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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4205 treatment | Experimental | Cohort 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4205 | Drug | AZD4205 capsules administered at 150 mg orally, once daily, in 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 2 years |
| Cohort 1: Disease Free Survival (DFS) rate at 1 year from the first dose of investigational product |
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Inclusion criteria
≥ 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:
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.
Exclusion criteria
With any of the following treatment history:
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:
Any of the following cardiac abnormalities:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jie Jin | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital (The First Affiliated Hospital of USTC) | Hefei | Anhui | China | |||
| Peking university Third Hospital |
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To assess the anti-tumor activity of AZD4205 as maintenance/consolidation therapy in PTCL participants achieving tumor response after first-line systemic therapy |
| 1 year |
| 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 | up to 2 years |
| 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 | up to 2 years |
| 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 | up to 2 years |
| 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 | 1 year |
| Beijing |
| Beijing Municipality |
| China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
| The Fifth Affiliated Hospital of Sun Yat-sen University | Zhuhai | Guangdong | China |
| Hainan General Hospital | Haikou | Hainan | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Hubei Cancer Hospital | Wuhan | Hubei | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| Research Center of Clinical Trials, The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| Shandong Cancer Hospital & Institution | Jinan | Shandong | China |
| Linyi Cancer Hospital | Linyi | Shandong | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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