Mantle Cell Lymphoma, Newly-diagnosed Mantle Cell Lymphoma
Conditions
Brief 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).
Interventions
Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.
DRUGR-DHAOx
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.
Zanubrutinb 160mg PO BID.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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; * 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);
Exclusion criteria
* 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate after PART A | 3 years | Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response rate | 3 years | Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Progression Free Survival | 5 years | The time from the start of treatment to the progression of the tumor or death (due to any cause). |
| Overall Survival | 5 years | The time from the start of treatment to time of death (due to any cause). |
| Complete remission rate after study treatment | 3 years | Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Duration of Response | 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 | 3 years | Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0 |
| Time to Response | 3 years | The time from the start of treatment to the first assessment of complete remission or partial remission. |
Countries
China
Outcome results
None listed