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A prospective, multicenter randomized phase III clinical trial of intensified chemotherapy in improving the treatment efficacy of patient with diffuse large B-cell lymphoma

A prospective, multicenter randomized phase III clinical trial of intensified chemotherapy in improving the treatment efficacy of patient with diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001687
Enrollment
Unknown
Registered
2011-11-01
Start date
2011-03-18
Completion date
Unknown
Last updated
2017-04-18

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

R-CHOP21:R-CHOP repeated in 21 days
R-CHOP14:R-CHOP repeated in 14 days

Sponsors

SUN YAT-SEN UNIVERSITY CANCER CENTER
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age >=18 years; 2) patients with histological confirmed, untreated, CD 20(+) diffuse large B cell lymphoma; 3) there are lesions can be measured and evaluated; 4) no previous treatments including radiotherapy, chemotherapy or surgery; 5) Normal haematological, liver and renal function (wbc>=3.5*10^9/l, hb>100g/l, plt>90*10^12/l); 6) ECOG performance status 0-3, life expectancy of at least 3 months; 7) no history of other malignancies; 8) no other seriuos diseasies which conflict with the treatment in the present trial; 9) no concurrent treatments that conflict with the treatments in the present trial(including steroid drugs); 10) patients should understand and are willing to participate in the trial. Inform consent form is supposed to obtained before treatment; 11) All patients should consent to adopt efficient contraception methods during the treatment and 6 months after the treatment. The pregnant tests of women who are in child bearing period should be negative before the treatment.

Exclusion criteria

Exclusion criteria: 1) Patients who participate in other clinical trials within 3 months; 2) Patients who have secondary lymphomas after chemotherapy or radiotherapy for other malignancies; 3) Those with transformed lymphomas; 4) Those with primary central nervous system lymphoma or testicular lymphoma; 5) History of allergic reaction to any ectogenic protein; 6) Previous treatments for lymphoma; 7) History of other malignancies; 8) Neutrophil count2*upper limit of normal); 12) Patients with Liver dysfunction unrelated to lymphoma (transaminase>=3*upper limit of normal, and/or bilirubin>=2.0/dl); 13) Patients with clinical symptoms related to brain dysfunction, or serious mental diseases; 14) Female patients who is pregnant or under breast-feeding.

Design outcomes

Primary

MeasureTime frame
disease free survival;

Countries

China

Contacts

Public ContactTongYu Lin
dgd@hotmail.com+86 13926400320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026