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Relapsed or Refractory Peripheral T-cell and NK/T-cell LymphomaPhase 2NCT03776279

A Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Relapsed or Refractory Peripheral T-cell and NK/T-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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single-arm, open, multi-center, phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection in Relapsed or refractory peripheral t-cell and NK/T-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
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
106 participants
Where
1 siteChina
Study dates
2 Apr 2018to 30 Dec 2020
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

  • Subjects must satisfy all the following conditions before enrollment:
  • Those who have fully understood the study and have signed the ICF.
  • Male or female, aged 18 or above (including 18).
  • Those with PTCL and NK/T-cell lymphoma confirmed by histopathological and/or cytological examination, with the subtypes as follows:
  • Peripheral T-cell lymphoma, unspecified (PTCL, NOS)
  • Angioimmunoblastic T-cell lymphoma (AITL)
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  • ALK+systematic anaplastic large T-cell lymphoma (ALCL, ALK+)
  • ALK-systematic anaplastic large T-cell lymphoma (ALCL，ALK-)
  • Extranobal NK/T cell lymphoma (nasal type) (NKTCL)
  • Enteropathy-associated T-cell lymphoma (EATCL, Type I (traditional type), Type II)
  • Hepatosplenic γδ T-cell lymphoma (HSTCL, γδT) hOther non-Hodgkin's lymphomas from invasive T-cells (other than highly invasive cells) approved by the sponsor, who may be enrolled in the opinion of the investigator.
  • Those receivd at least first-line standard treatment (including chemotherapy and autologous hematopoietic stem cell transplantation) If anthracycline or anthracycline-containing chemotherapy has been used in the past, the efficacy is assessed as response; if they were NK/T-cell lymphoma patients, they need to be treated with asparaginase (or pepsinase, L-asparaginase) treatment.
  • Subjects who must provide the written pathological/histological diagnosis report during the screening period, and agree to provide the tumor tissue sections or fresh tumor tissues to the Center Laboratory for testing.
  • Those with ECOG performance status score of 0 or 1.
  • The estimated survival time was at least 12 weeks.
  • Those at least with one measurable lesion in accordance with the revised standard for evaluation of efficacy in malignant lymphoma (Version 2007): the long axis of the lesion shall be>1.5 cm or 1.0~1.5 cm and the short axis of the lesion shall be>1.0 cm.
  • Subjects who shall meet the following requirements for laboratory examination when screening and who have not received cell growth factor (long-acting granulocyte-colony stimulating factor [G-CSF] and [PEG-CSF] shall have the interval of 14 days) and platelet or granulocyte infusion within 7 days before hematological evaluation for screening:
  • Absolute value of neutrophils ≥ 1.5 × 109/ L in subjects without involvement of bone marrow; absolute value of neutrophil ≥ 1.0 × 109/ L in subjects with involvement of bone marrow;
  • Hemoglobin ≥ 90 g/L (without red cell infusion within 14 days), hemoglobin ≥ 75 g/ L in subjects with involvement of bone marrow;
  • Platelet ≥ 75 × 109/ L in subjects without involvement of bone marrow; platelet ≥ 50 × 109/ L in subjects with involvement of bone marrow;
  • Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin ≤ 3 × ULN if bilirubin level increase is caused by lymphoma invading the liver);
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; if AST or ALT increase is caused by lymphoma invading the liver, both AST and ALT shall be ≤ 5 × ULN);
  • Creatinine < 1.5 × ULN.
  • Female subjects:
  • Without fertility (i.e., unable to get pregnant under physiological condition), including postmenopausal (complete cessation of menstruation for ≥ 1 year) or documented irreversible sterilization including hysterectomy, bilateral ovariectomy or bilateral salpingectomy (rather than tubal ligation);
  • With fertility potential, who shall be negative when serum pregnancy test screening (within 7 days of the first administration of study drug) and agree to take effective contraception measures during the study period and within 90 days after the last administration. Subjects shall always practice contraception strictly in accordance with the labels of contraceptive drugs/devices and the instructions of the investigator. Effective contraception measures shall be defined as follows:
  • i)Sex partner vasectomized is the sole sex partner of the female subject; ii)Use of IUDs with a failure rate of less than 1% per year iii)Double contraception, e.g. spermatocide plus male condom, female condom, diaphragm, cervical cap or intrauterine device.
  • Male subjects: who shall have received the vasectomy, or agree to take effective contraception measures during the study period and within 30 days after the last administration.
  • Subjects who are able to comply with the study procedures, restrictions and requirements as judged by the investigator.

Who cannot join

  • Subjects consistent with any one of the following conditions:
  • Subjects in lymphoma leukemia (malignant cell proportion of > 20% in bone marrow examination);
  • Subjects are consistent with one of the following conditions in the previous anti-tumor treatment history:
  • Those receiving Mitoxantrone or Liposome-entrapped Mitoxantrone previously;
  • Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of > 360 mg/m2 (when converted to 1 mg Adriamycin, other anthracyclines shall be equivalent to 2 mg Epirubicin or 2 mg Pirarubicin or 2 mg Daunorubicin or 0.5 mg Idarubicin);
  • Those receiving anti-tumor treatment (including chemotherapy, radiotherapy, hormone therapy or administration of TCM with anti-tumor activity) within 4 weeks prior to the first use of the study drug);
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  • Those receiving autologous hematopoietic stem cell transplantation within 6 months;
  • Those receiving allogeneic hematopoietic stem cell transplantation previously.
  • Those receiving major surgery (the definition of major surgery shall refer to the Level 3 or 4 surgery stipulated in the Management Practices of Clinical Application of Medical Technology) within 4 weeks prior to enrollment or those who have not completely recovered from any previous invasive operation.
  • Those who have not recovered from toxic response in the previous anti-tumor treatment (>Grade 1 in NCI-CTCAE [Version 4.03], with the exception of hair loss and pigmentation.
  • Those with other malignant tumors previously or currently (except the non-melanoma skin basal cell carcinoma under effective control, breast/cervical carcinoma in situ, and other malignant tumors not treated but under effective control in the past five years).
  • Subjects with known or existing primary or metastatic central nervous system lymphoma, or with existing other cerebral/meningeal diseases.
  • Subjects with uncontrolled hypertension (refers to systolic pressure of 180 mmHg and/or diastolic pressure of 100 mmHg after treatment).
  • Subjects with active hemorrhagic disease.
  • Subjects with active infection, including hepatitis B (positive hepatitis B virus surface antigen and hepatitis B virus DNA of more than 1,000 copies/mL) and hepatitis C (positive hepatitis C virus RNA).
  • Human immunodeficiency virus (HIV) infection (HIV positive).
  • Subjects with history of hepatic fibrosis or cirrhosis or with clinical signs and symptoms suggestive of liver fibrosis or cirrhosis.
  • Subjects with the cardiac function and disease:
  • Male: QTc>450 ms, female: QTc>470 ms when ECG examination in the Research Center during the screening period;
  • Clinically significant arrhythmias, including but not limited to complete left bundle branch block, Degree II atrioventricular block and PR interval > 250 ms;
  • Any risk factor that might increase the QTc interval, e.g. hypokalaemia, inherited long-QT syndrome, with current administration of the drug for prolonging the QT interval or discontinuance for less than 15 days;
  • Congestive heart failure of ≥Grade 2 in the New York Heart Association;
  • Cardiac ejection fraction less than 50% or less than the lower limit of laboratory examination vale range of Research Center;
  • Within six months prior to recruitment occurred myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinical history of severe pericardial disease, or electrocardiographic evidence of acute ischemia or abnormal active conduction system.
  • Subjects with known history of immediate or delayed hypersensitivity to the similar drug and excipient of the study drug.
  • Pregnant or lactating women.
  • According to the judgement of the investigators ,Those with any severe or uncontrolled systematic disease, systematic complication, other severe complicated diseases (e.g. hemophagocytic syndrome) or special tumor condition that might make the subjects unsuitable for entry into the study or might affect the compliance to the protocol or might cause significant interference with the correct evaluation of safety, toxicity and efficacy of the study drug.

Trial locations and contacts

1 site in 1 country.

Huiqiang Huang, Doctor contact

020-87343350

huanghq@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Huiqiang Huang, Doctor, 020-87343350

    Recruiting

Other trials in China

About this study

Official title: Single-arm, Open and Multi-center Phase II Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma

This is a single-arm, open, multi-center, phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection in Relapsed or refractory peripheral t-cell and NK/T-cell lymphoma.

Read the detailed description

The dosage regimen of Liposome-entrapped Mitoxantrone is multi-cycle 20mg/m2 intravenous infusion. Every 4 weeks is a treatment cycle, with administration on the first day of each cycle. End-of-treatment visit will be made to the subjects within 4 weeks after the end of the last administration. Progression-free survival (PFS) follow-up will be conducted to the subjects in stable or improved condition after treatment and the subjects with early termination of treatment due to intolerance in Week 8 after the last administration of study drug, and thereafter once every 8 weeks until PD, death, withdrawal of informed consent form (ICF), starting another new treatment or end of the entire study (whichever occurs first). Meanwhile, overall survival (OS) follow-up will also be conducted to the subjects with PD and starting another new treatment once every 8 weeks until death, withdrawal of ICF or end of the entire study (whichever occurs first).

Being tested
Mitoxantrone Hydrochloride Liposome Injection
Medical subject headings
Recurrence, Lymphoma, Extranodal NK-T-Cell

What participants receive

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

  • Mitoxantrone Hydrochloride Liposome InjectionDrug

    Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 60min in 250 ml 5％ glucose injection on the first day during a treatment phase of 4 weeks.

Study groups in NCT03776279
Study groupRoleWhat they receive
Mitoxantrone Hydrochloride Liposome InjectionExperimental4 weeks is a treatment cycle, and the first day of each cycle is administered.
Receives: Drug: Mitoxantrone Hydrochloride Liposome Injection

What is being measured

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

  1. Objective response rate (ORR)

    The percentage of complete response (CR) and partial response (PR) in all the enrolled subjects from the date of the first administration (calculated by the optimum response during the entire study period)

    Measured: >4weeks

Secondary outcomes (4)

  1. Duration of Response(DoR)

    The duration from achieving effective treatment (CR or PR recorded for the first time) until definite relapse or progression for the first time.

    Measured: >3 months

  2. Progression-free survival(PFS)

    The duration from the first administration date until lymphoma progression (PD evaluated by imaging diagnosis) date or all-cause death date (whichever occurs first).

    Measured: 3 years

  3. Overall survival(OS)

    The duration from the first administration date until all-cause death date.

    Measured: 3 years

  4. Disease control rate(DCR)

    The percentage of CR and PR in all the enrolled subjects from the date of the first administration, including the subjects with CR, PRC or SD

    Measured: 3 years

Timeline

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

  1. First posted14 Dec 2018
  2. Study start2 Apr 2018
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (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
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03776279
Sponsor's protocol ID
PLM60-PTCL
Status last verified
Dec 2018
First submitted
13 Dec 2018
Last updated
14 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mitoxantrone Hydrochloride Liposome Injection in people with Relapsed or Refractory Peripheral T-cell and NK/T-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 29 inclusion and 27 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 14 Dec 2018. 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 Huiqiang Huang, Doctor (020-87343350, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: >4weeks). 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 NCT03776279.

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 14 Dec 2018.

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