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Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A

ConditionFollicular Lymphoma Grade 3A
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed follicular lymphoma Grades 3A, CD20 positive by immunohistochemistry.

Meets at least one GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.

No prior systemic treatment for lymphoma.

Presence of measurable lesions.

Disqualifiers

History of allergy to any component of monoclonal antibodies or investigational drugs.

Central nervous system involvement.

History of previous malignant tumors.

History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obinutuzumab

    Drug

    1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6

  • CHOP

    Drug

    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.

  • Bendamustine

    Drug

    90 mg/m2 i.v. drip, administered on D1-2.

Treatment groups

133 Participants
are divided into 2 treatment groups
Group A: Obinutuzumab and CHOP Combination TreatmentActive comparator 2 interventions
Group B: Obinutuzumab and Bendamustine Combination TreatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

From study entry to the first documented disease progression or death from any cause.

Time frame
Assessed up to 5 years.

Secondary outcomes

1

Complete Response (CR)

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).
2

Objective Response Rate (ORR)

The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.

Time frame
Up to 6 cycles (up to 24 weeks).
3

Event-Free Survival (EFS)

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.
4

Overall Survival (OS)

From study entry to death from any cause.

Time frame
Assessed up to 5 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: