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Immunomodulatory Agent

Zanubrutinib + Anti-CD20 for Lymphoma (MAHOGANY Trial)

Phase 3

Recruiting

Led By Study Director

Research Sponsored by BeiGene

Eligibility Criteria Checklist

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

Must have

Need for systemic therapy for FL or MZL

Previously received ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 87 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two different drug combinations in people with a certain type of lymphoma that has come back or does not respond to treatment.

Who is the study for?

This trial is for adults with relapsed/refractory Follicular or Marginal Zone Lymphoma who've had at least one prior treatment including an anti-CD20 agent but didn't respond well. They must have measurable disease and good bone marrow, liver, and kidney function.

What is being tested?

The study compares two treatments: Zanubrutinib plus Obinutuzumab versus Lenalidomide plus Rituximab. It measures which is better at stopping the lymphoma from progressing using PET/CT scans for Follicular Lymphoma and CT scans for Marginal Zone Lymphoma.

What are the potential side effects?

Possible side effects include reactions to infusions, blood disorders, infections due to a weakened immune system, fatigue, digestive issues like nausea or diarrhea, skin rashes, and potential impact on liver or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need medication for my follicular lymphoma or marginal zone lymphoma.

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I've had treatment including an anti-CD20 agent but my cancer did not improve or got worse.

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My cancer is a type of lymphoma confirmed by tissue analysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 87 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 87 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 87 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L)

HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18)

Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30)

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Marginal Zone Lymphoma Arm C: Zanubrutinib plus RituximabExperimental Treatment2 Interventions

Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.

Group II: Follicular Lymphoma Arm A: Zanubrutinib plus ObinutuzumabExperimental Treatment2 Interventions

Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.

Group III: Marginal Zone Lymphoma Arm D: Lenalidomide plus RituximabActive Control2 Interventions

Participants will receive lenalidomide and rituximab.

Group IV: Follicular Lymphoma Arm B: Lenalidomide plus RituximabActive Control2 Interventions

Participants will receive lenalidomide and rituximab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990