NCT06136351

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
18mo left

Started Nov 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Nov 2023Nov 2027

First Submitted

Initial submission to the registry

September 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

September 25, 2023

Last Update Submit

November 24, 2023

Conditions

Lymphoma, Mantle-Cell

Outcome Measures

Primary Outcomes (1)

  • 2-year Progression-Free Survival

    Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.

    2 years

Secondary Outcomes (4)

  • ORR

    End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]

  • CRR

    End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]

  • OS

    Baseline up to data cut-off (up to approximately 2 years)

  • Adverse Events

    Baseline up to data cut-off (up to approximately 2 years)

Study Arms (1)

ZBR

EXPERIMENTAL
Drug: ZanubrutinibDrug: RituximabDrug: Bendamustin

Interventions

ZanubrutinibDRUG

160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up

ZBR
RituximabDRUG

375 mg/m\^2 ivgtt, D0 of each 28-day cycle

ZBR
BendamustinDRUG

90mg/m\^2 ivgtt, D0 of each 28-day cycle

ZBR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)
  • FISH with del(17p)/TP53 mutation or ≥65 years; or\<65 years but chemotherapy intolerance;
  • Life expectancy of \> 3 months (in the opinion of the investigator);
  • Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m\^2);
  • International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
  • Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

You may not qualify if:

  • Pregnant or lactating women;
  • Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
  • With acquired or congenital immunodeficiency;
  • With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
  • Known to be allergic to the test drug ingredients;
  • Diagnosed with or being treated for malignancy other than lymphoma;
  • With severe infection;
  • Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
  • Deemed unsuitable for the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

zanubrutinibRituximabBendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2023

First Posted

November 18, 2023

Study Start

November 15, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)