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A multicenter, prospective, single-arm, phase II study for dexitabine combined with R-GDP regimen in the treatment of intermediate PET-CT positive newly diagnosed diffuse large B-cell lymphoma (DLBCL)

A multicenter, prospective, single-arm, phase II study for dexitabine combined with R-GDP regimen in the treatment of intermediate PET-CT positive newly diagnosed diffuse large B-cell lymphoma (DLBCL)

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000028858
Enrollment
Unknown
Registered
2020-01-05
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:D-R-GDP

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old, ECOG score 0-2, expected survival time > 12 weeks; 2. In patients with diffuse large B-cell lymphoma confirmed by histopathology, CD20 was positive. 3. There was no contraindication of chemotherapy: hemoglobin >=9.0g / L, absolute neutrophil count >=1500L, platelet >=100000L, alt, AST <=2 times normal upper limit, serum total bilirubin <=1.5 times normal upper limit. Serum creatinine <=1.5 times the normal upper limit; 4. At least one measurable lesion; 5. There were no other serious diseases conflicting with this scheme, and the cardiopulmonary function was basically normal; 6. Women of childbearing age were negative in urine or blood pregnancy test within 7 days. Male and female patients should agree to use effective contraceptive measures during treatment and in the following year; 7. Be able to understand this study and sign an informed consent form before screening.

Exclusion criteria

Exclusion criteria: 1. Patients without initial treatment or recurrence; 2. Double hit lymphoma; 3. Patients who had been treated with past aberrant methylation inhibitors; 4. With central nervous system (meninges or brain parenchyma) involved; 5. Patients who plan to receive subsequent autologous stem cell transplantation; 6. Refusing to provide blood or tissue specimens; 7. More than one chemotherapy regimen has been received in the past. 8. Peripheral neuropathy >=2 grade; 9. There are drug allergies or metabolic disorders to the drugs in this program; 10. Those who refuse to use reliable contraceptive methods during pregnancy, lactation or appropriate age; 11. There are any uncontrollable medical diseases (including uncontrolled diabetes, severe heart, lung, liver, renal insufficiency); twelve Patients with severe infection or active bleeding; 13. There are contraindications of chemotherapy or targeted therapy; 14. He has suffered from other malignant tumors in the past; 15. Mental disorders / persons who are unable to obtain informed consent; 16. The researchers determined that they were not suitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
CR;PR;ORR;PFS;OS;

Countries

China

Contacts

Public ContactLiling zhang

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

lily1228@sina.com+86 15871725926

Outcome results

None listed

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