Untreated Mantle Cell Lymphoma
Conditions
Keywords
Mantle Cell Lymphoma; Zanubrutinib; Rituximab; ASCT
Brief summary
The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.
Detailed description
The study will start with an initial 28-days of induction immunotherapy with ZR and 4 cycles of consolidation immunotherapy with ZR，following imaging examinations to evaluate response rates. Patients who are evaluated as SD and PD will be withdrawn from the trial,while those who achieve PR and CR will be further stratified according to their age and physical status. The older or frail patients who are ineligible for ASCT will take zanubrutinib orally until intolerable toxicity or disease progression. Patients who are young and fit for transplantation will receive ASCT consolidation. After ASCT, patients with CR will end therapy and enter the follow-up stage, while patients with PR will continue to take zanubrutinib orally until intolerable toxicity or disease progression.
Interventions
zanubrutinib 160mg PO BID d1-28; rituximab 375mg/m2 IVGTT d1,8,15,22. Other name: Part A
DRUGBEAM pretreatment
semustine 250mg/m2 PO d1; etoposide 200mg/m2 IV d2-5; cytarabine 400mg/m2 IV d2-5; melphalan 140mg/m2 IV d6.
zanubrutinib 160mg PO BID.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases; 2. Initial untreated patients; 3. Age ≥ 18 years; 4. ECOG score 0-2; 5. Women must not be pregnant or breastfeeding and agree to avoid pregnancy prior to study entry, for the duration of study participation, and for 12 months thereafter. Male patients must agree that their spouses will not become pregnant during the study period and for 12 months thereafter; 6. Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination); 7. Written informed consent obtained from the subject.
Exclusion criteria
1. Indolent Mantle Cell Lymphoma; 2. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal) 3. Uncontrolled active infection, with the exception of tumor-related B symptom fever; 4. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2); 5. Co-existence of other tumors; 6. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate(CRR) in patients received ASCT | 1 month after ASCT | The rate of patients who achieved complete response after ASCT. |
| Overall Response Rate(ORR) in all patients | At the end of cycle 3 and cycle 5(each cycle is 28 days) | The rate of patients who achieved complete response and partial response after ZR combined immunotherapy |
| Complete Response Rate(CRR) in all patients | At the end of cycle 3 and cycle 5(each cycle is 28 days) | The rate of patients who achieved complete response after ZR combined immunotherapy. |
| Overall Response Rate(ORR) in patients received ASCT | 1 month after ASCT | The rate of patients who achieved complete response and partial response after ASCT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | up to 24 months after the last patient's enrollment. | OS will be assessed from the first ZR given to date of death or end of follow-up. |
| Progression Free Survival (PFS) | up to 24 months after the last patient's enrollment. | PFS will be assessed from the first ZR given to date of progression, relapse, death or end of follow-up. |
| Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events | initiation of study drug until 30 days after last dose. | The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events. |
| Minimal Residual Disease (MRD) | At the end of cycle 5 ZR (each cycle is 28 days) and 1 month after ASCT. | — |
Countries
China
Contacts
Primary ContactZhengming Jin
Backup ContactChangju Qu
Outcome results
None listed