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Mantle Cell LymphomaPhase 2NCT04624958

Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL

A Phase 2 study testing Zanubrutinib and Rituximab, R-DHAOx and Zanubrutinib Maintenance in people with Mantle Cell Lymphoma and Newly-diagnosed Mantle Cell Lymphoma, run by Sun Yat-sen University at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Zanubrutinib and Rituximab, R-DHAOx and Zanubrutinib Maintenance
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
3 sitesChina
Study dates
1 Dec 2020to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed CD20 positive mantle cell lymphoma;
  • Patients with MCL-related symptomatic and need immediate therapy; Include any of the following: (1) Blastoid variant (2) Pleomorphic variant (3) Ki-67 ≥30% (4) Bulky mass > 7 cm or ≥2 tumors, each ≥5 cm in diameter (5) Mutations in TP53, c-MYC or NOTCH genes (6) Size of spleen ≥20 cm (7) Lymphoma B symptoms (8) Mantle Cell International Prognostic Score (MIPI) > 3 (9) Lymphoma threatening organ function (10) Elevated lactate dehydrogenase (11) Peripheral blood white blood cell > 50×10^9/L (12) Pancytopenia due to bone marrow involvement (13) Pain due to lymphoma;
  • Patients received no prior anti-lymphoma treatment;
  • At least one evaluable lesion according to 2014 Lugano criteria;
  • Ann Arbor stage II-IV;
  • Eastern Cooperative Oncology Group (ECOG) of 0-2;
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  • Life expectancy > 3 months;
  • Able to participate in all required study procedures;
  • Proper functioning of the major organs: 1) The absolute value of neutrophils (>1.5×10^9/L); 2) platelet count (> 75×10^9/L); 3) Hemoglobin (> 80 g/L); 4) Serum creatinine <1.5 times Upper Limit Normal (ULN) ; 5) Serum total bilirubin < 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) < 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time);

Who cannot join

  • Involvement of central nervous system (CNS)
  • Patients with Hemophagocytic syndrome;
  • Patients with active bleeding, bleeding tendency or require anticoagulation treatment;
  • Patients require treatment with strong CYP3A inhibitors;
  • Uncontrolled active infection, with the exception of tumor-related B symptom fever;
  • History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;
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  • Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;
  • Diagnosed with or receiving treatment for malignancy other than lymphoma;
  • Pregnant or breastfeeding women;
  • Other researchers consider it unsuitable for patients to participate in this study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510000

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Zanubrutinib and Rituximab Followed by R-DHAOx (Rituximab, Dexamethasone, Cytarabine and Oxaliplatin) Regimen Then Maintenance with Zanubrutinib for Newly-Diagnosed Mantle Cell Lymphoma (MCL): a Single Arm, Open Label, Multi-center Phase II Study

This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).

Being tested
Zanubrutinib and Rituximab, R-DHAOx, Zanubrutinib Maintenance
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zanubrutinib and RituximabDrug

    Also called PART A

    Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.

  • R-DHAOxDrug

    Also called PART B

    Rituximab 375mg/m2 iv.drip d1; Dexamethasone 20mg iv.drip d1-4; Cytarabine 2000mg/m2 (1000mg/m2 for patients aged over 65) iv.drip d2,3 Oxaliplatin 130mg/m2 iv.drip d1.

  • Zanubrutinib MaintenanceDrug

    Zanubrutinb 160mg PO BID.

Study groups in NCT04624958
Study groupRoleWhat they receive
zanubrutinib, rituximab, consolidation chemotherapy and zanubrutinb maintenanceExperimentalPart A (Zanubrutinib and Rituximab): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or until patients achieve CR. PART B (Consolidation chemotherapy of R-DHAOx): Patients receive R-DHAOx regimen every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Elderly patients (> 65 years old) and patients who achieved CR and minimal residual disease negative after PART B receive zanubrutinb maintenance therapy. Young patients (<65 years old) who achieved CR but minimal residual disease positive after PART B can receive autologous stem cell transplantation and then zanubrutinb maintenance therapy. Patients with PD, SD or PR after PART B quit the trial. ZANUBRUTINB MAINTENANCE: Patients receive zanubrutinib every day for up to one year.
Receives: Drug: Zanubrutinib and Rituximab; Drug: R-DHAOx; Drug: Zanubrutinib Maintenance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission rate after PART A

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

    Measured: 3 years

Secondary outcomes (7)

  1. Complete remission rate after study treatment

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

    Measured: 3 years

  2. Objective Response rate

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

    Measured: 3 years

  3. Progression Free Survival

    The time from the start of treatment to the progression of the tumor or death (due to any cause).

    Measured: 5 years

  4. Overall Survival

    The time from the start of treatment to time of death (due to any cause).

    Measured: 5 years

  5. Time to Response

    The time from the start of treatment to the first assessment of complete remission or partial remission.

    Measured: 3 years

  6. Duration of Response

    The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).

    Measured: 5 years

  7. Percentage of Participants With Adverse Events

    Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start1 Dec 2020
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624958
Sponsor's protocol ID
B2020-232-01
Status last verified
Oct 2024
First submitted
6 Nov 2020
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanubrutinib and Rituximab, R-DHAOx and Zanubrutinib Maintenance in people with Mantle Cell Lymphoma and Newly-diagnosed Mantle Cell Lymphoma, run by Sun Yat-sen University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate after PART A (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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