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Non-Hodgkin's LymphomaPhase 1/2NCT02856685

A Study of Mitoxantrone Hydrochloride Liposome Infusion

A Phase 1/2 study testing Mitoxantrone Hydrochloride Liposome in people with Non-Hodgkin's Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 Phase 1/2, open-label, multicenter study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Mitoxantrone Hydrochloride Liposome
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Aug 2016to May 2018
Phase
Phase 1/2
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

  • Signed informed consent prior to study-related procedures
  • Patients with histologically confirmed, relapsed or refractory NHL after treatment with standard regimens. Patients with both intermediate and aggressive subtypes (for example, diffuse large B-cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, anaplastic large-cell lymphoma) and indolent subtypes that require treatment (for example, follicular lymphoma, small lymphocytic lymphoma) will be enrolled into the Phase 1 part of the study; Patients with indolent types of NHL must have been assessed as needing further treatment by the Investigator, based on the presence of lymphoma-related symptoms or the presence of significant tumor burden;(Phase 1)
  • Adult patients with histologically confirmed relapsed or refractory aggressive NHL (including diffuse large B-cell lymphoma, peripheral T-cell lymphoma, and natural killer cell lymphoma) who were treated with standard regimens and for whom there is no known effective therapy;(Phase 2)
  • > 4 weeks since last cycle of chemotherapy prior to the study drug administration;
  • Recovered from all toxicity from prior chemotherapy at Investigator's discretion;
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2;
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  • Patients who have sufficient baseline organ function and whose laboratory data meet the following criteria at enrolment: Absolute neutrophil count ≥ 1.5 x 109/L; Platelets ≥ 75 x 109/L; Hemoglobin ≥ 90 g/L (unless bone marrow involvement is present); Liver function: Serum bilirubin ≤ 1.2 x upper limit of normal (ULN), Aspartate aminotransferase and alanine aminotransferase ≤ 3 x ULN without liver metastases or ≤ 5 x ULN if the patient has documented liver metastases; International normalization ratio < 1.3 if the patient is not on anticoagulants or < 3 if the patient is on anticoagulants o Serum creatinine ≤ 1.5 mg/dL or estimated glomerular filtration rate > 40 mL/min/m2;
  • Left ventricular ejection fraction (LVEF) > 50%;
  • Life expectancy ≥ 12 weeks;
  • Women of childbearing potential must have a negative pregnancy test prior to study entry, and agree to use adequate contraception from study entry through at least 3 months after the last dose of study drug. Adequate methods of contraception for patient or partner include vasectomized partner (at least 6 months prior to dosing); intrauterine device; condom with spermicidal gel, foam, cream, film, or suppository; diaphragm with spermicidal gel, foam, cream, film, or suppository; or cervical cap with spermicidal gel, foam, cream, film, or suppository.A female patient of non-childbearing potential must have had at least 12 continuous months of natural (spontaneous) amenorrhea, follicle-stimulating hormone level > 40 mIU/mL at Screening, or have had surgical bilateral oophorectomy or a hysterectomy > 6 weeks prior to Screening;
  • A male patient must agree to use adequate contraception (male condom with spermicide; sterile sexual partner; or female sexual partner who uses an intrauterine device with spermicide, a female condom with spermicide, a contraceptive sponge with spermicide, an intravaginal system, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives) from study entry through at least 3 months after the last dose of study drug;
  • Involved lymph nodes or masses should be measurable in at least 2 perpendicular dimensions and be > 1.5 cm in the longest of the perpendicular dimensions (based on Cheson et al 2014) (Additional Inclusion Criteria for Phase 2);
  • Agree to undergo pretreatment bone marrow biopsy and post-treatment bone marrow biopsy when required to confirm response (Additional Inclusion Criteria for Phase 2).

