AzTrials
AzTrials

Mantle Cell LymphomaPhase 1NCT03836768

BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma

A Phase 1 study testing DTRMWXHS-12 in people with Mantle Cell Lymphoma, run by Zhejiang DTRM Biopharma at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
DTRMWXHS-12
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
11 Jan 2019to 17 Nov 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 Years old (include 18 and 75), gender is not limited.
  • 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.
  • 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.
  • The laboratory parameters are as follows:
  • 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.
  • 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).
Show all 15Show fewer
  • 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))
  • 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.
  • ECOG performance status score 0-2.
  • Life expectancy > 3 months.
  • There must be documentations on relapsed or refractory lymphoma or disease progression after systemic therapy and at least one but less than five therapies for mantle cell lymphoma were administrated previously (1 ≤ number of previous therapies < 5).
  • No response with the last therapy (SD or PD during the treatment), or PD after the therapy.
  • Patients with disease recurrence at least 3 months after autologous hematopoietic stem cell transplantation can be enrolled into the study, if there isn't any relevant active infection.
  • Females of child-bearing potential must agree to use highly effective contraception methods during the study and at least 180 days after the last dose of the investigational drug. Highly effective contraception methods include abstinence, hysterectomy, bilateral ovariectomy without menstruation for six consecutive months, intrauterine contraception systems, hormonal contraception such as injectable contraceptives and oral contraceptives. Males must be sterilized via either vasectomy, or use barrier methods, while their female partners should take the effective contraception methods mentioned above.
  • Patients are voluntary to sign the informed consent form and can understand and comply with all study requirements.

Who cannot join

  • Patients suffering from or previously suffering from CNS lymphoma.
  • 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.
  • Patients received major surgery in the past 4 weeks before screening (determined by the investigator according to the patient's condition).
  • Patients with active bleeding or combination with anticoagulant therapy within 3-6 months.
  • Patients had undergone chemotherapy before and in whom the toxicity has not resolved (the toxicity has not resolved to ≤ grade 1 as per National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, except for hair loss, absolute neutrophil count (ANC) and platelets). For neutrophils and platelets, please refer to the criterion 4 [Neutrophils] and [Platelets] in the inclusion criteria.
  • Patients with a history of other active malignant diseases within 2 years prior to enrollment into the study, excluding the following: (1) adequately treated cervical carcinoma in situ; (2) local skin basal cell carcinoma or squamous cell carcinoma; (3) malignant diseases that has been controlled and completely locally treated (by surgery or other means)
Show all 17Show fewer
  • Patients suffering from active cardiovascular diseases with clinical significance, such as uncontrolled arrhythmia, congestive heart failure, Grade 3 or 4 heart disease according to New York Heart Association (NYHA) Functional Classification, or those with history of myocardial infarction within 6 months before screening.
  • QTcF>450 msecs or other significant ECG abnormalities, including second-degree atrioventricular block type Ⅱ, third-degree atrioventricular block.
  • Patients who can't swallow capsules or with diseases significantly affect the gastrointestinal function, such as malabsorption syndrome, gastric or intestinal resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction.
  • Uncontrolled systemic infections or infections requiring to be treated with intravenous antibacterial agents.
  • Patients who previously received allogeneic stem cell transplantation.
  • Patients known to have been infected with human immunodeficiency virus (HIV) or active hepatitis B or hepatitis C virus (polymerase chain reaction [PCR] or reverse transcription- polymerase chain reaction (RT-PCR) shows positive results).
  • Hepatitis B test includes HBsAg, HBcAb and HBsAb. If the patient is HBsAg-negative but HBcAb-positive (regardless of HBsAb), the PCR technology will be used to detect hepatitis B virus (HBV) DNA, and the acceptable upper limit of normal in the table below is 1000 IU/mL. Considering different PCR kits may be used by different sites, the acceptable upper limit of normal for HBV DNA should be the normal value in the site. Hepatitis C test includes hepatitis C virus (HCV) antibody test, and if the HCV antibody is positive, the RT-PCR technology will be used to detect HCV RNA.
  • Pregnant or lactating women.
  • Any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect subject safety or lead to study risks.
  • Patients with poor compliance.
  • Patients who receive treatment with a potent CYP3A (cytochrome P450, family 3, subfamily A) inhibitor or a potent CYP3A inducer within 7 days prior to enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital

    Beijing

Other trials in China

About this study

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

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.

Being tested
DTRMWXHS-12
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DTRMWXHS-12Drug

    DTRMWXHS-12 capsules: 150 mg, 300 mg

Study groups in NCT03836768
Study groupRoleWhat they receive
Experimental TreatmentExperimentalDTRMWXHS-12, oral capsule, daily, 28 days as a cycle
Receives: Drug: DTRMWXHS-12

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Incidence and severity of (serious) adverse events n each patient according to the NCI-CTCAE4.03 grading

    To monitor AEs and SAEs in each patient according to the NCI-CTCAE4.03 grading criteria by evaluating changes in physical examination, laboratory tests, and 12-lead ECG during the whole study

    Measured: Starting from date of first dose up to 35 days after last dose

Secondary outcomes (1)

  1. concentration of drug in plasma

    concentration of drug in plasma

    Measured: From date of first dose to day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2019
  2. Study start11 Jan 2019
  3. Primary completion17 Nov 2021
  4. Study completion17 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03836768
Sponsor's protocol ID
DTRM_DTRMWXHS-12_004
Status last verified
Feb 2023
First submitted
30 Jan 2019
Last updated
15 Feb 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DTRMWXHS-12 in people with Mantle Cell Lymphoma, run by Zhejiang DTRM Biopharma at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Incidence and severity of (serious) adverse events n each patient according to the NCI-CTCAE4.03 grading (time frame: Starting from date of first dose up to 35 days after last dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03836768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in