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Chidamide with Rituximab for Relapsed/Refratory Germinal Center subtype of Diffuse Large B Cell Lymphoma

Chidamide with Rituximab for Relapsed/Refratory Germinal Center subtype of Diffuse Large B Cell Lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16008628
Enrollment
Unknown
Registered
2016-06-12
Start date
2016-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Germinal center subtype of Diffuse Large B Cell Lymphoma

Interventions

one :Chidamide with Rituximab

Sponsors

Qilu Hospital, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Diffused large B cell lymphoma diagnosed with pathological evidence, and verified to be GCB subtype with immunohistochemistry, refractory DLBCL means cases that are non-responsive or even with progression after 2 standard course of CHOP with/without Rituximab; relapsed DBLCL is diagnosed with the criteria in Appendix 1; (2) Aged 18-75 years old; (3) KPS>80 (4) Expected overall survival> 3 months; (5) Clinically measurable or accessible foci should present, measurable foci are defined as foci that are clear in imaging examination with measurable double diameters (>=1cm×1cm on CT or MRI, >=2cm×2cm in physical examination or ultrasonography), accessible foci are defined as foci that only have single measurable diameter; (6) The value of biomarkers of hepatic and renal function (like bilirubinserum creatinin) is under twice of the normal value; (7) Heart function: no obvious or uncontrollable heart disease, no myocardial infarction in the past 6 months, no obvious congestive heart failure, no obvious supra-ventricular or ventricular arrhythmias, no grade II or III conduction block, no acute myocardial ischemia or QT interval elongation; (8) Pulmonary function: no uncontrollable pulmonary function disorder; (9) Patients must sign the written consent before inclusion and they should be able to implement the consent physiologically and emotionally.

Exclusion criteria

Exclusion criteria: (1) With active infection; (2) With metastatic brain diseasesevere brain disease or mental disorders that can influence the patients private prosecution; (3) With other malignant tumors that have not been effectively controlled; (4) Women in pregnancy or lactation, and those with fertility but are not willing to employ effective contraceptives or their spouses are not willing to employ effective contraceptives; (5) Has taken part in other clinical trials within the past 4 weeks; (6) With thrombosis history; (7) With other conditions that the researchers think are not appropriate for the trial.

Design outcomes

Primary

MeasureTime frame
Imagine (tumor size);tumor marker;

Secondary

MeasureTime frame
history;physical examination;Blood routine test;

Countries

China

Contacts

Public ContactMing Hou

Departments of Hematology, Qilu hospital, Shandong University

drhouming@163.com+86 15821531560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026