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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab and CHOP Combination Treatment | Active Comparator | Obinutuzumab: 1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6. CHOP: 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. Each cycle lasts 21 days, up to 6 cycles are administered. Then add 2 cycles of obinutuzumab monotherapy. |
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| Obinutuzumab and Bendamustine Combination Treatment | Experimental | Obinutuzumab: 1000mg i.v., administered on D1/8/15 of C1, and D1 of C2-6. Bendamustine: 90 mg/m2 i.v. drip, administered on D1-2. Each cycle lasts 28 days, up to 6 cycles are administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | 1000mg i.v., administered on Day 1/8/15 (D1/8/15) of Cycle 1 (C1), and D1 of C2-6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | From study entry to the first documented disease progression or death from any cause. | Assessed up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) | Defined as the proportion of patients who achieve complete remission at the end of induction therapy. | Up to 6 cycles (up to 24 weeks). |
| Objective Response Rate (ORR) | The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai | Contact | 0086-020-87342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 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. |
|
| Up to 6 cycles (up to 24 weeks). |
| 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. | Assessed up to 5 years. |
| Overall Survival (OS) | From study entry to death from any cause. | Assessed up to 5 years. |
| Progression of Disease within 24 months (POD24) | The occurrence of disease progression or relapse within 24 months from the date of enrollment. | 24 months. |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |