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BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma

A Phase Ib Study of BTK Inhibitor DTRMWXHS-12 in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

NCT03836768•Zhejiang DTRM Biopharma

Summary

The Primary Objective is to evaluate the safety and tolerability of the DTRMWXHS-12 capsule in patients with relapsed/refractory MCL and recommend the dose and dosing method (RP2D) used in phase II study. The Secondary Objective is to evaluate the pharmacokinetics (PK) of multiple dose oral administration of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL. The Exploratory Objective is to preliminarily evaluate the efficacy of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-75 Years old (include 18 and 75), gender is not limited.
•2. Measurable lesions by computed tomography (CT)/magnetic resonance imaging (MRI). A measurable lesion is defined as follows: at least the longest diameter of one lymph node \>1.5cm and clearly measurable in two vertical directions, or at least the longest diameter of one extranodal lesion \>1cm (e.g., liver nodule); If only spleen or gastrointestinal mucosa is involved, corresponding examinations and evaluations will be conducted in the investigator's opinion.
•3. The diagnosis report must contain morphology and evidence of positive cyclin D1 by immunohistochemistry or evidence of t (11; 14). The above results are tested by immunohistochemistry, cytogenetics or Fluorescent in situ hybridization (FISH). After enrollment, tumor tissue (FFPE) blocks or sections must be sent to the central laboratory for confirmation of MCL.
•4. The laboratory parameters are as follows:
•1. Hematology: Neutrophils ≥ 1.0×10\^9/L without growth factor or blood transfusion, platelets ≥ 75×10\^9L (≥50×10\^9/L if bone marrow is involved), and hemoglobins \> 9g/dL within 7 days before enrollment into the study.
•2. Liver: Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5×ULN; total bilirubin ≤ 2×ULN (\< 3×ULN when diagnosed as Gilbert's syndrome).
•3. Kidney: Creatinine clearance≥30 ml/min (Evaluated by estimated glomerular filtration rate \[eGFR\] according to the Cockcroft-Gault Equation or the calculation equation of each site); Cockcroft-Gault equation= Female: (140-age)×weight(kg)×0.85/(72×serum creatinine (mg/dL)) Male: (140-age)×body weight(kg)/(72×serum creatinine(mg/dL))
•4. international normalized ratio(INR) ≤ 1.5×ULN and activated partial thromboplastin time (APTT) ≤ 1.5×ULN, and for patients with acquired hemophilia or those treated with clotting factor inhibitors or vitamin K antagonists, the enrollment will be determined after discussion with the investigator.
•5. ECOG performance status score 0-2.
•6. Life expectancy \> 3 months.
+17 more criteria

Exclusion Criteria

•1. Patients suffering from or previously suffering from CNS lymphoma.
•2. Patients received other BTK inhibitors prior to enrollment. Patients who received steroid anti-tumor therapy (a dose equivalent to\>20mg/day of prednisone) within 7 days, or received chemotherapy, targeted therapy, or radiotherapy within 4 weeks, or received anti-tumor Chinese medicinal herbs or antibody therapy within 4 weeks, prior to first administration of DTRMWXHS-12 capsule.
•3. Patients received major surgery in the past 4 weeks before screening (determined by the investigator according to the patient's condition).
•4. Patients with active bleeding or combination with anticoagulant therapy within 3-6 months.

Locations (1)

Peking University Cancer Hospital

Beijing, China

Key Dates

Start Date

January 11, 2019

Primary Completion Date

November 17, 2021

Completion Date

November 17, 2021

Last Updated

February 15, 2023

Enrollment

ACTUAL participants

Conditions

Mantle Cell Lymphoma

Interventions

DTRMWXHS-12

DRUG

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

View study

RECRUITINGPHASE2

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

A Long-term Extension Study of PCI-32765 (Ibrutinib)