New pill shows promise for Tough-to-Treat lymphoma
NCT ID NCT06511895
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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57 people
The number who actually took part.
- Started
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May 2022
- Finished
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Oct 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Hefei, Anhui, China
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
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Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
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Hainan General Hospital
Haikou, Hainan, China
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Henan Cancer Hospital
Zhengzhou, Henan, China
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Hunan Cancer Hospital
Changsha, Hunan, China
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Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
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Peking University Third Hospital
Beijing, Beijing Municipality, China
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Ruijing Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
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Shandong Cancer Hospital & Insititution
Jinan, Shandong, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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The First Bethune Hospital of Jilin University
Changchun, Jilin, China
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The Second Hospital of Anhui Meidcine University
Hefei, Anhui, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
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West China Hospital of Sichuan University
Chengdu, Sichuan, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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- A microchip implanted in tumors could reveal which drugs work best