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Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma

ConditionFL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

: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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Known active central nervous system lymphoma or leptomeningeal disease

Evidence of diffuse large B-cell transformation

Grade 3b FL

Concurrent malignancy or malignancy within the last 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanubrutinib

    Drug

    Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year;

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment armExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)

Secondary outcomes

1

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

Time frame
From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)
2

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

Time frame
From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years
3

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

Time frame
From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

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