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A prospective randomized phase III clinical trail of aggressive field helical tomography (TOMO) combined with rituximab versus rituximab in stage III follicular lymphoma with complete remission

A prospective randomized phase III clinical trail of aggressive field helical tomography (TOMO) combined with rituximab versus rituximab in stage III follicular lymphoma with complete remission

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032550
Enrollment
Unknown
Registered
2020-05-02
Start date
2012-05-28
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

Follicular lymphoma

Interventions

Group 2:RTX 375 mg/m2, eight week once, total 12 times + aggressive field TOMO radiotherapy
Group 1:RTX 375 mg/m2, eight week once, total 12 times

Sponsors

Sun Yat-sen Uncersity Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old; 2. Histopathological confirmation of CD20 (+) follicular lymphoma, grade 1,2 or 3a; 3. Ann Arbor stage III; 4. life expectancy >=3 months; 5. CR efficacy was obtained by imaging evaluation after first-line chemotherapy before enrollment; 6. Normal organ function: blood routine, liver and kidney function is normal (WBC>=3.5x10^9/L, ANC>=2.0x10^9/L, HGB > 100 g/L, PLT > 90x10^12/L, ALT, AST < 2.5ULN); 7. No other anti-tumor treatment (including traditional Chinese medicine, Chinese patent medicine and steroid drugs with anti-tumor effect); 8. Understand and voluntarily participate in the experiment, and sign the informed consent; 9. The urine pregnancy test was negative in women of childbearing age before treatment, and all enrolled patients had to agree to avoid pregnancy during the study period and 6 months after discontinuation of treatment.

Exclusion criteria

Exclusion criteria: 1. Participated in other clinical trials in the last 3 months; 2. Grade 3b follicular lymphoma; 3. Ann Arbor stage I/II or IV; 4. Serious mental illness; 5. Primary testicular lymphoma; 6. Rituximab allergy; 7. Previous or concurrent combination of other malignant tumors, except for the cured basal cell carcinoma; 8. Active infections that require treatment; 9. Organ dysfunction, such as: malignant hypertension, heart failure, dilated cardiomyopathy, unstable angina or myocardial infarction within 6 months, renal insufficiency (Cr > 1.5 ULN), liver dysfunction (AST/ALT > 2.5ULN, or BIL > 2.0mg/dl); 10. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Disease free 5 years survival;

Countries

China

Contacts

Public ContactTongyu Lin

Sun Yat-sen Uncersity Cancer Center

linty@sysucc.org.cn+86 13926400320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 29, 2026