Pediatric Solid TumorPhase 1NCT05620862
Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome, Irinotecan and Vincristine in people with Pediatric Solid Tumor, run by Sun Yat-sen University at 1 site in China.
Trial summary
Phase I dose escalation clinical trial: to explore the dose limiting toxicity (DLT) of mitoxantrone hydrochloride liposome injection in the treatment of children with relapsed and refractory lymphoma and solid tumors. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Pediatric Solid Tumor
- What is being tested?
- Mitoxantrone Hydrochloride Liposome, Irinotecan and Vincristine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2022to 1 Jun 2025
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Subjects fully understand and voluntarily participate in this study and sign the informed consent form (ICF);
- 2. 2-21 years old;
- 3. Expected survival ≥ 3 months;
- 4. Subjects with histologically confirmed diagnosis of relapsed and refractory lymphoma and solid tumors, which is one of the following subtypes:
- Lymphoblastic lymphoma
- Anaplastic large T cell lymphoma
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- Burkitt's lymphoma
- Diffuse large B-cell lymphoma
- Peripheral T, NK/T cell lymphoma
- Soft tissue sarcoma
- Neuroblastoma
- Other subtypes of lymphoma or solid tumors that the investigators believe can be included
- 5. Relapsed lymphoma is defined as the lymphoma that relapse after obtaining complete response (CR) after initial chemotherapy; Refractory lymphoma subjects meet one of the following conditions: 1) The tumor shrinks <50% or disease progression after 4 cycles of standard chemotherapy,; 2) CR after standard chemotherapy, but relapse within half a year; 3) 2 or more relapses after CR; 4) relapse after hematopoietic stem cell transplantation;
- 6. Lymphoma subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length should be > 1.5cm; For non-lymph node lesions, the length should be > 1.0cm;
- 7. Solid tumors must have tumor lesions measurable by CT or MRI;
- 8. ECOG Performance Status: 0-2;
- 9. Bone marrow function: Absolute neutrophil count ≥1.5×109/L, Platelet count ≥75×109/L, Hemoglobin ≥ 80g/L (Absolute neutrophil can be relaxed to ≥ 1.0×109/L, Platelet count can be relaxed to ≥50×109/L, Hemoglobin can be relaxed to ≥75 g/L in subjects with poor bone-marrow reserve);
- 10. Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN (≤ 3×ULN for subjects with liver metastases).
Who cannot join
- 1. The subject had previously received any of the following anti-tumor treatments:
- Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;
- Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin);
- Subjects who received anti-tumor treatment (including chemotherapy, targeted therapy, glucocorticoid, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received trial drugs;
- Subjects who received autologous hematopoietic stem cell transplantation within 100 days after the first medication or allogeneic hematopoietic stem cell transplantation.
- 2. Hypersensitivity to any study drug or its components;
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- 3. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.);
- 4. Heart function and disease meet one of the following conditions:
- Long QTc syndrome or QTc interval > 480 ms;
- Complete left bundle branch block, grade II or III atrioventricular block;
- Serious and uncontrolled arrhythmias requiring drug treatment;
- New York Heart Association grade ≥ III;
- Cardiac ejection fraction (LVEF)< 50%;
- A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.
- 5. Hepatitis B and hepatitis C active infection (plus HBV DNA if one positive for hepatitis B surface antigen or core antibody and HBV DNA more than 1×103 copy/mL excluded; plus HCV RNA if hepatitis C antibody positive and HCV RNA more than 1×103 copy/mL exclude);
- 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- 7. Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past five years);
- 8. Subjects suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
- 9. Pregnant and lactating women and childbearing age patients unwilling to take contraceptive measures;
- 10. Unsuitable subjects for this study determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Phase I dose escalation clinical trial: to explore the dose limiting toxicity (DLT) of mitoxantrone hydrochloride liposome injection in the treatment of children with relapsed and refractory lymphoma and solid tumors.
Pharmacokinetics clinical trial: to observe the pharmacokinetics of mitoxantrone hydrochloride liposomes in children with relapsed and refractory lymphoma and solid tumors.
To evaluate the safety and efficacy of mitoxantrone hydrochloride liposomes in children with lymphoma and solid tumors.
Read the detailed description
This is a phase I dose escalation and pharmacokinetics clinical trial to evaluate the safety and efficacy of mitoxantrone hydrochloride liposomes in children with lymphoma and solid tumors. In the phase Ia dose escalation study, patients with relapsed and refractory lymphoma and solid tumors will be treated with mitoxantrone hydrochloride liposome alone or combined treatment at the dose of 16 mg/m2, 20 mg/m2 and 24 mg/m2, each cohort wil enroll 9~18 children. Simultaneously 6~15 cases were added for pharmacokinetic study to ensure 8 cases are included in each dose group with the same mitoxantrone hydrochloride liposome dose. In phase Ib, patients received the combination therapy of mitoxantrone hydrochloride liposome at the MTD dose (24mg/m2) .
- Conditions
- Pediatric Solid Tumor
- Being tested
- Mitoxantrone Hydrochloride Liposome, Irinotecan, Vincristine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride LiposomeDrug
In phase Ia, mitoxantrone hydrochloride liposome will be administered by an intravenous infusion at three doses of 16 mg/m2, 20 mg/m2 and 24 mg/m2 . In phase Ib, mitoxantrone hydrochloride liposome will be administered by an intravenous infusion of 24mg/m2. Up to 6 cycles (21 days per cycle)
IrinotecanDrug
50mg/ m2，d1-5, 21 days per cycle
VincristineDrug
Vincristine 1.5mg/ m2，d1 , 21 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| mitoxantrone hydrochloride liposome alone or combined with Irinotecan+Vincristine | Experimental | In phase Ia, patients with relapsed and refractory lymphoma and solid tumors will receive mitoxantrone hydrochloride liposome alone (at three doses of 16 mg/m2, 20 mg/m2 and 24 mg/m2, ) or combination of Irinotecan 50mg/ m2，d1-5, Vincristine 1.5mg/ m2，d1 for up to 6 cycles (21 days per cycle). In phase Ib, patients will recive mitoxantrone hydrochloride liposome 24 mg/m2, combination of Irinotecan 50mg/ m2，d1-5, Vincristine 1.5mg/ m2 Receives: Drug: Mitoxantrone Hydrochloride Liposome; Drug: Irinotecan; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose
To investigate the safety and preliminary antitumor efficacy
Measured: Up to 21 days
peak time (Tmax)
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Measured: Up to 18 weeks
Maximum Plasma Concentration (Cmax)
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Measured: Up to 18 weeks
Area under the plasma concentration versus time curve (AUC)
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Measured: Up to 18 weeks
Elimination half life (t1/2)
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Measured: Up to 18 weeks
Incidence and severity of hematological adverse events
To evaluate the incidence and severity of hematological adverse events in patients enrolled in phase Ib
Measured: From date of randomization until 4 weeks after the last dose
Secondary outcomes (6)
Dose limiting toxicities
To investigate the safety
Measured: Up to 21 days
Objective response rate
To investigate the preliminary antitumor efficacy of phase I dose escalation and pharmacokinetics study
Measured: Up to 18 weeks
Complete response rate
To investigate the preliminary antitumor efficacy of phase I dose escalation and pharmacokinetics study
Measured: Up to 18 weeks
Progression free survival
To investigate the preliminary antitumor efficacy of phase I dose escalation and pharmacokinetics study
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 70 weeks
The incidence and severity of AE and SAE
To identify the incidence and severity of AE and SAE (NCI CTCAE v5.0)
Measured: up to 42 weeks unless related serious adverse events need to be recorded indefinitely
Incidence and severity of non-hematological adverse events
The incidence and severity of non-hematological adverse events were evaluated in patients enrolled in Phase Ib
Measured: From date of randomization until 4 weeks after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start25 Oct 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620862
- Sponsor's protocol ID
- CSPC-DED-Ly -K01
- Status last verified
- Jul 2024
- First submitted
- 8 Nov 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors
- ClinicalTrials.gov ID
- NCT05620862
- Acronym / sponsor ID
- CSPC-DED-Ly -K01
- Conditions
- Pediatric Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I dose escalation clinical trial: to explore the dose limiting toxicity (DLT) of mitoxantrone hydrochloride liposome injection in the treatment of children with relapsed and refractory lymphoma and solid tumors.
Pharmacokinetics clinical trial: to observe the pharmacokinetics of mitoxantrone hydrochloride liposomes in children with relapsed and refractory lymphoma and solid tumors.
To evaluate the safety and efficacy of mitoxantrone hydrochloride liposomes in children with lymphoma and solid tumors.
