Promising combo tackles rare blood cancer in chinese patients
NCT ID NCT05673785
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of brentuximab vedotin plus standard chemotherapy (CHP) in 52 Chinese adults with a rare type of lymphoma called CD30+ peripheral T-cell lymphoma. The goal is to see how well the treatment shrinks tumors and to monitor side effects. Participants receive the drugs through an IV and oral pills over 21-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
- brentuximab vedotin combined with cyclophosphamide, doxorubicin, and prednisone
- What this could lead to
- If successful, this could provide a new first-line treatment option for Chinese patients with CD30+ peripheral T-cell lymphoma, potentially improving response rates.
- What could go wrong
- This is a small, single-arm phase 2 trial with no placebo group, so results may not be definitive. Side effects from the chemotherapy combination could be significant.
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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52 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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. Participants must have newly diagnosed CD30+ PTCL, per the Revised European American Lymphoma 2016 World Health Organization (WHO) classification, by local assessment. Tumor specimen must be submitted before enrollment for subsequent central pathology review to confirm histology (and anaplastic lymphoma kinase (ALK) status, if applicable), and CD30 expression. Eligible histologies include: 1. ALK-positive systemic anaplastic large cell lymphoma (sALCL) with an International Prognostic Index (IPI) score of ≥2. 2. ALK-negative sALCL. 3. PTCL- not otherwise specified (NOS). 4. Angioimmunoblastic T-cell lymphoma (AITL). 5. Enteropathy associated T-cell lymphoma (EATL). 6. Hepatosplenic T-cell lymphoma (HSTCL). 2. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2. 3. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) imaging and measurable disease with at least 1 bidimensionally measurable lesion (\>1.5 cm in its largest dimension) by computed tomography (CT). 4. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and immunogenicity sampling. 5. Clinical laboratory values as specified below at screening/baseline within 7 days before the first dose of study drug: 1. Total bilirubin must be ≤1.5 times the upper limit of normal (ULN) or ≤3 times the ULN for participants with Gilbert's disease or documented hepatic involvement with lymphoma. 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤3 times the ULN or ≤5 times the ULN for participants with an elevation that can be reasonably ascribed to the presence of metastatic disease in liver. 3. Serum creatinine must be \<2.0 milligram per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance \>40 milliliter (mL)/minute. 4. Hemoglobin must be ≥8 grams per deciliter (g/dL). (Red blood cell transfusion is allowed ≥14 days before assessment.) 5. Absolute neutrophil count \>1.5×10\^9/liter (L). 6. Platelet count ≥75×10\^9/L (unless documented bone marrow involvement with lymphoma). Exclusion Criteria: 1. Systemic anticancer therapy, including traditional Chinese medicine with antitumor indication for disease under study before the first dose of study drugs. 2. Major surgery within 28 days before the first dose of study drug. 3. Known human immunodeficiency virus (HIV)-positive status. 4. Known hepatitis B virus (HBV) surface antigen (HBsAg) seropositivity or active hepatitis C virus infection. Note: Participants who have positive HBV core antibody and are HBsAg negative can be enrolled, but must have an undetectable HBV viral load. 5. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 6. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: 1. Left-ventricular ejection fraction \<45%. 2. Myocardial infarction within 6 months of enrollment. 3. New York Heart Association Class III or IV heart failure. 7. Participants with current diagnosis of primary cutaneous CD30+ T-cell lymphoproliferative disorders and lymphomas. Participants with cutaneous anaplastic large cell lymphoma (ALCL) with extracutaneous tumor spread beyond locoregional lymph nodes are eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible). 8. Participants with mycosis fungoides (MF) \[including transformed MF\]. 9. Uncontrolled diabetes mellitus. 10. Baseline peripheral neuropathy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\], version 5.0). 11. History of progressive multifocal leukoencephalopathy (PML). 12. Previous treatment with brentuximab vedotin or CD30 monoclonal antibody.
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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 Cancer Hospital
Hefei, 230088, China
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Beijing Cancer Hospital
Beijing, 100142, China
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Chongqing University Cancer Hospital
Chongqing, 400030, China
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Fudan University Shanghai Cancer Center
Shanghai, 200032, China
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Fujian Medical University Union Hospital
Fuzhou, 350001, China
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Guangdong Provincial Peoples Hospital
Guangzhou, 510080, China
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Henan Cancer Hospital
Zhengzhou, 450003, China
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Peking University Third Hospital
Beijing, 100191, China
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Shandong Cancer Hospital
Jinan, 250117, China
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Shengjing Hospital of China Medical University
Shenyang, 110022, China
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The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
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The First Affiliated Hospital of Soochow University
Suzhou, 215004, China
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The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, 310003, China
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The First Hospital of Jilin University
Changchun, 130021, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
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West China Hospital, Sichuan University
Chengdu, 610041, China
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