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This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma

ConditionsLymphoma, Mantle-CellLymphoma, Non-Hodgkin
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenan Cancer Hospital

About this trial

This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation in clinical study; Fully understand and understand the study and sign the informed consent form (ICF);Willingness to follow and ability to complete all study steps

Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)

The elderly group ≥65 years old;The young group was ≥18 years old and < 65 years old.

ECOG Performance Status 0-3

Disqualifiers

The presence of other tumors could affect the study medication or interfere with the results;

Patients require treatment with strong or moderate CYP3A inhibitors;

Pregnant or lactating women;

Known to be allergic to the test drug ingredients;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zanubrutinib,Obinutuzumab

    Drug

    Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease； Obinutuzumab ：Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks，up to 20 doses. 1 cycle = 28 days. Maintenance: Zanubrutinib, 160mg PO BID

  • Zanubrutinib and R-BAC

    Drug

    Induction: Zanubrutinib and R-BAC 6 cycles Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment Maintenance: Zanubrutinib continued until progression

Treatment groups

41 Participants
are divided into 2 treatment groups
Group A: Elder Patients（≥65）Experimental treatment 1 intervention
Group B: Young Patients with High risk （≥18，<65）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response rate after induction

Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time frame
3 yeas

Secondary outcomes

1

Complete remission rate after Interim treatment

Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time frame
3 years
2

MRD negativity rate after induction

MRD negativity rate after induction treatment

Time frame
3 years
3

Progression free survival (PFS)

The time from start of treatment to progression or death from any cause

Time frame
5 years
4

Overall survival (OS)

The time from start of treatment to death from any cause

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: