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

Phase 2

Completed

• Conditions: CD20 positive follicular lymphoma or diffuse large B-cell lymphoma.

• Registration Number: JPRN-jRCT2080223607
• Lead Sponsor: ZENYAKU KOGYO CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-01
• Study Completion: 2019-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 33

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 < 3 on the ECOG scale.
5. Patients between 20 and 80 years of age at registration.
6. Adequate organ function:
- Absolute Neutrophil Count (ANC) >= 1,500/mcl
- platelet count >= 100,000/mcl
- hemoglobin >= 8.0 g/L
- AST <= 3.0 x upper limit of normal
- ALT <= 3.0 x upper limit of normal
- bilirubin <= 2.0 mg/dL
- creatinine <= 2.0 mg/dL
- left ventricular ejection fraction >= 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
other<br>Feasibility and tolerability<br>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 Outcome Measures

Name	Time	Method
efficacy<br>Best Overall Response Rate, Complete Response Rate