Non Hodgkin LymphomaPhase 1NCT05299164
GVM±R in Patients With Relapsed or Refractory Aggressive NHL
A Phase 1 study testing Liposomal Mitoxantrone Hydrochloride dose level 1, Liposomal Mitoxantrone Hydrochloride dose level 2 and Liposomal Mitoxantrone Hydrochloride dose level 3 in people with Non Hodgkin Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, dose-escalation clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- Liposomal Mitoxantrone Hydrochloride dose level 1, Liposomal Mitoxantrone Hydrochloride dose level 2 and Liposomal Mitoxantrone Hydrochloride dose level 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2022to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 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 the informed consent
- Age ≥18, ≤70years, no gender limitation
- Expected survival ≥ 3 months;
- Histologically confirmed diagnosis of aggressive NHL.
- Subjects with relapsed or refractory NHL. Relapsed disease is defined as the disease relapsing after CR or PR, and the duration of prior response is more than 6 months. Refractory disease can be confirmed if any of the following conditions are met: 1) no PR or CR has been obtained after previous treatment; 2) CR / PR was achieved after prior therapy, but recurred within 6 months; 3) Recurrence after hematopoietic stem cell transplantation.
- Subjects must have at least one evaluable or measurable lesion per 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;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) : 0-1
- The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/ L, Hemoglobin(HB)≥ 80g/L, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, Serum creatinine (Scr) ≤1.5X ULN.
Who cannot join
- 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 within 4 weeks before the first administration of the study drugs;
- Subjects who received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days of the first administration of study drugs;
- Hypersensitivity to any study drug or its components;
Show all 15Show fewer
- Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
- 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.
- 9. Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x103 copy/mL; hepatitis C virus RNA high than 1x103 copy/mL) 10. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive) 11. Patients with other malignant tumors, except for effectively controlled non- melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors without treatment during the past 5 years. 12. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 13. Unsuitable subjects for this study determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
Tianjin, Please Select, 300020
About this study
Official title: Liposomal Mitoxantrone Hydrochloride, Gemcitabine, Vinorelbine With or Without Rituximab (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
This is a prospective, dose-escalation clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
Read the detailed description
This is a single-arm, single-center, dose-escalation clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, vinorelbine and/or rituximab (GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). Liposomal mitoxantrone hydrochloride will be given on day 1 at four different doses (16 mg/m2, 18 mg/m2, 20 mg/m2,22 mg/m2) and be combined with gemcitabine, vinorelbine and/or rituximab (rituximab only in CD20+ lymphoma). The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- Liposomal Mitoxantrone Hydrochloride dose level 1, Liposomal Mitoxantrone Hydrochloride dose level 2, Liposomal Mitoxantrone Hydrochloride dose level 3, Liposomal Mitoxantrone Hydrochloride dose level 4
- Keywords
- GVM±R, liposomal mitoxantrone hydrochloride
- 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.
Liposomal Mitoxantrone Hydrochloride dose level 1Drug
Liposomal Mitoxantrone Hydrochloride 16 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;
Liposomal Mitoxantrone Hydrochloride dose level 2Drug
Liposomal Mitoxantrone Hydrochloride 18 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;
Liposomal Mitoxantrone Hydrochloride dose level 3Drug
Liposomal Mitoxantrone Hydrochloride 20 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;
Liposomal Mitoxantrone Hydrochloride dose level 4Drug
Liposomal Mitoxantrone Hydrochloride 22 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;
| Study group | Role | What they receive |
|---|---|---|
| Liposomal mitoxantrone hydrochloride 16 mg/m^2 (with a caret included) | Experimental | Not described Receives: Drug: Liposomal Mitoxantrone Hydrochloride dose level 1 |
| Liposomal mitoxantrone hydrochloride 18 mg/m^2 (with a caret included) | Experimental | Not described Receives: Drug: Liposomal Mitoxantrone Hydrochloride dose level 2 |
| Liposomal mitoxantrone hydrochloride 20 mg/m^2 (with a caret included) | Experimental | Not described Receives: Drug: Liposomal Mitoxantrone Hydrochloride dose level 3 |
| Liposomal mitoxantrone hydrochloride 22 mg/m^2 (with a caret included) | Experimental | Not described Receives: Drug: Liposomal Mitoxantrone Hydrochloride dose level 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in GVM±R
Measured: Through the last patient complete his DLT observation, assessed up to 21 days
Secondary outcomes (5)
Dose limited toxicities (DLTs)
adverse events (AE) defined as DLT events per protocol
Measured: Through the last patient complete his DLT observation, assessed up to 21 days
The incidence rates of AE and SAE
AE or severe adverse events (SAE) occur since the first dose of therapy is given
Measured: up to 28 days after the last patient complete his study therapy
Objective response rate (ORR)
Response is assessed according to the lugano criteria
Measured: up to 2 years
Complete response rate (CRR)
Response is assessed according to the lugano criteria
Measured: : up to 2 years
progression-free survival（PFS）
