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:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year; |
|
| Measure | Description | Time Frame |
|---|---|---|
| CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV) | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria | From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response rate after induction by investigator (INV) | ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV according to 2014 Lugano criteria | From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days) |
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Inclusion criteria.
Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a
Have had no prior systemic treatment for lymphoma
Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment
18-75 years old.
ECOG Performance Status of 0-2 within 10 days prior to registration.
Stage II, III, or IV by Ann Arbor staging system.
defined as Intermediate-high risk by the follicular lymphoma international prognostic index (FLIPI) 1 or FLIPI 2.
Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study and for 3 months after the last dose of study drug(s). See the protocol.
Life expectancy ≥6 months
Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huilai Zhang, MD,PhD | Contact | 0086-22-23359337 | info@tjmuch.com |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C543332 | obinutuzumab |
| D011241 | Prednisone |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Obinutuzumab | Drug | Induction treatment: Obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-4/6); for 4-6 cycles, 1 cycle = 28 days Maintenance: Obinutuzumab (G), 1000mg, IV, every 2 months for 1 year; |
|
| Prednisone | Drug | Prednisone (P), 100 mg, PO, D2-6;for 4-6 cycles for CHOP treatment , 1 cycle = 28 days |
|
| Cyclophosphamide | Drug | Cyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days |
|
| Vincristine | Drug | Vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days |
|
| Doxorubicin | Drug | Doxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ,1 cycle = 28 days |
|
| Overall survival (OS) |
Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause |
| From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years |
| Progression free survival (PFS) | -PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV | From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |