Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05620862
Other study ID # CSPC-DED-Ly -K01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 25, 2022
Est. completion date June 1, 2025

Study information

Verified date August 2023
Source Sun Yat-sen University
Contact Yizhuo Zhang, PhD
Phone 020-87342460
Email zhangyzh@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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) .


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date June 1, 2025
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 2 Years to 21 Years
Eligibility Inclusion Criteria: - 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: 1. Lymphoblastic lymphoma 2. Anaplastic large T cell lymphoma 3. Burkitt's lymphoma 4. Diffuse large B-cell lymphoma 5. Peripheral T, NK/T cell lymphoma 6. Soft tissue sarcoma 7. Neuroblastoma 8. 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). Exclusion Criteria: - 1. The subject had previously received any of the following anti-tumor treatments: 1. Subjects who have been treated with mitoxantrone or mitoxantrone liposomes; 2. 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); 3. 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; 4. 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; - 3. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.); - 4. Heart function and disease meet one of the following conditions: 1. Long QTc syndrome or QTc interval > 480 ms; 2. Complete left bundle branch block, grade II or III atrioventricular block; 3. Serious and uncontrolled arrhythmias requiring drug treatment; 4. New York Heart Association grade = III; 5. Cardiac ejection fraction (LVEF)< 50%; 6. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mitoxantrone Hydrochloride Liposome
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)
Irinotecan
50mg/ m2,d1-5, 21 days per cycle
Vincristine
Vincristine 1.5mg/ m2,d1 , 21 days per cycle

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum-tolerated dose To investigate the safety and preliminary antitumor efficacy Up to 21 days
Primary peak time (Tmax) To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects Up to 18 weeks
Primary Maximum Plasma Concentration (Cmax) To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects Up to 18 weeks
Primary Area under the plasma concentration versus time curve (AUC) To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects Up to 18 weeks
Primary Elimination half life (t1/2) To evaluate the pharmacokinetics of mitoxantrone hydrochloride liposome at different doses in subjects Up to 18 weeks
Primary Incidence and severity of hematological adverse events To evaluate the incidence and severity of hematological adverse events in patients enrolled in phase Ib From date of randomization until 4 weeks after the last dose
Secondary Dose limiting toxicities To investigate the safety Up to 21 days
Secondary Objective response rate To investigate the preliminary antitumor efficacy of phase I dose escalation and pharmacokinetics study Up to 18 weeks
Secondary Complete response rate To investigate the preliminary antitumor efficacy of phase I dose escalation and pharmacokinetics study Up to 18 weeks
Secondary Progression free survival To investigate the preliminary antitumor efficacy of phase I dose escalation and pharmacokinetics study 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
Secondary The incidence and severity of AE and SAE To identify the incidence and severity of AE and SAE (NCI CTCAE v5.0) up to 42 weeks unless related serious adverse events need to be recorded indefinitely
Secondary 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 From date of randomization until 4 weeks after the last dose
See also
  Status Clinical Trial Phase
Recruiting NCT05151718 - Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents
Recruiting NCT02787876 - Pegteograstim in Children With Solid Tumors Phase 2
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Active, not recruiting NCT02520713 - The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study
Recruiting NCT05468359 - Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients Phase 1/Phase 2
Completed NCT04944875 - Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric Magnetic Resonance Imaging. N/A
Recruiting NCT03618381 - EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Phase 1
Recruiting NCT04897321 - B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR) Phase 1
Completed NCT05024331 - A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor
Active, not recruiting NCT04483778 - B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Phase 1
Active, not recruiting NCT04239040 - GVAX Plus Checkpoint Blockade in Neuroblastoma Phase 1
Recruiting NCT03739827 - Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
Recruiting NCT02339753 - Pharmacokinetic Study of Carboplatin in Pediatric Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT03222258 - Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients
Completed NCT02564198 - A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors Phase 1
Recruiting NCT03273829 - Study of Carfilzomib in Combination With Cyclophosphamide and Etoposide for Children With Relapsed or Refractory Solid Tumors and Leukemias Phase 1
Completed NCT03455140 - A Study Evaluating the Safety and Activity of Pegylated Recombinant Human Arginase (BCT-100) Phase 1/Phase 2
Completed NCT01853345 - iCAT for Recurrent/Refractory/HR Solid Tumors N/A
Active, not recruiting NCT03478462 - Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma Phase 1
Not yet recruiting NCT05322187 - Sequential PD-1/PD-L1 Inhibitor and LENvatinib in TLCT and Refractory Hepatoblastoma After Chemotherapy Phase 2/Phase 3