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This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YY-20394 combined with GEMOX second-line or above in patients with relapsed and/or refractory diffuse large B-cell lymphoma.
YY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards.
This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YY-20394 combined with GEMOX second-line or above in patients with relapsed and/or refractory diffuse large B-cell lymphoma.
YY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards.
The first six subjects of group to evaluate the safety of YY - 20394 joint GEMOX, if the joint treatment of 6 cases of subjects before, If YY-20394 and/or chemotherapy related 4 degrees of hematology toxicity or level 3 non hematologic toxicity were appearanced less than 2 cases, continued to dose of 80 mg/day, if more than 2 cases, YY-20394 doses dropped to 60 mg/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YY-20394 | Experimental | YY-20394 tablets will be given daily for 21 days in 21-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YY-20394 | Drug | Yy-20394 combined with Gemcitabine and Oxaliplatin was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of Gemcitabine and Oxaliplatin was treated according to clinical standards. |
| Measure | Description | Time Frame |
|---|---|---|
| objective remission rate | Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria | with in 42 days after the first dos |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate | Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria | with in 42 days after the first dos |
| Progression Free Survival |
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Inclusion Criteria:
- Patients with recurrent and/or refractory diffuse large B-cell lymphoma confirmed histologically or cytologically; Progress after first-line or above systemic treatment (at least CD20 monoclonal antibody treatment); ECOG Performance Status (PS) grade 0 ~ 1; Expected survival ≥3 months; The patient has at least one measurable lesion conforming to the IWG2007 standard; Good organ function level:ANC≥1.0×109/L;PLT≥70×109/L;Hb≥80 g/L
;TBIL≤1.5×ULN; ALT和AST≤2.5×ULN;BUN/Urea和Cr≤1.5×ULN;LVEF≥50%; The Fridericia method corrected the QT interval (QTcF) for males < 450 ms and females < 470 ms.
From the end of any previous anti-tumor therapy (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy) to the washout period of this study ≥4 weeks; Did not participate in the clinical trial as a subject within 1 month before the trial; According to the researcher's judgment, it can comply with the experimental protocol; Volunteer to participate in this clinical trial, understand the study procedures and be able to sign the informed consent in person.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanying Bao, PHD | Contact | 86 21-5137069 | hybao@yl-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiming Li, PHD | Cancer Prevention center affiliated to Sun Yat-sen University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39923042 | Derived | Sun P, Cen H, Yang H, Huang R, Cai Z, Gu X, Bao H, Xu Z, Xu Z, Li ZM. PI3Kdelta inhibitor linperlisib combined with gemcitabine and oxaliplatin for relapsed or refractory diffuse large B-cell lymphoma: a multicenter, single-arm phase Ib/II trial. Cancer Cell Int. 2025 Feb 8;25(1):39. doi: 10.1186/s12935-025-03669-2. |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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YY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards
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|
Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria
| with in 42 days after the first dos |
| drug safety | Adverse events evaluated by NCI CTCAE v5.0 | one and half a year |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |