The significance of reduced-dose bendamustine in elderly with follicular lymphoma

JRCT ID: jRCTs031220727

Registered date:24/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Follicular lymphoma
• Date of first enrollment: 24/03/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Treatment consists of 6 x 28 day cycles of obinutuzumab and bendamustine as follows:
- Obinutuzumab is administered at a dose of 1000mg on Day 1, 8 and Day 15 of the first 28 day treatment cycle. For cycles 2-6, obinutuzumab is administered at a dose of 1000mg on Day 1 of every 28 day treatment cycle.
- Bendamustine is administered at a dose of 60mg/m2 on Day 1 and Day 2 of each 28 day cycle.

Outcome(s)

• Primary Outcome: Overall response rate

Secondary Outcome

1. Safety (incidence of adverse events of grade 3 or more)
2. Progression free survival and overall survival
3. Progression of disease within 24 months

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Histologically diagnosed with CD20-positive follicular lymphoma (except for grade 3b)
2. Without having received chemotherapy, molecular targeted therapy, or radiation therapy for follicular lymphoma
3. Aged 70 years and above at the time of informed consent
4. Male or female
5. Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation
6. Able to attend all scheduled visits

Exclude criteria

1. With severe liver failure, renal failure, or cardiac disease (judged by CTCAE v5.0-JCOG grade 3)
2. Having received systemic chemotherapy for malignancy except for follicular lymphoma in 4 weeks before informed consent
3. With uncontrolled cancer except for follicular lymphoma
4. With a history of allergy to components of bendamustine or obinutuzumab
5. With a history of severe drug allergy including anaphylactic shock, or a history of severe side effects
6. Having taken study drugs in other clinical trials in 4 weeks before informed consent
7. Scheduled to receive chemotherapy or radiation therapy between the informed consent and the end of this trial
8. Judged as ineligible by clinical investigators

Related Information

• Primary Sponsor: Honda Akira