← Back to Search

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
Adequate bone marrow, liver and renal function
Need for systemic therapy for FL or MZL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 87 months
Awards & highlights

MAHOGANY Trial 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.Check my eligibility
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.See study design
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.

MAHOGANY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bone marrow, liver, and kidneys are functioning well.
Select...
I need medication for my follicular lymphoma or marginal zone lymphoma.
Select...
I've had treatment including an anti-CD20 agent but my cancer did not improve or got worse.
Select...
My cancer is a type of lymphoma confirmed by tissue analysis.

MAHOGANY Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
Secondary outcome measures
Complete Response Rate As Determined By BIRC And By Investigator Assessment
Duration Of Response As Determined By BIRC And By Investigator Assessment
HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L)
+8 more

Side effects data

From 2020 Phase 2 trial • 41 Patients • NCT03145064
22%
Neutrophil count decreased
17%
Hypokalaemia
12%
Platelet count decreased
10%
Blood creatinine increased
10%
Lymphocyte count decreased
10%
Cough
10%
Rash
10%
Hypertension
10%
White blood cell count decreased
10%
Constipation
10%
Diarrhoea
10%
Urinary tract infection
7%
Pneumonia
7%
Anaemia
7%
Leukopenia
7%
Upper respiratory tract infection
7%
Arthralgia
7%
Back pain
7%
Alanine aminotransferase increased
7%
Aspartate aminotransferase increased
7%
Weight decreased
5%
Skin infection
5%
Rash maculo-papular
5%
Lymph node pain
5%
Malaise
5%
Oedema peripheral
5%
Nasopharyngitis
5%
Influenza like illness
5%
Tinnitus
5%
Death
5%
Blood alkaline phosphatase increased
5%
Blood bilirubin increased
5%
Decreased appetite
5%
Hyperglycaemia
5%
Hypertriglyceridaemia
5%
Hyperuricaemia
5%
Hypoalbuminaemia
2%
Cataract
2%
Intestinal obstruction
2%
Gait inability
2%
Metabolic acidosis
2%
Sudden hearing loss
2%
Liver injury
2%
Abdominal pain
2%
Abdominal infection
2%
Herpes zoster
2%
Otitis media chronic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zanubrutinib

MAHOGANY 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
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
Zanubrutinib
2017
Completed Phase 2
~1270

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
174 Previous Clinical Trials
27,973 Total Patients Enrolled
Xia Zhao, MDStudy DirectorBeiGene
1 Previous Clinical Trials
123 Total Patients Enrolled
Chenmu Du, MDStudy DirectorBeiGene

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05100862 — Phase 3
Follicular Lymphoma Research Study Groups: Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab, Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab, Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab, Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
Follicular Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT05100862 — Phase 3
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05100862 — Phase 3

Frequently Asked Questions

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

When was Zanubrutinib cleared by the FDA?

"Zanubrutinib's safety is estimated to be a 3. This is because it is a Phase 3 trial, meaning that Zanubrutinib's efficacy has been supported by some data and its safety has been supported by multiple rounds of data."

Answered by AI

Zanubrutinib is most often recommended for what treatments?

"Zanubrutinib is a common treatment for diffuse large b-cell lymphoma (dlbcl). Additionally, this medication can be used to treat other b-cell lymphomas, as well as patients that have undergone two or more prior systemic chemotherapy treatments."

Answered by AI

Are there still opportunities to participate in this research?

"The trial is currently looking for participants, with the postings on clinicaltrials.gov indicating that the study is still open. The original posting was on March 10th, 2022, with the most recent update on October 5th, 2022."

Answered by AI
~500 spots leftby Jul 2028