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Single center, open and single arm clinical study on the safety and efficacy of r2-mtx-epoch regimen in the treatment of CD5 positive diffuse large B cell lymphoma

Single center, open and single arm clinical study on the safety and efficacy of r2-mtx-epoch regimen in the treatment of CD5 positive diffuse large B cell lymphoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042633
Enrollment
Unknown
Registered
2021-01-24
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

DLBCL

Interventions

experimental group:Rituximab combined with lenalidomide, etoposide, methotrexate, vincristine, adriamycin, cyclophosphamide, prednisone

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The first diagnosis of CD5 + DLBCL (except primary mediastinal large B-cell lymphoma, primary central lymphoma, HIV related lymphoma) confirmed by pathological tissue, the diagnosis standard is in accordance with who 2008. 2. Aged <= 70 years with ECoG PS <= 2 points; 3. The expected service life is more than 3 months; 4. Ann Arbor stage I-IV; 5. There are follow-up conditions. The patients knew the characteristics of the disease, and voluntarily joined the study program for treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1. The patients with abnormal liver and kidney function, specifically the direct bilirubin, indirect bilirubin and / or alanine aminotransferase, glutamic oxaloacetylase, serum creatinine > 2 * normal value, unless the abnormal liver and kidney function is identified as related to lymphoma; 2. In patients with bone marrow failure, the specific definition is absolute neutrophil count (ANC) 1 * 10^4 copies / ml) and hepatitis C patients; 6. Lymphoma has been proved to involve the central nervous system; 7. Other malignant tumors other than lymphoma are diagnosed or under treatment, except for the following: (1) It has been treated for the purpose of cure, and there was no known active disease of malignant tumor at least 5 years before the group was enrolled; (2) Basal cell carcinoma of the skin (excluding melanoma) that has been treated well and shows no signs of disease; (3) Cervical carcinoma in situ, which has been fully treated and shows no signs of disease. 8. At the same time, they have other blood system diseases (such as hemophilia, myelofibrosis, etc.), which the researchers think are not suitable for the candidates; 9. Serious infection; 10. The patients were operated on at least level 2 within 3 weeks before the treatment; 11. Drug abuse, medical, psychological or social conditions that may interfere with subjects' participation in the study or evaluation of the results of the study; 12. The researchers think it is not suitable for the participants; 13. Those who are known to be allergic to the ingredients of the test drug.

Design outcomes

Primary

MeasureTime frame
CRR;

Secondary

MeasureTime frame
ORR;OS;PFS;

Countries

China

Contacts

Public ContactWei Sang

The Affiliated Hospital of Xuzhou Medical University

sw1981726@126.com+86 13645207648

Outcome results

None listed

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