TreatmentPhase 1/2NCT05441761
Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL
A Phase 1/2 study testing liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin in people with Treatment and Peripheral T-cell Lymphoma, run by Peking Union Medical College Hospital at 5 sites in China.
Trial summary
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy mitoxantrone hydrochloride liposome in combination with gemcitabine, dexamethasone, and cisplatin in relapsed/refractory peripheral T-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Treatment, Peripheral T-cell Lymphoma
- What is being tested?
- liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- 1 May 2022to 1 May 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
- Subjects fully understand and voluntarily participate in this study and sign informed consent
- Age ≥18, ≤75 years, no gender limitation
- Expected survival ≥ 3 months;
- Histologically confirmed diagnosis of peripheral T-cell lymphoma, is one of the following subtypes (1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) (2) Angioimmunoblastic T-cell lymphoma (AITL) (3) Anaplastic large cell lymphoma (ALCL), ALK+ (4) Anaplastic large cell lymphoma (ALCL), ALK- (5) Other subtypes of PTCL that the researcher considered to be included in the group;
- The criteria for relapsed/refractory lymphoma: Relapsed lymphoma is defined as lymphoma that relapsed after a complete response (CR) was achieved with initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following criteria: 1) tumor reduction < 50% or disease progression after 4 cycles of standard regimens of chemotherapy; 2) CR was achieved by standard chemotherapy, but relapse occurred within six months; 3) Two or more times of recurrence after CR; 4) Relapse after hematopoietic stem cell transplantation;
- There must be at least one evaluable or measurable lesion meeting lugano2014 criteria: for lymph node lesions, the length and diameter should be > 1.5cm; For non lymph node lesions, the length and diameter should be > 1.0cm;
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- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；
- Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/L, Hemoglobin(HB)≥ 80g/L(Bone marrow invasive patient ANC≥1.0×109/L,PLT≥50×109/L,HB≥75 g/L)
- Liver and kidney function：Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) , The liver invasion≤3.0×ULN）;Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN , The liver invasion≤5.0×ULN; Serum creatinine (Scr) ≤1.5× ULN
Who cannot join
- The subject had previously received any of the following anti-tumor treatments:
- Those who have previously received mitoxantrone or mitoxantrone liposomes;
- Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin is more than 550 mg/m2 (1 mg doxorubicin converted from other anthracycline drugs is equivalent to 2 mg epirubicin);
- Have received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drugs;
- Patients who have received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days of the first medication;
- Hypersensitivity to any study drug or its components;
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- Non controlled systemic diseases (such as active infection, non controlled hypertension, diabetes, etc.)
- Heart function and disease meet one of the following conditions:
- Long QT c 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.
- Baseline NT-proBNP is greater than 800pg/ mL, cTnI is greater than the normal upper limit of our center, and the retest in three days which is still higher than the above range.
- Hepatitis B, Hepatitis C infection in active stage (if there is a positive hepatitis B surface antigen or core antibody, additional test HBV DNA, Hepatitis B virus DNA more than 1x103 copies /mL excluded; If HCV anti-body is positive, add test for HCV RNA, and exclude HCV RNA over 1x103 copies /mL)
- Past or current co-occurrence of other malignancies (except effectively controlled non-melanoma cutaneous basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies effectively controlled without treatment within the past five years)
- Have primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
- Pregnant and lactating women and patients of childbearing age who do not want to use contraception;
- Conditions that other researchers deem inappropriate to participate in this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Beijing Hospital
Beijing
Hui Liu, Dr, +8613520618812, liuhui8140@126.com
- Not yet recruiting
Beijing Luhe Hospital, Capital Medical University
Beijing
Hebing Zhou, Dr, +8613681210186, zhbyffs@126.com
- Not yet recruiting
China-Japan Friendship Hospital
Beijing
Zhenling Li, Dr, +8613520114408, zryyxy2013@163.com
- Recruiting
Peking Union Medical College Hospital
Beijing
Daobin Zhou, Dr, +8613901113623, Zhoudb@pumch.cn
Chong Wei, +8613521760705, QH5035@163.com
- Not yet recruiting
Peking University First Hospital
Beijing
Yujun Dong, Dr, +8618210264969, dongy@hsc.pku.edu.cn
About this study
Official title: Phase I/II Clinical Study of Mitoxantrone Hydrochloride Liposomes in Combination With Gemcitabine, Dexamethasone, and Cisplatin in Relapsed/Refractory Peripheral T-cell Lymphoma
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy mitoxantrone hydrochloride liposome in combination with gemcitabine, dexamethasone, and cisplatin in relapsed/refractory peripheral T-cell lymphoma
Read the detailed description
This is a prospective, open-label, single arm, multicenter clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory peripheral T-cell lymphoma. Liposomal mitoxantrone hydrochloride will be given on day 1 at three different doses (12 mg/m2，16 mg/m2, 20 mg/m2) and be combined with gemcitabine, dexamethasone, and cisplatin. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned. An dose expansion study of mitoxantrone hydrochloride liposome at RP2D dose level combined with gemcitabine, dexamethasone, and cisplatin was conducted to explore the efficacy and safety tolerance of the combined regimen.
- Conditions
- Treatment, Peripheral T-cell Lymphoma
- Being tested
- liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatinDrug
Drug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Drug: gemcitabine (1000 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Drug: dexamethasone (40 mg) will be administered on day 1-4 of each 21-day cycle.
Drug: cisplatin (75 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| liposomal mitoxantrone hydrochloride | Experimental | Patients with recurrent and refractory peripheral T-cell lymphoma will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with gemcitabine, dexamethasone, and cisplatin for 6 cycles (planned) (21 days per cycle). Receives: Drug: liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose（RP2D）
To identify the RP2D
Measured: 1 year
Objective response rate (ORR)
The ORR was defined as the proportion of patients who achieved CR or PR
Measured: 3 year
Secondary outcomes (7)
Dose limited toxicities (DLTs)
Measured: 1 year
maximum-tolerated dose(MTD)
Measured: 1 year
The incidence of AE and SAE
Measured: 3 year
Complete response rate (CRR)
Measured: 3 year
Duration of Response（DOR）
Measured: 3 year
progression-free survival（PFS）
Measured: 3 year
Overall survival（OS)
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 May 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441761
- Sponsor's protocol ID
- PUMCH-NHL-014
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Study of Mitoxantrone Hydrochloride Liposomes in Combination With Gemcitabine, Dexamethasone, and Cisplatin in Relapsed/Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05441761
- Acronym / sponsor ID
- PUMCH-NHL-014
- Conditions
- Treatment, Peripheral T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 1 Jul 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.
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy mitoxantrone hydrochloride liposome in combination with gemcitabine, dexamethasone, and cisplatin in relapsed/refractory peripheral T-cell lymphoma
Detailed description
This is a prospective, open-label, single arm, multicenter clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory peripheral T-cell lymphoma. Liposomal mitoxantrone hydrochloride will be given on day 1 at three different doses (12 mg/m2，16 mg/m2, 20 mg/m2) and be combined with gemcitabine, dexamethasone, and cisplatin. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned. An dose expansion study of mitoxantrone hydrochloride liposome at RP2D dose level combined with gemcitabine, dexamethasone, and cisplatin was conducted to explore the efficacy and safety tolerance of the combined regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liposomal mitoxantrone hydrochloride | Experimental | Drug: liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatinPatients with recurrent and refractory peripheral T-cell lymphoma will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with gemcitabine, dexamethasone, and cisplatin for 6 cycles (planned) (21 days per cycle). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects fully understand and voluntarily participate in this study and sign informed consent
- Age ≥18, ≤75 years, no gender limitation
- Expected survival ≥ 3 months;
- Histologically confirmed diagnosis of peripheral T-cell lymphoma, is one of the following subtypes (1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) (2) Angioimmunoblastic T-cell lymphoma (AITL) (3) Anaplastic large cell lymphoma (ALCL), ALK+ (4) Anaplastic large cell lymphoma (ALCL), ALK- (5) Other subtypes of PTCL that the researcher considered to be included in the group;
- The criteria for relapsed/refractory lymphoma: Relapsed lymphoma is defined as lymphoma that relapsed after a complete response (CR) was achieved with initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following criteria: 1) tumor reduction < 50% or disease progression after 4 cycles of standard regimens of chemotherapy; 2) CR was achieved by standard chemotherapy, but relapse occurred within six months; 3) Two or more times of recurrence after CR; 4) Relapse after hematopoietic stem cell transplantation;
Key exclusion criteria (20 listed)
- The subject had previously received any of the following anti-tumor treatments:
- Hypersensitivity to any study drug or its components;
- Non controlled systemic diseases (such as active infection, non controlled hypertension, diabetes, etc.)
- Heart function and disease meet one of the following conditions:
- Hepatitis B, Hepatitis C infection in active stage (if there is a positive hepatitis B surface antigen or core antibody, additional test HBV DNA, Hepatitis B virus DNA more than 1x103 copies /mL excluded; If HCV anti-body is positive, add test for HCV RNA, and exclude HCV RNA over 1x103 copies /mL)
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 |
|---|---|---|
| liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatinDrug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: gemcitabine (1000 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: dexamethasone (40 mg) will be administered on day 1-4 of each 21-day cycle. Drug: cisplatin (75 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | liposomal mitoxantrone hydrochloride |
Primary outcome
Recommended Phase II Dose（RP2D）
Time frame: 1 year
To identify the RP2D
Objective response rate (ORR)
Time frame: 3 year
The ORR was defined as the proportion of patients who achieved CR or PR
7 secondary outcomes
Dose limited toxicities (DLTs)
Time frame: 1 year
maximum-tolerated dose(MTD)
Time frame: 1 year
The incidence of AE and SAE
Time frame: 3 year
Complete response rate (CRR)
Time frame: 3 year
Duration of Response（DOR）
Time frame: 3 year
progression-free survival（PFS）
Time frame: 3 year
Overall survival（OS)
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- 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.
5 sites 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 liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin in people with Treatment and Peripheral T-cell Lymphoma, run by Peking Union Medical College Hospital at 5 sites 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 9 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Daobin Zhou, Dr (+8613901113623, Zhoudb@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose（RP2D） (time frame: 1 year). 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?
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 1 Jul 2022.