Detailed description
This is a phase I dose escalation and pharmacokinetics clinical trial to evaluate the safety and efficacy of mitoxantrone hydrochloride liposomes in children with lymphoma and solid tumors. In the phase Ia dose escalation study, patients with relapsed and refractory lymphoma and solid tumors will be treated with mitoxantrone hydrochloride liposome alone or combined treatment at the dose of 16 mg/m2, 20 mg/m2 and 24 mg/m2, each cohort wil enroll 9~18 children. Simultaneously 6~15 cases were added for pharmacokinetic study to ensure 8 cases are included in each dose group with the same mitoxantrone hydrochloride liposome dose. In phase Ib, patients received the combination therapy of mitoxantrone hydrochloride liposome at the MTD dose (24mg/m2) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mitoxantrone hydrochloride liposome alone or combined with Irinotecan+Vincristine | Experimental | Drug: Mitoxantrone Hydrochloride Liposome, Drug: Irinotecan, Drug: VincristineIn phase Ia, patients with relapsed and refractory lymphoma and solid tumors will receive mitoxantrone hydrochloride liposome alone (at three doses of 16 mg/m2, 20 mg/m2 and 24 mg/m2, ) or combination of Irinotecan 50mg/ m2，d1-5, Vincristine 1.5mg/ m2，d1 for up to 6 cycles (21 days per cycle). In phase Ib, patients will recive mitoxantrone hydrochloride liposome 24 mg/m2, combination of Irinotecan 50mg/ m2，d1-5, Vincristine 1.5mg/ m2 |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- 1. Subjects fully understand and voluntarily participate in this study and sign the informed consent form (ICF);
- 2. 2-21 years old;
- 3. Expected survival ≥ 3 months;
- 4. Subjects with histologically confirmed diagnosis of relapsed and refractory lymphoma and solid tumors, which is one of the following subtypes:
- 5. Relapsed lymphoma is defined as the lymphoma that relapse after obtaining complete response (CR) after initial chemotherapy; Refractory lymphoma subjects meet one of the following conditions: 1) The tumor shrinks <50% or disease progression after 4 cycles of standard chemotherapy,; 2) CR after standard chemotherapy, but relapse within half a year; 3) 2 or more relapses after CR; 4) relapse after hematopoietic stem cell transplantation;
Key exclusion criteria (20 listed)
- 1. The subject had previously received any of the following anti-tumor treatments:
- 2. Hypersensitivity to any study drug or its components;
- 3. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.);
- 4. Heart function and disease meet one of the following conditions:
- 5. Hepatitis B and hepatitis C active infection (plus HBV DNA if one positive for hepatitis B surface antigen or core antibody and HBV DNA more than 1×103 copy/mL excluded; plus HCV RNA if hepatitis C antibody positive and HCV RNA more than 1×103 copy/mL exclude);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone Hydrochloride LiposomeIn phase Ia, mitoxantrone hydrochloride liposome will be administered by an intravenous infusion at three doses of 16 mg/m2, 20 mg/m2 and 24 mg/m2 . In phase Ib, mitoxantrone hydrochloride liposome will be administered by an intravenous infusion of 24mg/m2. Up to 6 cycles (21 days per cycle) | Drug | mitoxantrone hydrochloride liposome alone or combined with Irinotecan+Vincristine |
| Irinotecan50mg/ m2，d1-5, 21 days per cycle | Drug | mitoxantrone hydrochloride liposome alone or combined with Irinotecan+Vincristine |
| VincristineVincristine 1.5mg/ m2，d1 , 21 days per cycle | Drug | mitoxantrone hydrochloride liposome alone or combined with Irinotecan+Vincristine |
Primary outcome
Maximum-tolerated dose
Time frame: Up to 21 days
To investigate the safety and preliminary antitumor efficacy
peak time (Tmax)
Time frame: Up to 18 weeks
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Maximum Plasma Concentration (Cmax)
Time frame: Up to 18 weeks
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 18 weeks
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Elimination half life (t1/2)
Time frame: Up to 18 weeks
To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects
Incidence and severity of hematological adverse events
Time frame: From date of randomization until 4 weeks after the last dose
To evaluate the incidence and severity of hematological adverse events in patients enrolled in phase Ib
6 secondary outcomes
Dose limiting toxicities
Time frame: Up to 21 days
Objective response rate
Time frame: Up to 18 weeks
Complete response rate
Time frame: Up to 18 weeks
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 70 weeks
The incidence and severity of AE and SAE
Time frame: up to 42 weeks unless related serious adverse events need to be recorded indefinitely
Incidence and severity of non-hematological adverse events
Time frame: From date of randomization until 4 weeks after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitoxantrone Hydrochloride Liposome, Irinotecan and Vincristine in people with Pediatric Solid Tumor, run by Sun Yat-sen University 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 18 inclusion and 20 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 9 Jul 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 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?
Results are not available in the source record.
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?
Maximum-tolerated dose (time frame: Up to 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.