Angioimmunoblastic T-cell LymphomaPhase 1/2NCT06224842
Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of R/R AITL
A Phase 1/2 study testing mitoxantrone liposome 16 and azacitidine, mitoxantrone liposome 18 and azacitidine and mitoxantrone liposome 20 and azacitidine in people with Angioimmunoblastic T-cell Lymphoma, run by Huijing Wu at 1 site in China.
Trial summary
This study is an open-label, single-arm Phase Ib/II clinical trial designed to evaluate the safety and efficacy of the combination therapy with mitoxantrone liposome and azacitidine in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma(R/R AITL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- mitoxantrone liposome 16 and azacitidine, mitoxantrone liposome 18 and azacitidine and mitoxantrone liposome 20 and azacitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to Dec 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient fully understands this study and voluntarily participates,willingly chooses to participate, and signs the informed consent form (ICF), expressing the willingness to comply with and having the capability to complete all trial procedures;
- Male or female patients aged 18 to 75(including 18 and 70 years old);
- ECOG score 0-2 points;
- Angioimmunoblastic T-cell lymphoma (AITL) confirmed by histopathology;
- Relapsed/refractory patients who have received at least first-line anthracyclines containing systematic therapy in the past. Relapsed lymphoma refers to lymphoma that relapses after obtaining a complete response (CR) or partial response(PR) after initial therapy.Refractory lymphoma is defined as progressive disease in the first chemotherapy cycle 2, or stable disease in the first chemotherapy cycle 4;
- There must be at least one measurable lesion that meets the Lugano2014 standard: a lymph node lesion, with a measurable lymph node length greater than 1.5cm in diameter; Non lymph node lesions, measurable extranodal lesions with a length diameter greater than 1.0cm;
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- During patient screening, laboratory tests must meet the following requirements, and the patient should not have received any hematopoietic growth factors, platelet, or granulocyte transfusions within the 7 days prior to the hematological assessment during screening:
- neutrophil count ≥ 1.5 x 10^9/L, it can be relaxed to ≥ 1.0 x 10^9 /L in patients with bone marrow involvement;
- hemoglobin ≥ 90 g/L(without red blood cell transfusion within 14 days), it can be relaxed to ≥ 75 g/L in patients with bone marrow involvement;
- platelet count ≥ 75 x 10^9 /L, it can be relaxed to ≥ 50 x 10^9 /L in patients with bone marrow involvement;
- Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver invasion);
- AST and ALT ≤ 2.5 times the upper limit of normal values ,≤ 5 times the upper limit of normal values for patients with liver invasion;
- Serum creatinine ≤ 1.5 times the upper limit of normal value; 8.Qualified patients of reproductive capability (both males and females) must agree to use a reliable contraceptive method with their partners during the trial and for at least 7 months after the last dose of medication. Female patients of childbearing age must have a negative blood pregnancy test within 7 days prior to enrollment.
Who cannot join
- Central nervous system (CNS) involvement or patients with hemophagocytic syndrome.
- History of allergy to similar drugs and excipients of the investigational drug.
- Patients with the following conditions in their history of prior antitumor therapy:
- Patients previously treated withMitoxantrone liposome in combination with Azacitidine (patients who have received either of the treatments, or those who have received both treatments sequentially, are eligible).
- Previous treatment with adriamycin or other anthracyclines, with a total cumulative dose of adriamycin ≥ 350 mg/m2 (conversion for other anthracycline-type drugs: 1 mg of daunorubicin/pirarubicin/epirubicin is equivalent to 0.5 mg of adriamycin, and 1 mg of idarubicin is equivalent to 2 mg of anthracycline).
- Receipt of cytotoxic chemotherapy, radiotherapy, targeted therapy within 4 weeks, immunomodulators (thalidomide, lenalidomide) within 3 weeks, or hormonal or herbal therapy for lymphoma within 2 weeks before the first dose of the investigational drug.
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- Participation in other clinical trials and use of investigational drug treatment within 4 weeks before the first dose of the investigational drug.
- History of allogeneic hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation within the past 6 months.
- Unresolved toxic reactions from prior anti-tumor therapy with toxicity persisting at > Grade 1, excluding alopecia and pigmentation.
- Impaired cardiac function or significant cardiac diseases, including but not limited to:
- Occurrence of myocardial infarction, congestive heart failure, or viral myocarditis within the past 6 months before screening;
- Symptomatic cardiac diseases requiring treatment intervention, such as unstable angina, arrhythmias, etc.;
- New York Heart Association (NYHA) functional class II-IV;
- Cardiac ejection fraction (EF) detected by echocardiography below 50% or below the lower limit of the laboratory reference range at the research center;
- Ongoing history of myocarditis;
- QTc > 450 milliseconds or congenital QT interval prolongation syndrome.
- Active hepatitis B (HBV surface antigen positive and HBV-DNA titer > 2000 IU/ml) or hepatitis C (HCV antibody positive and HCV-RNA titer higher than the upper limit of the normal range at the research center).
- History of severe autoimmune diseases, immunodeficiency diseases, including HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- History of malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and in situ cervical carcinoma).
- Underwent major surgery within the past 6 weeks or is expected to undergo major surgery during the study period.
- Uncontrolled hypertension (defined as blood pressure reaching stage 3 hypertension standards despite antihypertensive treatment, with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg), or type 2 diabetes patients whose blood pressure cannot be controlled with oral hypoglycemic drugs and insulin therapy.
- Active bleeding history within the past 3 months before screening.
- History of mental illness or abuse and dependence on psychiatric drugs.
- Pregnant or lactating women.
- Other situations deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Huijing Wu, +86 13986195042, whjky122634@163.com
About this study
Official title: A Phase Ib/II Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of Relapsed/Refractory Angioimmunoblastic T-cell Lymphoma
This study is an open-label, single-arm Phase Ib/II clinical trial designed to evaluate the safety and efficacy of the combination therapy with mitoxantrone liposome and azacitidine in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma(R/R AITL). The study includes two parts: a dose escalation phase and a dose expansion phase, each comprising screening, treatment, and follow-up periods. In the dose escalation phase, the mitoxantrone liposome injection will start at a dose of 16 mg/m^2 on day1, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. After the treatment period, safety and survival information will be collected during the follow-up period. This study aims to comprehensively evaluate the safety and efficacy of mitoxantrone liposome in combination with azacitidine for the treatment of R/R AITL, exploring a combination therapy that offers higher survival benefits with limited adverse reactions and providing new therapeutic approaches for R/R AITL.
- Conditions
- Angioimmunoblastic T-cell Lymphoma
- Being tested
- mitoxantrone liposome 16 and azacitidine, mitoxantrone liposome 18 and azacitidine, mitoxantrone liposome 20 and azacitidine
- Medical subject headings
- Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitoxantrone liposome 16 and azacitidineDrug
The mitoxantrone liposome will be intravenous infused at a dose of 16mg/m^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days).
mitoxantrone liposome 18 and azacitidineDrug
The mitoxantrone liposome will be intravenous infused at a dose of 18mg/m^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days).
mitoxantrone liposome 20 and azacitidineDrug
The mitoxantrone liposome will be intravenous infused at a dose of 20mg/m^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days).
| Study group | Role | What they receive |
|---|---|---|
| mitoxantrone liposome and azacitidine treatment | Experimental | In the dose escalation phase, the mitoxantrone liposome will start at a dose of 16 mg/m^2 on day1 via intravenous infusion, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. Receives: Drug: mitoxantrone liposome 16 and azacitidine; Drug: mitoxantrone liposome 18 and azacitidine; Drug: mitoxantrone liposome 20 and azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The incidence and severity of treatment-emergent adverse events
Measured: Through study completion, an average of 2 year.
Secondary outcomes (3)
Objective Response Rate (ORR)
the percentage of patients who achieve complete response or partial response.
Measured: Through study completion, an average of 2 year.
Progression-Free Survival(PFS)
The time from the initiation of treatment until disease progression.
Measured: Through study completion, an average of 2 year.
Overall Survival(OS)
The time from the start of treatment until the patient's death from any cause.
