Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma

Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma - Study of efficacy and safety of reduced chemotherapy and risk evaluation of perforation by Endoscopy for gastrointestinal non-Hodgkin Lymphoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026100

Enrollment

Registered

2017-02-12

Start date

2016-09-07

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Gastrointestinal non-Hodgkin lymphoma

Interventions

Cyclophosphamide 525mg/m2 DIV Day1 Adriamycin or Therarubicin 35mg/m2 DIV Day1 Vincristine 1mg/m2(max 2mg)DIV Day1 Prednisolone Oral 100mg/body Day1-5 Rituximab DIV 375mg/m2 Day0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Newly non-Hodgkin lymphoma pts confirmed with histology. 2) It is possible to evaluate the digestive tract lesions (esophagus, stomach, duodenum, ileum, jejunum, colon) by endoscopy.3) Aged 18 or older. 4. ECOG performance status 0-2 5. Patients meet all following standard Absolute neutrophil count >= 1,000/mm3, Hemoglobin >= 8.0 g/dL, Platelet count >= 75,000/mm3, AST and ALT < 2.5 times facility criteria, Total bilirubin < 2.5 times facility criteria, Creatinine Clearance >= 30ml/min. 6.Written informed consent obtained.

Exclusion criteria

Exclusion criteria: 1) CNS involvement 2) Serologically positive for HIVAb 3) Perforation or penetration of the digestive tract before treatment 4) Severe infection or clinical complication 5) Pregnant, possible pregnant, or breastfeeding woman 6) Active malignancy concomitantly existed 7) Known allergy for study drugs 8) Known resistance for study drugs 9) Patients who have been judged by the investigator to be inappropriate for participation in this clinical trial for other reasons.

Design outcomes

Primary

Measure	Time frame
Success of the treatment rate	—

Secondary

Measure	Time frame
Overall response rate Complete response rate Overall survival Progression-free survival Safety Validity of evaluation of perforation by EUS	—

Countries

Japan

Contacts

Public ContactMasaya Kubota

Gifu University Department of Hematology

kubota-gif@umin.ac.jp058-230-6308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026