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A Clinical study for low dose Dectabine + R-CHOP treat diffuse large B cells lymphoma

A Clinical study for low dose Dectabine + R-CHOP treat diffuse large B cells lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900020916
Enrollment
Unknown
Registered
2019-01-22
Start date
2019-02-12
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Diffuse Large B Cells Lymphoma

Interventions

Group1:low dose Dac+R-CHOP
Group2:R-CHOP

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years with the expected survival period of greater than 3 months; 2. Recurrent refractory b-cell hematological disease diagnosed as CD20+; 3. Not suitable for the conditions of allogeneic stem cell transplantation or giving up allogeneic stem cell transplantation due to the restrictions of conditions; 4. Autologous hematopoietic stem cell transplantation after recurrence; 5. ECOG score is no more than 2 points (appendix 1); 6. PS score is 0~ 2 points; 7. NCCN-IPI score is =3 points( intermediate-or high risk score); 8. Adequate cardiac, hepatic and renal functions (heart: no heart disease or coronary heart disease, patients with grade 1-2 cardiac function (appendix 2); Liver: TBIL is less than or equal to 3ULN, AST is less than or equal to 2.5ULN, and ALT is less than or equal to 2.5ULN; Kidney: Cr = 1.25ULN; Peripheral blood: WBC = 2.5 x10^9/L, lymphocyte count: >0.5x10^9/L, Hb = 80 g/L, PLT = 60 x10^9/L),ALB = 35g/L; 9. Diagnosis of cerebrospinal fluid and brain mri: the leukemia cells did not invade the central nervous system; 10. Non-severe allergic constitution; 11. Other serious diseases (such as autoimmune diseases, immunodeficiency and organ transplantation) that do not conflict with the program; 12. No other history of malignancy; 13. Women of reproductive age must be tested for negative blood pregnancy test within 7 days, and subjects of reproductive age must use appropriate contraception during the test and within 3 months after the test; 14. The patient agrees to participate in this clinical study and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or lactating (women who are of childbearing age need to have a pregnancy test); 2. Severe infectious diseases or viral diseases (HIV positive, syphilis, etc.); 3. Active viral hepatitis b or c; 4. Patients who used a large amount of glucocorticoid within 1 week; 5. Suffering from serious heart, liver, renal insufficiency, diabetes and other diseases; 6. Patients without chemotherapy or hematopoietic stem cell transplantation within 3 months before blood collection; 7. Have participated in other clinical studies or been treated with other gene products in the past 3 months; 8. Serious mental disorders.

Design outcomes

Primary

MeasureTime frame
Efficacy;Safety;

Countries

China

Contacts

Public ContactKaiyang Ding

Anhui Provincial Cancer Hospital

dingkaiy@126.com+86 13966672170

Outcome results

None listed

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