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One arm prospective clinical study of zebutinib combined with R-CHOP regimen induced bridging autologous hematopoietic stem cell transplantation in the treatment of newly diagnosed extranodal diffuse large B-cell lymphoma

One arm prospective clinical study of zebutinib combined with R-CHOP regimen induced bridging autologous hematopoietic stem cell transplantation in the treatment of newly diagnosed extranodal diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053056
Enrollment
Unknown
Registered
2021-11-10
Start date
2021-11-11
Completion date
Unknown
Last updated
2022-09-06

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

Conditions

Lymphoma

Interventions

Experimental group:Bridging autologous hematopoietic stem cell transplantation induced by zebutinib combined with R-CHOP regimen

Sponsors

Chongqing University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The subject aged 18 to 70 years; 2. Extranodal diffuse large B-cell lymphoma confirmed by histopathology of the research center, including but not limited to stomach, intestine, liver, spleen, kidney, lung, bone, skin, testis, breast, or uterus, etc.; 3. Measurable lesions, extranodal lesions > 1cm; 4. IPI score > = 2 points; 5. Estimated survival time >= 6 months; 6. Liver function: AST and ALT = 3.0 x 10^9/L, ANC >= 1.5 x 10^9/L, PLT >= 75 x 10^9/L, Hb >= 90 g/L; 9. Cardiac function: LVEF >= 50% by echocardiography; 10. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with primary central nervous system lymphoma; 2. Serious diseases that may limit patients' participation in the trial (such as progressive infection, uncontrolled diabetes, uncontrolled hypertension, severe cardiac insufficiency or angina, liver and kidney dysfunction); 3. Have a history of other tumors, except for cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 4. Known infection history of human immunodeficiency virus (HIV) or infection with active hepatitis C virus (HCV) or hepatitis B virus (HBV). Active hepatitis B virus infection should be confirmed by HBV surface antigen test or hepatitis B core antibody test, and confirmed by polymerase chain reaction (PCR) as HBV DNA positive; 5. Have a serious history of neurological or mental illness, including dementia or epilepsy; 6. Have received chemotherapy for DLBCL, and have used BTK inhibitor or chop regimen in the past; 7. The researchers deemed unsuitable for the group.

Design outcomes

Primary

MeasureTime frame
Complete remission rate after 4 cycles;

Secondary

MeasureTime frame
Duration of remission;2-year progression free survival;2-year overall survival;

Countries

China

Contacts

Public ContactLiu Yao

Chongqing University Cancer Hospital

648283926@qq.com+86 13228684685

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026