. Male participant with female partners of child-bearing potential should be willing to use barrier contraceptives (i.e., by use of condoms), during his participation in this study and for 6 months following the last dose of the study drug. Male participant must refrain from donating sperm during their participation in the study and at least for 6 months after the last treatment. 10. Female participant should be using adequate contraceptive measures while on study drug and for 3 months following the last dose of study drug. Exclusion criteria: 1. Intervention with any of the following: * Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment. * Any cytotoxic chemotherapy from a previous treatment regimen within 21 days of the first dose of study treatment. * Prior HDAC inhibitors (including romidepsin, belinostat and chidamide) or pralatrexate therapy within one week of the start of the study treatment. * Corticosteroids at dosages equivalent to prednisone \> 15 mg/day within 7 days of the start of the study treatment. * Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study. * Prior therapeutic anticancer antibodies (including brentuximab vedotin) within 4 weeks, other radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks. * Has undergone an allogeneic stem cell transplant. Participant had autologous stem cell transplant within 6 months. * Prior treatment with a JAK or STAT3 inhibitor. * Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of AZD4205. * Live vaccines within 28 days prior to first dose. * Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) vitamin K antagonists, anti-platelet agents or anticoagulated agents. * Currently receiving (or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP or P-gp with narrow therapeutic index. 2. Any unresolved toxicities from prior therapy, greater than CTCAE v 5.0 Grade 1 at the time of starting study treatment with the exception of alopecia. 3. Central nervous system or leptomeningeal lymphoma. 4. With severely decreased lung function (i.e. any parameter of FEV1, and DLCO \< 60% of predicted value). Past medical history of pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. 5. With disease condition which requires the treatment of immunosuppressants, biologics, or NSAIDs (non-steroid anti-inflammatory drugs). 6. Active infections including: * History of known latent or active tuberculosis (TB). * Known infection with HIV, or serologic status reflecting active hepatitis B or hepatitis C infection. * Active viral infections (i.e. zoster) other than hepatitis B or C. * Infections requiring oral or intravenous antimicrobial therapy or interferon. * Bacterial infections including pneumonia within 30 days. 7. Any of the following cardiac criteria: * Congestive heart failure (CHF) per NYHA classification \> Class II. * Clinically significant valvular diseases, hypertrophic or constrictive cardiomyopathy. * Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \> 250 msec. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. * AMI within 6 months prior to starting treatment, unstable angina or new-onset angina. * With heart transplant. * Mean resting corrected QTcF interval (QTC) \> 450 ms on ECG. * With factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalaemia, congenital long QT syndrome, any concomitant medication known to prolong the QT interval) or family history of long QT interval syndrome or unexplained sudden death under 40 years of age in first degree relatives. * With previous/current thrombotic diseases such as pulmonary embolism, and deep venous thrombosis. 8. Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Hefei, Anhui, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, China

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Hainan General Hospital

    Haikou, Hainan, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, China

  • Ruijing Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Shandong Cancer Hospital & Insititution

    Jinan, Shandong, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, China

  • The Second Hospital of Anhui Meidcine University

    Hefei, Anhui, China

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, China

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

    Wuhan, Hubei, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

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