Trials Sponsors Conditions Drugs Pricing

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 RDHAPDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Zhejiang Cancer Hospital
Otherlead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Haiyan Yang, PhDCONTACT0086-571-88122192 yanghy@zjcc.org.cn

Xi Chen, MDCONTACT0086-571-88122192 zjuchenxi@126.com

Xi Chen, MDSUB INVESTIGATOR

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

Actual (reported)

Primary Completion

August 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

ZR2 Sequential Immunochemotherapy for Newly Treated MCL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

rituximab, lenalidomide, and zebutinib,RDHAP

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

rituximab, lenalidomide, and zebutinib,RDHAP

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations