ZR2 Sequential Immunochemotherapy for Newly Treated MCL

NCT05992597 | Recruiting Phase 2

• 1 other identifier: ZR2 + RDHAP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with newly diagnosed MCL were treated with ZR2 regimen for 3 cycles, followed by 3 cycles of immunochemotherapy, and zebrutinib maintenance therapy for 2 years after the end of induction therapy, in order to improve the remission rate and prognosis of patients with induction therapy.

Conditions

Rituximab, Lenalidomide, Zebutinib ，Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  Time Frame: 21days after the end of treatment

Secondary Outcomes (3)

• PFS

  Time Frame: From date of first day of treatment until the date of first documented progression, assessed up to 24 months

• OS

  Time Frame: From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months

• AE and SAE

  Time Frame: From date of first day of treatment until 30 day after last treatment

Study Arms (1)

rituximab, lenalidomide, and zebutinib,RDHAP

EXPERIMENTAL

Drug: ZR2 RDHAP

Interventions

ZR2 RDHAP DRUG

ZR2:Rituximab 375mg/m2, D1, Lenalidomide 24mg qd D1-14, zebutinib 160mg bid RDHAP:Rituximab 375mg/m2 D0, dexamethasone 40mg D1-4, cytarabine 2g/m2 q12h D2, cisplatin 25mg/m2 D1-3.

rituximab, lenalidomide, and zebutinib,RDHAP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.
• \~75 years old (inclusive), male and female.
• Histopathologically confirmed mantle cell lymphoma, including positive immunohistochemical CyclinD1 (CyclinD1 or CCND1) and/or chromosomal t (11; 14) (q13; Q32) ectopic.
• No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer).
• there must be at least one evaluable or measurable lesion that meets Lugano2014 criteria (evaluable lesion: PET/CT examination showing increased uptake in lymph nodes or extratodal areas (higher than liver) and PET/CT and/or CT features consistent with lymphoma; Measurable lesions: nodular lesions \>15mm in length or extragendal lesions \>10mm in length with increased FDG uptake).
• Adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency (no blood transfusion, granulocytic colony stimulating factor or other relevant medical support within 14 days prior to the use of the study drug) :
• A) Blood routine: neutrophil absolute count (ANC) ≥1.5×109/L (1500/mm3), platelet ≥75×109/L, hemoglobin ≥100g/L (if bone marrow is involved, platelet ≥50×109/L, ANC ≥1.0×109/L, hemoglobin ≥80g/L).
• B) Liver function: serum bilirubin ≤2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (AST is allowed if liver is involved, ALT≤5 times the upper limit of normal value).
• C) Renal function: creatinine clearance ≥60 mL/min (estimated according to the Cockcroft-Gault formula).
• D) Coagulation function: INR≤1.5 times the upper limit of normal value; PT and APTT≤1.5 times the upper limit of normal value.
• Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
• Male subjects used effective contraception from signing informed consent until 6 months after the last chemotherapy.
• Life expectancy \> 3 months.

You may not qualify if:

• The diagnosis was leukemic mantle cell lymphoma.
• Central nervous system involvement secondary to lymphoma.
• People with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired Immunodeficiency syndrome. Screening stage of hepatitis b surface antigen or hepatitis c virus antibody positive patients, must further by hepatitis b virus DNA (no more than 1000 iu/ml) and HCV RNA detection (shall not exceed the method detection limit), in the activity of the ruled out the need for treatment after hepatitis b or hepatitis c infection, before the experiment. Patients with hepatitis B virus carriers, stabilized hepatitis B after drug treatment and cured hepatitis C can be included.
• Major surgery was performed within 28 days prior to study initiation.
• Any active infections, including but not limited to bacterial, fungal or viral infections, that require systemic antiinfective therapy within 14 days prior to initiation of treatment.
• combined with severe or uncontrolled disease, including but not limited to symptomatic of congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or A history of severe hemorrhagic diseases, such as hemophilia a., hemophilia B, von willebrand disease or blood transfusion or other medical intervention history of spontaneous bleeding.
• History of stroke or intracranial hemorrhage within 6 months prior to first administration of the study drug.
• A history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.
• Patients who must take antiplatelet drugs and anticoagulant drugs at the same time due to underlying diseases and have no alternative treatment plan.
• Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required. Patients were excluded if they had taken a CYP3A potent or moderate-acting inhibitor or inducer within 7 days prior to the first administration of the study drug (or had taken these drugs for less than 5 half-lives).
• Patients deemed unsuitable for the study by other investigators.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)