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Diffuse Large B-Cell LymphomaPhase 2NCT05875428

Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Diffuse Large B-Cell Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A multicenter, single-arm, phase 2 study of mitoxantrone hydrochloride liposome injection in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Mitoxantrone Hydrochloride Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteChina
Study dates
10 Jul 2023to 30 Sep 2025
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to understand and comply with the study, and voluntarily sign informed consent.
  • Age ≥ 18 years old.
  • Previously treated, pathologically confirmed primary DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
  • Patients are not suitable for high-dose chemotherapy combined with autologous stem cell transplantation as rescue therapy.
  • Relapsed or refractory disease after at least (≥) 2 lines of systemic therapy (including at least a regimen of anti-CD20 immunotherapy combined with cytotoxic drugs was included), there is no suitable and conventional therapy.
  • Patients have at least one measurable lesion in accordance with the Lugano evaluation criteria (version 2014):(if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progression after radiotherapy).
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  • Confirmation of no objective response from the most recent therapy (at least 2 cycles of administration, and efficacy assessed as stable disease or progressive disease) or disease progression after therapy.
  • Patients must agree to provide the most recent tumor tissue section or have a biopsy of tumor tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Estimated life expectancy ≥ 3 months.
  • Patients should meet the following requirements and have not received infusion of cell growth factor, blood transfusion, or blood product within 14 days of the hematology test:
  • Absolute value of neutrophils ≥ 1.5 × 10^9/L; Hemoglobin≥80g/L; Platelet ≥ 75 × 10^9/L;
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST and ALT ≤ 5 × ULN for patients with liver metastasis. Total bilirubin ≤1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome).
  • Creatinine clearance ≥ 50 mL/min or serum creatinine ≤ 1.5 × ULN。
  • Coagulation function: prothrombin time or activated partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5.
  • Female patients of childbearing age must have a negative pregnancy test at the time of enrollment within one week, and must agree to use an effective method of contraception from the study initiation until at least 4 months after the last treatment; Male patients must agree to use an effective method of contraception from the study initiation until at least 6 months after the last treatment. During the study, oocyte donation of female patients and sperm donation of male patients are not allowed.
  • COVID-19 patients without related symptoms after two weeks can be enrolled.

Who cannot join

  • Primary central nervous system lymphoma, unclassified B-cell lymphoma between DLBCL and classical Hodgkin's lymphoma, primary effusion lymphoma, plasmablastic lymphoma or DLBCL transformed from previously diagnosed non-indolent lymphoma.
  • Patients with active central nervous system and meninx involvement.
  • Previously treated with mitoxantrone or mitoxantrone liposome.
  • Previously treated with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) > 400 mg/m^2.
  • Previously treated with chimeric antigen receptor T-cell.
  • History of autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 6 months prior to screening.
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  • Patients With interstitial lung disease that requires treatment.
  • History of other malignant tumor within 5 years, except for DLBCL in this trial or resected locally cancer that has been cured (e.g.basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
  • Participating in any other intervention clinical trials within 4 weeks prior to the first dose except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
  • Any steroid hormone treatment within 4 weeks prior to the first dose, chemotherapy and targeted therapy within 28 days, radiotherapy within 14 days, antibody therapy within 28 days, Chinese herbal treatment within 14 days.
  • Adverse events from the previous treatment have not resolved to ≤ Grade 1 (except for alopecia, hyperpigmentation).
  • HIV infection, active hepatitis B (positive for HBsAg, or positive for HBcAb with positive for HBV-DNA PCR), active hepatitis C(positive for anti-HCV with positive for HCV-RNA PCR), or active syphilis infection; for patients with HBV infection, consider enrolment if the disease is under control.
  • Patients with active pulmonary tuberculosis.
  • Any active infections requiring systemic or venous anti-infective treatment.
  • Patients with major surgery within 4 weeks prior to the first dose, and not recovered from any previous creative operation.
  • Any of the following conditions occurs in cardiac function:
  • Electrocardiographic examination: QTc >480 msec;
  • Clinically significant arrhythmias, including but not limited to complete left bundle branch block or Second-degree atrioventricular block disease, PR> 250 msec;
  • Any risk that increase prolonged QTc or arrhythmia events, for example uncorrectable hypokalemia, hereditary long QT syndrome, and patients treated with medications that prolong QT intervals but discontinuation for less than 15 days;
  • History of congestive heart failure, New York Heart Association (NYHA)≥grade 2;
  • The cardiac ejection fraction is less than 50% or lower than the lower limit of the laboratory test value range of the research center;
  • History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months prior to the first dose.
  • History of allergy and contraindications to the same class and excipients of the experimental drug.
  • Pregnant or breastfeeding women;
  • Not suitable for this study as determined by the investigator due to other reasons (e.g.uncontrolled hypertension, uncontrolled diabetes, active bleeding, etc).

Trial locations and contacts

1 site in 1 country.

Clinical Trials Information Group officer contact

+86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Zengjun Li, +8613642138692, zengjunli@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 2, Single-arm, Multicenter Trial to Evaluate the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A multicenter, single-arm, phase 2 study of mitoxantrone hydrochloride liposome injection in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Read the detailed description

This is a phase 2, single-arm, multicenter trial to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in patients with R/R DLBCL. The eligible patients will receive mitoxantrone hydrochloride liposome injection (20 mg/m^2) once every 4 weeks for a maximum of 8 cycles. Patients will receive treatment until the completion of 8 cycles of treatment, disease progression, intolerable toxicity, death, loss to follow-up, withdrawal (patient's decision or investigator's decision), whichever comes first. All patients will have post-treatment follow-up for disease status until disease progression/recurrence, initiation of new antitumor therapy, or being lost to follow-up.

Being tested
Mitoxantrone Hydrochloride Liposome Injection
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Mitoxantrone Hydrochloride Liposome InjectionDrug

    Be given intravenously at 20 mg/m^2 on days 1 of each treatment cycle.

Study groups in NCT05875428
Study groupRoleWhat they receive
Mitoxantrone Hydrochloride Liposome InjectionExperimentalThe eligible patients will receive mitoxantrone hydrochloride liposome injection (20 mg/m^2) once every 4 weeks for a maximum of 8 cycles.
Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection

What is being measured

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

  1. ORR assessed by the IRC

    ORR (objective response rate) assessed by the Independent Review Committee (IRC)

    Measured: Throughout the study period, up to approximately 2 years

Secondary outcomes (7)

  1. ORR assessed by investigators

    ORR (objective response rate) assessed by investigators

    Measured: Throughout the study period, up to approximately 2 years

  2. DCR

    Disease control rate

    Measured: Throughout the study period, up to approximately 2 years

  3. DOR

    Duration of response

    Measured: Throughout the study period, up to approximately 2 years

  4. PFS

    Progression-free survival

    Measured: Throughout the study period, up to approximately 2 years

  5. OS

    Overall survival

    Measured: Throughout the study period, up to approximately 2 years

  6. TEAE

    Treatment emergent adverse event

    Measured: Throughout the study period, up to approximately 2 years

  7. Blood concentrations of total and free mitoxantrone

    Measured: Throughout the study period, up to approximately 2 years

Timeline

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

  1. First posted25 May 2023
  2. Study start10 Jul 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Sep 2025 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05875428
Sponsor's protocol ID
HE071-033
Status last verified
Apr 2023
First submitted
16 May 2023
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Diffuse Large B-Cell Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 17 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Clinical Trials Information Group officer (+86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR assessed by the IRC (time frame: Throughout the study period, up to approximately 2 years). 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 NCT05875428.

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 8 Feb 2024.

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