From the date of the first dose of therapy is given until disease progression, death or last follow-up
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start15 May 2022
- Primary completion18 Dec 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 dose-escalation
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Wei Liu, Principal investigator, Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299164
- Sponsor's protocol ID
- IIT2022003
- Status last verified
- May 2025
- First submitted
- 10 Mar 2022
- Last updated
- 13 May 2025
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Mitoxantrone Hydrochloride, Gemcitabine, Vinorelbine With or Without Rituximab (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05299164
- Acronym / sponsor ID
- IIT2022003
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- GVM±R, liposomal mitoxantrone hydrochloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 15 May 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Mar 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, dose-escalation clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
Detailed description
This is a single-arm, single-center, dose-escalation clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, vinorelbine and/or rituximab (GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). Liposomal mitoxantrone hydrochloride will be given on day 1 at four different doses (16 mg/m2, 18 mg/m2, 20 mg/m2,22 mg/m2) and be combined with gemcitabine, vinorelbine and/or rituximab (rituximab only in CD20+ lymphoma). The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3+3 dose-escalation
| Arm | Type | Receives |
|---|---|---|
| Liposomal mitoxantrone hydrochloride 16 mg/m^2 (with a caret included) | Experimental | Drug: Liposomal Mitoxantrone Hydrochloride dose level 1 |
| Liposomal mitoxantrone hydrochloride 18 mg/m^2 (with a caret included) | Experimental | Drug: Liposomal Mitoxantrone Hydrochloride dose level 2 |
| Liposomal mitoxantrone hydrochloride 20 mg/m^2 (with a caret included) | Experimental | Drug: Liposomal Mitoxantrone Hydrochloride dose level 3 |
| Liposomal mitoxantrone hydrochloride 22 mg/m^2 (with a caret included) | Experimental | Drug: Liposomal Mitoxantrone Hydrochloride dose level 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects fully understand and voluntarily participate in this study and sign the informed consent
- Age ≥18, ≤70years, no gender limitation
- Expected survival ≥ 3 months;
- Histologically confirmed diagnosis of aggressive NHL.
- Subjects with relapsed or refractory NHL. Relapsed disease is defined as the disease relapsing after CR or PR, and the duration of prior response is more than 6 months. Refractory disease can be confirmed if any of the following conditions are met: 1) no PR or CR has been obtained after previous treatment; 2) CR / PR was achieved after prior therapy, but recurred within 6 months; 3) Recurrence after hematopoietic stem cell transplantation.
Key exclusion criteria (15 listed)
- The subject had previously received any of the following anti-tumor treatments:
- Hypersensitivity to any study drug or its components;
- Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
- Heart function and disease meet one of the following conditions:
- 9. Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x103 copy/mL; hepatitis C virus RNA high than 1x103 copy/mL) 10. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive) 11. Patients with other malignant tumors, except for effectively controlled non- melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors without treatment during the past 5 years. 12. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 13. Unsuitable subjects for this study determined by the investigator.
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 dose level 1Liposomal Mitoxantrone Hydrochloride 16 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma; | Drug | Liposomal mitoxantrone hydrochloride 16 mg/m^2 (with a caret included) |
| Liposomal Mitoxantrone Hydrochloride dose level 2Liposomal Mitoxantrone Hydrochloride 18 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma; | Drug | Liposomal mitoxantrone hydrochloride 18 mg/m^2 (with a caret included) |
| Liposomal Mitoxantrone Hydrochloride dose level 3Liposomal Mitoxantrone Hydrochloride 20 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma; | Drug | Liposomal mitoxantrone hydrochloride 20 mg/m^2 (with a caret included) |
| Liposomal Mitoxantrone Hydrochloride dose level 4Liposomal Mitoxantrone Hydrochloride 22 mg/m^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m^2) on day 1,8, every 3 weeks; Rituximab (375mg/m^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma; | Drug | Liposomal mitoxantrone hydrochloride 22 mg/m^2 (with a caret included) |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in GVM±R
5 secondary outcomes
Dose limited toxicities (DLTs)
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
The incidence rates of AE and SAE
Time frame: up to 28 days after the last patient complete his study therapy
Objective response rate (ORR)
Time frame: up to 2 years
Complete response rate (CRR)
Time frame: : up to 2 years
progression-free survival（PFS）
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- 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.
Wei Liu principal investigator
Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
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 Liposomal Mitoxantrone Hydrochloride dose level 1, Liposomal Mitoxantrone Hydrochloride dose level 2 and Liposomal Mitoxantrone Hydrochloride dose level 3 in people with Non Hodgkin Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China 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 8 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 (MTD) (time frame: Through the last patient complete his DLT observation, assessed up to 21 days). 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 13 May 2025.