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Alkylating agents

Zanubrutinib for Non-Hodgkin's 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

Study 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.Check my eligibility
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).See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Number of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP) cycles received
Objective response rate (ORR)
Overall survival (OS)
+7 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%
Pyrexia
10%
Thrombocytopenia
10%
Nausea
10%
Contusion
10%
Cough
10%
Headache
8%
Pneumonia
8%
Vomiting
8%
Urinary tract infection
7%
Epistaxis
7%
Pain in extremity
7%
Peripheral swelling
7%
Constipation
7%
Oedema peripheral
7%
Back pain
7%
Dizziness
6%
Dyspepsia
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
Hyperuricaemia
6%
Decreased appetite
6%
Bronchitis
5%
Abdominal pain
5%
Fall
5%
Hypokalaemia
5%
Insomnia
5%
Petechiae
4%
Palpitations
4%
Blood pressure increased
4%
Dyspnoea
4%
Gastrooesophageal reflux disease
4%
COVID-19 pneumonia
4%
Cellulitis
4%
Haematuria
4%
Sinusitis
4%
Alanine aminotransferase increased
4%
Weight decreased
4%
Haematoma
4%
Oral herpes
4%
Myalgia
4%
Squamous cell carcinoma of skin
3%
Nasopharyngitis
3%
Gout
3%
Basal cell carcinoma
3%
Oropharyngeal pain
3%
Anxiety
3%
Paronychia
3%
Skin infection
3%
Paraesthesia
3%
Conjunctivitis
3%
Mouth ulceration
3%
Asthenia
3%
Pharyngitis
3%
Aspartate aminotransferase increased
3%
Productive cough
2%
Vertigo
2%
Herpes zoster
2%
Cataract
2%
Blood creatinine increased
2%
Pruritus
2%
Rash maculo-papular
2%
Hypogammaglobulinaemia
1%
Cerebral infarction
1%
Cardiac arrest
1%
Transient ischaemic attack
1%
Adenocarcinoma gastric
1%
Respiratory failure
1%
Syncope
1%
Lung adenocarcinoma
1%
Death
1%
Pleural effusion
1%
Abdominal pain upper
1%
Influenza
1%
Hypoglobulinaemia
1%
Lymphadenopathy
1%
Angina pectoris
1%
Ventricular fibrillation
1%
Inguinal hernia
1%
Appendicitis
1%
Infection
1%
Mastoiditis
1%
Pneumocystis jirovecii pneumonia
1%
Septic shock
1%
Haemolytic anaemia
1%
Subdural haematoma
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Myocardial infarction
1%
Skin laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrutinib
Zanubrutinib

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
~2370
Rituximab
1999
Completed Phase 4
~1880
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Vincristine Sulfate
2005
Completed Phase 3
~10110
Cyclophosphamide
1995
Completed Phase 3
~3770
Zanubrutinib
2017
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

Yazeed SawalhaLead Sponsor
1 Previous Clinical Trials
Yazeed Sawalha, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Zanubrutinib a validated pharmaceutical agent according to the US Food and Drug Administration?

"Since this is the first phase of clinical trials for Zanubrutinib, there's only minimal data proving its efficacy and safety; thus it was assigned a rating of 1."

Answered by AI

Could you provide information on the previous experiments with Zanubrutinib?

"The current number of clinical trials researching Zanubrutinib is 1523, with 334 in the advanced Phase 3 stage. Although Bethesda Maryland has a high concentration of research sites, there are 55606 medical centres around the world conducting these studies."

Answered by AI

How many individuals have been enrolled in the experiment thus far?

"Affirmative, the details available on clinicaltrials.gov indicate that this trial is seeking participants. Initiated on November 16th 2021 and last amended in February 23rd 2022, 24 volunteers must be sourced from a single medical site for this research endeavour."

Answered by AI

Is enrollment still feasible for those interested in participating?

"According to data accessible on clinicaltrials.gov, this medical trial is still in search of participants for the study that was originally posted on November 16th 2021 and last updated February 23rd 2022."

Answered by AI

What ailments is Zanubrutinib commonly prescribed to address?

"Zanubrutinib is widely employed to treat pheochromocytomas, as well as ulcerative colitis, varicella-zoster virus acute retinal necrosis and multiple myeloma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Zanubrutinib in Combination With R-CHOP (ZaR-CHOP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma
Yazeed Sawalha 2021. "Zanubrutinib in Combination With R-CHOP (ZaR-CHOP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04850495.
All > Marginal Zone Lymphoma
~5 spots leftby Dec 2024
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