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A multi-center, prospective, single-arm, open label phase II trial for anlotinib combined with R-ICE regimen in the treatment of refractory/relapsed diffuse large B-cell lymphoma

A multi-center, prospective, single-arm, open label phase II trial for anlotinib combined with R-ICE regimen in the treatment of refractory/relapsed diffuse large B-cell lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028655
Enrollment
Unknown
Registered
2019-12-29
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Case series:Combined with anlotinib and R-ICE regimen

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, male or female; 2. Pathologically or cytologically confirmed patients with diffuse large B-cell lymphoma, CD20 positive with evidence of relapsed(reclapsed 3 months after induction of complete remission) or refractory (failure to achieve complete remission or disease progression in early remission (3 months) after repeated induction of chemotherapy); 3. ECOG status of 0,1 or 2; Life expectancy >12 weeks; 4. At least one measurable lesion that met IRWG criteria; 5. Patient or his/her legal representative should sign informed consent before any special examination or procedure.

Exclusion criteria

Exclusion criteria: 1. Previously received VEGFR inhibitors such as antinib, apatinib and bevacizumab; Previous hematopoietic stem cell transplantation; 2. Allergy to the study drug or any of its excipients; Or a severe allergic reaction to tyrosine kinase inhibitors; 3. Central nervous system lymphoma/leukemia status; 4. Diagnosed with any other malignant tumor within 3 years before entering the study, except basal cell carcinoma of the skin and in-situ cervical cancer; 5. Infiltration or failure of lymphoma bone marrow (neutrophils 150mmol/L, total bilirubin > 30mmol/L, transaminase level 2.5 times higher than the high limit of normal reference value, unless these abnormalities are associated with primary lymphoma); 6. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis; 7. Received radiotherapy within 4 weeks before treatment; 8. Have received any other clinical drug trial within 30 days before or during the whole trial; 9. Female patients during pregnancy or lactation; 10. Legal disability (blindness, deafness, deafness, mental retardation), mental illness.

Design outcomes

Primary

MeasureTime frame
Imaging methods (PET-CT, MRI or CT) detect tumor progression and remission;peripheral blood;bone marrow;

Countries

China

Contacts

Public ContactShi Jun

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

shijun@sjtu.edu.cn+86 13701867597

Outcome results

None listed

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