Relaps/Refrakter DLBCL'de HMPL-760 Artı R-GemOx ile Plasebo Artı R-GemOx'un Karşılaştırıldığı Faz III Çalışması

Sade dilde özet

Bu çalışma, tekrarlayan veya tedaviye dirençli (relaps/refrakter) diffüz büyük B hücreli lenfomada (diffuse large B-cell lymphoma, DLBCL) HMPL-760 ilacının R-GemOx kemoterapisiyle birlikte kullanımını, plasebo artı R-GemOx ile karşılaştırarak incelemektedir. Çalışmaya, histopatolojik olarak DLBCL tanısı doğrulanmış, 18 yaş ve üzeri hastalar katılabilmektedir. Çalışma Faz 3 aşamasında yürütülmektedir ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Katılımcı alıyor

Sponsor

Hutchmed

Müdahale

HMPL-760, HMPL-760 Placebo, R-GemOx

Başlangıç

20.03.2026

Tahmini bitiş

30.12.2028

Ülkeler

China

İlgili genler

Merkezler

• Shanghai, China
• Baoding, China
• Beijing, China
• Beijing, China
• Bengbu, China
• Changchun, China
• Changsha, China
• Changsha, China
• Changsha, China
• Chengdu, China
• Chengdu, China
• Chongqing, China
• Chongqing, China
• Fujian, China
• Fuzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guiyang, China
• Hangzhou, China
• Hangzhou, China
• Harbin, China
• Hefei, China
• Jinan, China
• Jinan, China
• Kunming, China
• Nanchang, China
• Nanjing, China
• Nanjing, China
• Nanning, China
• Qingdao, China
• Shanghai, China
• Shanghai, China
• Shenyang, China
• Shenzhen, China
• Taiyuan, China
• Tangshan, China
• Tianjin, China
• Tianjin, China
• Tianjin, China

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

1. Sign the ICF and be able to follow the requirements of study protocol;
2. Age ≥18 years;
3. ECOG performance status score between 0 and 2;
4. Histopathologically confirmed diagnosis of DLBCL;
5. The investigator judges that the patient's current condition requires further treatment;
6. Patients should have at least one bi-dimensionally measurable lesion;
7. Expected survival is more than 12 weeks;

Exclusion Criteria:

1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
3. Organ insufficiency;
4. Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);
5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
7. The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);
8. Clinically significant active infection;