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Spots Global Cancer Trial Database for YY-20394 、GEMOX Treatment Diffuse Large B-cell Lymphoma Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial

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Trial Identification

Brief Title: YY-20394 、GEMOX Treatment Diffuse Large B-cell Lymphoma Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial

Official Title: YY-20394 Combined With GEMOX in the Treatment of Patients With Relapsed and/or Refractory Diffuse Large B-cell Lymphoma With a Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial

Study ID: NCT04500561

Interventions

YY-20394

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Zhiming Li, PHD

Affiliation: Cancer Prevention center affiliated to Sun Yat-sen University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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