Japanese phase II study in untreated patients with CD20 positive B-cell non-Hodgkin's lymphoma evaluating safety of 90-minute infusion of rituximab.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223607

Enrollment

Registered

2017-08-01

Start date

2017-09-01

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

CD20 positive follicular lymphoma or diffuse large B-cell lymphoma.

Interventions

investigational material(s) Generic name etc : IDEC-C2B8 INN of investigational material : Rituximab (genetical recombination) Therapeutic category code : 429 Other antitumor agents Dosage and Adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. CD20 positive follicular lymphoma or diffuse large B-cell lymphoma confirmed according to WHO 2008 classification and patients can receive R-CHOP therapy. 2. Patients previously untreated with chemotherapy immunotherapy, immunochemotherapy, immunoradiotherapy or hematopoietic stem cell transplantation. 3. Life expectancy >= 6 months. 4. Performance status = 1,500/mcl - platelet count >= 100,000/mcl - hemoglobin >= 8.0 g/L - AST = 50% - oxygen saturation (SpO2) >= 96% 7. Hospitalization. The day of rituximab administration in Cycle 1, and the day of the first rituximab 90 minutes administration. 8. Patients who signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. With a history of other monoclonal antibody treatment. 2. Have participated in other clinical trial(s) for unapproved agent or treated with unapproved indication within 6 months prior to registration. 3. Who received G-CSF or other hematopoietic cytokine within one week prior to trial entry. 4. With a history of sensitive or allergic to murine-derived materials. 5. Having received major surgery (excluding lymph node biopsy) within 4 weeks prior to trial entry. 6. Tumor cells in peripheral blood > 10,000/mcl. 7. Positive HIV antibody. 8. Active hepatitis. Positive HBV serology positive (i.e., HBs antigen or HBs antibody positive), or positive HCV antibody within 4 weeks prior to trial entry. 9. Clinically significant heart failure, grade 3 or 4 a ventricular arrhythmia within one year prior to trial entry, or NYHA class II or greater heart failure. 10. Patients with infections or serious underlying medical conditions which could impair the ability of the patient to participate in the trial. 11. Diabetic patients who have treated with drugs. 12. Patients with malignant (except B-cell non-Hodgkin's lymphoma) within 2 years prior to trial entry. 13. Presence or history of CNS lymphoma infiltration. 14. Serious psychological disorders. 15. Pregnant or breast-feeding women. 16. Women and men who do not agree to use effective contraception during participation in the trial and for 12 months thereafter. 17. Patients who have participated in a study or a research of other investigational drug at screening. 18. In the opinion of the investigator, patients are unsuitable for any reasons.

Design outcomes

Primary

Measure	Time frame
other Feasibility and tolerability Percentage of patients who developed grade 3 or 4 infusion reactions resulting from 90-min infusion of rituximab during days 1 and 2 of cycle 2	—

Secondary

Measure	Time frame
efficacy Best Overall Response Rate, Complete Response Rate	—

Countries

Japan

Outcome results

None listed

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