Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma

NCT04899570 | Unknown Phase 2

• 1 other identifier: PUMCH-NHL-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of zanubrutinib combined with R-CHOP regimen in newly diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.

Conditions

Intravascular Large B-Cell Lymphoma

Keywords

Intravascular Large B-Cell Lymphoma; zanubrutinib; R-CHOP

Outcome Measures

Primary Outcomes (1)

• 2 years progression-free survival

  2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing.

  from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma

Secondary Outcomes (1)

• overall response rate(ORR)

  6 weeks after the end of 8 cycles of induction (each cycle is 21 days).

Study Arms (1)

Zanubrutinib combined with R-CHOP

EXPERIMENTAL

The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens. After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.

Drug: Zanubrutinib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vindesine; Drug: Prednisone

Interventions

Zanubrutinib DRUG

160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.

Also known as: BRUKINSA

Zanubrutinib combined with R-CHOP

Rituximab DRUG

Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol

Also known as: Rituxan

Zanubrutinib combined with R-CHOP

Cyclophosphamide DRUG

Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol

Zanubrutinib combined with R-CHOP

Epirubicin DRUG

Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol

Zanubrutinib combined with R-CHOP

Vindesine DRUG

Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Zanubrutinib combined with R-CHOP

Prednisone DRUG

Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Zanubrutinib combined with R-CHOP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteered to participate in the study and signed the Informed Consent
• Age ≥18 years old ≤70 Years old, male or female
• Expected survival ≥ 12 weeks
• Intravascular large B-cell lymphoma confirmed by cytology or histology according to WHO2016 criteria
• Never received any anti-tumor therapies.
• Adequate organ function and adequate bone marrow reserve

You may not qualify if:

• Malignant tumors other than IVLBCL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
• Active HIV, HBV, HCV or treponema pallidum infection
• Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
• Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

zanubrutinib; Rituximab; Cyclophosphamide; Epirubicin; Vindesine; Prednisone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Daobin Zhou

  Department of Hematology, Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Hui Xu

CONTACT

+861069156874; pumchkyc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2025
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

CN (1)