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The safety and feasibility of R2-CHOP with intensive central system prophylaxis and scrotal irradiation for newly diagnosed primary diffuse large B cell lymphoma of the testis

Combination of R2-CHOP and high-dose MTX for newly diagnosed primary diffuse large B cell lymphoma of the testis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027230
Enrollment
Unknown
Registered
2019-11-05
Start date
2020-01-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

primary testicular diffuse large B cell lymphoma

Interventions

Case series:intensive CNS prophylaxis

Sponsors

West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 15-75 years; 2. Newly diagnosed and untreated primary testicular diffuse large B cell lymphoma; 3. Orchiectomy is performed and within 2 months before study enrollment; 4. Ann Arbor Stage IE and IIE; 5. Hematological counts: ANC > 1.5 x 10^9/L and PLTs count > 75 x 10^9/L; 6. Cardiac ejection fraction >=45% by echocardiography; 7. No underlying disease that may preclude chemotherapy; 8. Conjugated bilirubin =45 ml/min; 11. HIV and HCV negativity; 12. No signs of active chronic hepatitis B; 13. Life expectancy > 6 months; 14. Performance status < 2 according to ECOG scale; 15. Understanding the trial and writing informed consent.

Exclusion criteria

Exclusion criteria: 1. Secondary testicular lymphoma; 2. CNS involvement by lymphoma; 3. History of other malignant diseases with the exception of patients with complete remission >=5 years; 4. Post-transplant lymphoproliferative disorders; 5. Hypersensitivity or intolerance to any agent of chemotherapy; 6. Liver or renal insufficiency or other diseases that preclude chemotherapy; 7. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of entry, New York Heart Association (NYHA) Class III or IV heart failure; 8. Uncontrolled hypertension or diabetes; 9. Have participated in other clinical trial.

Design outcomes

Secondary

MeasureTime frame
relapse rate in CNS;progress-free survival;Overall survival;

Primary

MeasureTime frame
safety;feasibity;

Countries

China

Contacts

Public ContactHongbing Ma

West China Hospital, Sichuan University

hongbingma@foxmail.com+86 18980605801

Outcome results

None listed

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