Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance With Zanubrutinib for Newly-Diagnosed MCL
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|ClinicalTrials.gov Identifier: NCT04624958|
Recruitment Status : Not yet recruiting
First Posted : November 12, 2020
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma Newly-diagnosed Mantle Cell Lymphoma||Drug: Zanubrutinib and Rituximab Drug: R-DHAOx Drug: Zanubrutinib Maintenance||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: zanubrutinib, rituximab, consolidation chemotherapy and zanubrutinb maintenance
Part 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.
Drug: Zanubrutinib and Rituximab
Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.
Other Name: PART A
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.
Other Name: PART B
Drug: Zanubrutinib Maintenance
Zanubrutinb 160mg PO BID.
- Complete remission rate after PART A [ Time Frame: 3 years ]Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
- Complete remission rate after study treatment [ Time Frame: 3 years ]Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
- Objective Response rate [ Time Frame: 3 years ]Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
- Progression Free Survival [ Time Frame: 5 years ]The time from the start of treatment to the progression of the tumor or death (due to any cause).
- Overall Survival [ Time Frame: 5 years ]The time from the start of treatment to time of death (due to any cause).
- Time to Response [ Time Frame: 3 years ]The time from the start of treatment to the first assessment of complete remission or partial remission.
- Duration of Response [ Time Frame: 5 years ]The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
- Percentage of Participants With Adverse Events [ Time Frame: 3 years ]Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04624958
|Contact: Qingqing Cai, MDemail@example.com|
|Guangdong General Hospital|
|Guangzhou, Guangdong, China, 510000|
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Contact: Qingqing Cai, MD|
|The First Affiliated Hospital of Guangdong Pharmaceutical University|
|Guangzhou, Guangdong, China, 510060|
|Principal Investigator:||Qingqing Cai, MD||Sun Yat-sen University|