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

JRCT ID: jRCT2080223607

Registered date:01/08/2017

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: CD20 positive follicular lymphoma or diffuse large B-cell lymphoma.
• Date of first enrollment: 01/09/2017
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : IDEC-C2B8
INN of investigational material : Rituximab (genetical recombination)
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Patients will receive IDEC-C2B8 plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) for 6 or 8 cycles. [Rituximab] During Cycle 1, rituximab is diluted to a final concentration of 4 mg/mL and rituximab is administered at an initial rate of 50 mg/hr. The infusion rate is escalated by 50 mg/hr increments every 30 minutes to a maximum infusion rate of 400 mg/hr. If rituximab infusion in Cycle 1 was tolerated without grade 3/4 infusion reactions, subsequent rituximab infusions are administered over a total time of 90 minutes with a total diluted volume of 250 mL. [CHOP] Prednisolone was administered prior to rituximab infusion.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

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 Outcome

efficacy
Best Overall Response Rate, Complete Response Rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: ZENYAKU KOGYO CO., LTD.
• Secondary Sponsor: -
• Source(s) of Monetary Support: ZENYAKU KOGYO CO., LTD.
• Secondary ID(s): JapicCTI-173663