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Alkylating agents

Zanubrutinib + R-CHOP for Diffuse Large B-Cell Lymphoma

Phase 1

Recruiting

Led By Yazeed Sawalha, MD

Research Sponsored by Yazeed Sawalha

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding zanubrutinib to R-CHOP can help patients with newly diagnosed DLBCL and what the best dose of zanubrutinib is. Zanubrutinib is designed to block a protein called Bruton Tyrosine Kinase in order to stop cancer growth. R-CHOP is the acronym for the combination of five drugs: rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone.

Who is the study for?

Adults (18+) with newly diagnosed diffuse large B-cell lymphoma can join this trial if they have a performance status of <=2, meaning they're able to carry out daily activities with some effort. They need normal blood counts and organ function, must not be pregnant or breastfeeding, agree to use contraception, and cannot have other serious health issues that could interfere with the study.

What is being tested?

The trial is testing Zanubrutinib combined with R-CHOP chemotherapy regimen for treating patients with DLBCL. It aims to determine the best dose and assess potential benefits or side effects. R-CHOP includes rituximab (immunotherapy), cyclophosphamide, doxorubicin, vincristine (chemotherapies), and prednisone (steroid).

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever or chills; low blood cell counts leading to increased infection risk; nausea; hair loss from chemotherapy drugs; heart problems due to doxorubicin; nerve damage from vincristine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Objective response rate (ORR)

Overall survival (OS)

Progression-free survival

+2 more

Side effects data

From 2024 Phase 3 trial • 652 Patients • NCT03734016

24%

Diarrhoea

20%

Hypertension

18%

Neutropenia

16%

COVID-19

16%

Arthralgia

15%

Anaemia

14%

Upper respiratory tract infection

13%

Muscle spasms

13%

Fatigue

12%

Rash

11%

Atrial fibrillation

10%

Thrombocytopenia

10%

Nausea

10%

Pyrexia

10%

Contusion

10%

Cough

10%

Headache

Pneumonia

Vomiting

Urinary tract infection

Pain in extremity

Epistaxis

Peripheral swelling

Constipation

Oedema peripheral

Back pain

Dizziness

Dyspepsia

Neutrophil count decreased

Platelet count decreased

Hyperuricaemia

Decreased appetite

Bronchitis

Petechiae

Abdominal pain

Fall

Hypokalaemia

Insomnia

Palpitations

Blood pressure increased

Dyspnoea

Gastrooesophageal reflux disease

COVID-19 pneumonia

Cellulitis

Haematuria

Sinusitis

Alanine aminotransferase increased

Weight decreased

Haematoma

Oral herpes

Myalgia

Squamous cell carcinoma of skin

Basal cell carcinoma

Anxiety

Nasopharyngitis

Gout

Oropharyngeal pain

Paronychia

Skin infection

Paraesthesia

Conjunctivitis

Mouth ulceration

Asthenia

Pharyngitis

Aspartate aminotransferase increased

Productive cough

Vertigo

Pruritus

Herpes zoster

Cataract

Blood creatinine increased

Rash maculo-papular

Hypogammaglobulinaemia

Pleural effusion

Mastoiditis

Transient ischaemic attack

Abdominal pain upper

Death

Adenocarcinoma gastric

Lung adenocarcinoma

Cerebral infarction

Syncope

Cardiac arrest

Respiratory failure

Influenza

Hypoglobulinaemia

Lymphadenopathy

Angina pectoris

Ventricular fibrillation

Inguinal hernia

Appendicitis

Infection

Pneumocystis jirovecii pneumonia

Septic shock

Haemolytic anaemia

Subdural haematoma

Acute kidney injury

Acute respiratory failure

Myocardial infarction

Skin laceration

100%

80%

60%

40%

20%

Study treatment Arm

Ibrutinib

Zanubrutinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (zanubrutinib, R-CHOP)Experimental Treatment6 Interventions

Patients receive zanubrutinib PO on days 1-21, rituximab IV on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Rituximab

1999

Completed Phase 4

~2990