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This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Glofitamab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glofitamab | Drug | Glofitamab given in standard dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | 2 year |
| CR rate | complete response | 6 weeks, 18 weeks, 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Relapsed/Refractory Diffuse Large B-Cell Lymphoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Ruan | Contact | +8615201435860 | 15201435860@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36507690 | Background | Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, Khan C, Wrobel T, Offner F, Trneny M, Wu SJ, Cartron G, Hertzberg M, Sureda A, Perez-Callejo D, Lundberg L, Relf J, Dixon M, Clark E, Humphrey K, Hutchings M. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231. doi: 10.1056/NEJMoa2206913. Epub 2022 Dec 11. | |
| 37211991 |
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the study protocol, statistical analysis plan, informed consent form, clinical study report would be available upon email request in 3 years after the closure of the study
3 years after the closure of the study
upon email request
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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| ID | Term |
|---|---|
| C000720108 | glofitamab |
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| ORR | overall response rate | 6 weeks, 18 weeks, 36 weeks |
| DOR | duration of response | 2 year |
| AE | Rate and type of adverse events (AEs) and serious adverse events (SAEs) | 2 year |
| Background |
| Birtas Atesoglu E, Gulbas Z, Uzay A, Ozcan M, Ozkalemkas F, Dal MS, Kalyon H, Akay OM, Deveci B, Bekoz H, Sevindik OG, Toptas T, Yilmaz F, Koyun D, Alkis N, Alacacioglu I, Sonmez M, Yavasoglu I, Tombak A, Mehtap O, Kurnaz F, Yuce OK, Karakus V, Turgut M, Kurekci DD, Ayer M, Keklik M, Buyuktas D, Ozbalak M, Ferhanoglu B. Glofitamab in relapsed/refractory diffuse large B-cell lymphoma: Real-world data. Hematol Oncol. 2023 Oct;41(4):663-673. doi: 10.1002/hon.3174. Epub 2023 May 22. |
| 37855035 | Background | Song YQ, Zhang HL, Huang HQ, Zhang QY, Jing HM, Wang C, Wu C, Li DH, Dai Y, Humphrey K, Zhu J. Glofitamab monotherapy induces high complete response rates and manageable safety in Chinese patients with heavily pretreated relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2024 Apr 1;109(4):1269-1273. doi: 10.3324/haematol.2023.283802. No abstract available. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |