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

Phase 2
Recruiting
Conditions
Follicular lymphoma
D008224
Registration Number
JPRN-jRCTs031220727
Lead Sponsor
Honda Akira
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
20
Inclusion 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

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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