Measured: Through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start12 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioimmunoblastic T-cell LymphomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huijing Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Xisike Clinical Oncology Research Foundation, CSPC-NBP Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Huijing Wu, Hubei Cancer Hospital
- Investigators
- Huijing Wu, Principal investigator, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224842
- Sponsor's protocol ID
- MitAITL
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of Relapsed/Refractory Angioimmunoblastic T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06224842
- Acronym / sponsor ID
- MitAITL
- Conditions
- Angioimmunoblastic T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Huijing WuUniversity, hospital or other
- Collaborators
- Beijing Xisike Clinical Oncology Research Foundation, CSPC-NBP Pharmaceutical Co., Ltd.
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jan 2024 (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.
This study is an open-label, single-arm Phase Ib/II clinical trial designed to evaluate the safety and efficacy of the combination therapy with mitoxantrone liposome and azacitidine in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma(R/R AITL). The study includes two parts: a dose escalation phase and a dose expansion phase, each comprising screening, treatment, and follow-up periods. In the dose escalation phase, the mitoxantrone liposome injection will start at a dose of 16 mg/m^2 on day1, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. After the treatment period, safety and survival information will be collected during the follow-up period. This study aims to comprehensively evaluate the safety and efficacy of mitoxantrone liposome in combination with azacitidine for the treatment of R/R AITL, exploring a combination therapy that offers higher survival benefits with limited adverse reactions and providing new therapeutic approaches for R/R AITL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mitoxantrone liposome and azacitidine treatment | Experimental | Drug: mitoxantrone liposome 16 and azacitidine, Drug: mitoxantrone liposome 18 and azacitidine, Drug: mitoxantrone liposome 20 and azacitidineIn the dose escalation phase, the mitoxantrone liposome will start at a dose of 16 mg/m^2 on day1 via intravenous infusion, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient fully understands this study and voluntarily participates,willingly chooses to participate, and signs the informed consent form (ICF), expressing the willingness to comply with and having the capability to complete all trial procedures;
- Male or female patients aged 18 to 75(including 18 and 70 years old);
- ECOG score 0-2 points;
- Angioimmunoblastic T-cell lymphoma (AITL) confirmed by histopathology;
- Relapsed/refractory patients who have received at least first-line anthracyclines containing systematic therapy in the past. Relapsed lymphoma refers to lymphoma that relapses after obtaining a complete response (CR) or partial response(PR) after initial therapy.Refractory lymphoma is defined as progressive disease in the first chemotherapy cycle 2, or stable disease in the first chemotherapy cycle 4;
Key exclusion criteria (25 listed)
- Central nervous system (CNS) involvement or patients with hemophagocytic syndrome.
- History of allergy to similar drugs and excipients of the investigational drug.
- Patients with the following conditions in their history of prior antitumor therapy:
- Active hepatitis B (HBV surface antigen positive and HBV-DNA titer > 2000 IU/ml) or hepatitis C (HCV antibody positive and HCV-RNA titer higher than the upper limit of the normal range at the research center).
- History of severe autoimmune diseases, immunodeficiency diseases, including HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
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 liposome 16 and azacitidineThe mitoxantrone liposome will be intravenous infused at a dose of 16mg/m^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). | Drug | mitoxantrone liposome and azacitidine treatment |
| mitoxantrone liposome 18 and azacitidineThe mitoxantrone liposome will be intravenous infused at a dose of 18mg/m^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). | Drug | mitoxantrone liposome and azacitidine treatment |
| mitoxantrone liposome 20 and azacitidineThe mitoxantrone liposome will be intravenous infused at a dose of 20mg/m^2 on day1 , combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). | Drug | mitoxantrone liposome and azacitidine treatment |
Primary outcome
Adverse events
Time frame: Through study completion, an average of 2 year.
The incidence and severity of treatment-emergent adverse events
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 2 year.
Progression-Free Survival(PFS)
Time frame: Through study completion, an average of 2 year.
Overall Survival(OS)
Time frame: Through study completion, an average of 2 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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.
Huijing Wu principal investigator
Hubei Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mitoxantrone liposome 16 and azacitidine, mitoxantrone liposome 18 and azacitidine and mitoxantrone liposome 20 and azacitidine in people with Angioimmunoblastic T-cell Lymphoma, run by Huijing Wu 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 13 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 25 Jan 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 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 Chang Xue (+86 17152776860, xuechang91@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through study completion, an average of 2 year.). 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 25 Jan 2024.