Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
NCT Number: NCT06961500
This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6
a) Cyclophosphamide: 750 mg/m2 i.v. drip, administered on D1; b) Doxorubicin: 50 mg/m2 i.v. drip (or Epirubicin: 70mg/m2 i.v. drip), administered on D1; c) Vincristine: 1.4 mg/m2 i.v., administered on D1; d) Prednisone: 100mg/d po, administered on D1-5.
90 mg/m2 i.v. drip, administered on D1-2.
Time frame: Assessed up to 5 years.
From study entry to the first documented disease progression or death from any cause.
Time frame: Up to 6 cycles (up to 24 weeks).
Defined as the proportion of patients who achieve complete remission at the end of induction therapy.
Time frame: Up to 6 cycles (up to 24 weeks).
The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.
Time frame: Assessed up to 5 years.
From study entry to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason.
Time frame: Assessed up to 5 years.
From study entry to death from any cause.
Time frame: 24 months.
The occurrence of disease progression or relapse within 24 months from the date of enrollment.
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
A Multicenter, Phase 2, Randomized Trial of Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A (FL)
Acronym: PROOF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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