Bendamustine Convert Study

JRCT ID: jRCTs051180181

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Follicular Lymphoma
• Date of first enrollment: 26/06/2013
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 6cycles BR treatment for patients who have refractory for 2cycles R-CHOP

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall response rate, CR rate, safety, prognostic factor, Overall Survival, histological transformation.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Advanced stage Follicular lymphoma (Ann Arbor stage 3/4or stage2 with bulky)
2. Patients must have histologically determined CD20+ follicular lymphoma, grade 1-3A, with pathologic review at the participating institutions
3. Measurable disease on CT scans of at least 1.5 cm
4. Age 18-85 years
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Adequate organ function
7.Patients without severe complications
8.Life expectancy at least 3months
9. Ability to understand and the willingness to sign a written informed consent document.

Exclude criteria

1.Active concurrent malignancy (except non-invasive non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia). If there is a history of prior malignancy, the patient must be disease-free for at least 5-years at the time of study entry.
2.Diabetes Patients who have been treated
3.Unstable or severe uncontrolled medical condition (e.g. unstable cardiac function, unstable pulmonary condition, unstable liver condition, unstable renal condition). History of tuberculosis.
4.Clinically significant cardiovascular abnormalities such as: history of stroke
5.History of interstitial pneumonia, radiation pneumonitis
6.absolute lymphoma cells in peripheral blood >25,000/microliter
7.Central nervous system lymphoma, including lymphomatous meningitis
8.History of anaphylactic shock
9.Increase the risk to the patient associated with Rituximab administration
10.Patients with severe mental disease
11.History of hematopoietic disorders
12.History of lymphoma treatment
13.Pregnant or nursing women
14.Patients with HIV positive
15.Any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his or her participation in the study

Related Information

• Primary Sponsor: Tatsumi Yoichi
• Source(s) of Monetary Support: Eisai Co., Ltd,Eisai Co., Ltd.