Who cannot join

  • Pregnant or breastfeeding women;
  • Patients with a history of allergy to anthracyclines or liposomal drugs;
  • Prior treatment with mitoxantrone;
  • Treatment with doxorubicin with a total cumulative dose > 300 mg/m2, or epirubicin with the total cumulative dose > 500 mg/m2;
  • Investigational treatment within 4 weeks of the start of PLM60;
  • Systemic chemotherapy within 4 weeks of the start of PLM60;
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  • Radiotherapy (≥25 % of bone marrow) within 4 weeks of the start of PLM60;
  • Radio-/toxin-immunoconjugates within 42 days of the start of PLM60;
  • Prior allogeneic stem cell transplantation;
  • Known central nervous system involvement by NHL;
  • Patients who have the following types of cardiac impairment at the time of enrolment: New York Heart Association class III or IV heart disease; Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to enrolment; An LVEF by echocardiogram or multi-gated acquisition (MUGA) scan < 50%; QT interval prolongation (> 450 ms in males, > 470 ms in females);
  • A past history of cardiac disease caused by anthracyclines;
  • History of malignancy other than NHL in the past 3 years prior to enrolment, except for adequately treated non-melanoma skin cancer or in situ cervical cancer;
  • Patients with evidence of an active infection including the following: Patients being treated with antibiotics for an active infection at the time of enrolment; Patients who have evidence of active hepatitis C or chronic active hepatitis B; Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection/ acquired immunodeficiency syndrome (AIDS);
  • Other severe or poorly controlled illness or circumstance that would interfere with evaluation of key study endpoints or which would put the patient at risk from participating in the study in the opinion of the Investigator.

Trial locations and contacts

1 site in 1 country.

Nashat Y Gabrail, M.D. contact

(330) 492-3345

United States1 site, 1 recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio

    Nashat Y Gabrail, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2 Study of Mitoxantrone Hydrochloride Liposome Infusion in Patients With Non-Hodgkin's Lymphoma

This is a Phase 1/2, open-label, multicenter study.

Read the detailed description

The Phase 1 part of this study is designed to identify the MTD and RP2D, and to characterize the safety, tolerability, and PK. The Phase 1 part of the study will include 2 parts: dose escalation and dose expansion.

After confirmation of the RP2D in the expansion part of Phase 1, enrolment into the Phase 2 part of the study will begin. The primary objective of the Phase 2 part of the study is to evaluate the efficacy of the investigational drug when administered to patients with relapsed or refractory NHL.

Being tested
Mitoxantrone Hydrochloride Liposome
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • Mitoxantrone Hydrochloride LiposomeDrug

    Also called PLM60

    Mitoxantrone Hydrochloride Liposome will be administered via IV infusion over 60 minutes once at the beginning (Day 1) of each 28-day cycle

Study groups in NCT02856685
Study groupRoleWhat they receive
PLM60ExperimentalMitoxantrone Hydrochloride Liposome
Receives: Drug: Mitoxantrone Hydrochloride Liposome

What is being measured

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

  1. Maximum Tolerated Dose (MTD)(Phase 1)

    Phase 1 -MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose limiting toxicity is based on adverse events and includes unacceptable hematologic toxicity, unacceptable non-hematologic toxicity, and laboratory abnormalities of Grade 4 or higher.

    Measured: 28 day cycle of therapy

  2. Objective response rate (ORR; complete response + partial response [CR + PR])(Phase 2)

    Tumor response and progression will be evaluated every 8 weeks according to the Lugano Classification (Cheson et al 2014).

    Measured: Approximately 2 years

Secondary outcomes (1)

  1. Maximum serum concentration (Cmax) of PLM60

    Measured: Approximately 1 years

Timeline

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

  1. First posted5 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionMay 2018 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856685
Sponsor's protocol ID
CSPC-AB-NHL-01
Status last verified
Jul 2016
First submitted
1 Aug 2016
Last updated
22 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mitoxantrone Hydrochloride Liposome in people with Non-Hodgkin's Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in United States.

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 13 inclusion and 15 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 22 Aug 2016. 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 United States. 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 combined 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.

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 Nashat Y Gabrail, M.D. ((330) 492-3345), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD)(Phase 1) (time frame: 28 day cycle of therapy). The study lists 2 primary outcomes in all. 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 NCT02856685.

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 22 Aug 2016.

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