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Bendamustine Convert Study

Phase 2 study of BR therapy for CD20-positiveuntreated and advanced follicular lymphoma with poor response to R-CHOP therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051180181
Enrollment
60
Registered
2019-03-26
Start date
2013-06-26
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

Follicular Lymphoma

Interventions

6cycles BR treatment for patients who have refractory for 2cycles R-CHOP

Sponsors

Tatsumi Yoichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Progression free survival

Secondary

MeasureTime frame
Overall response rate, CR rate, safety, prognostic factor, Overall Survival, histological transformation.

Contacts

Public ContactShinya Rai

Kindai University Hospital

rai@med.kindai.ac.jp+81-72-366-0221

Outcome results

None listed

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