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Peripheral T Cell LymphomaPhase 2NCT06244368

GVM±R in Patients With Relapsed or Refractory Aggressive NHL.

A Phase 2 study testing GVM±R regimen in people with Peripheral T Cell Lymphoma and Diffuse Large B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective 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 65 years
What is being tested?
GVM±R regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteChina
Study dates
17 Jan 2024to 30 Dec 2027
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18, ≤65 years.
  • Expected survival ≥ 3 months.
  • Subjects with aggressive NHL who have relapsed or proven refractory to at least one line of standard therapy or have achieved PR as the best response after a minimum of 4 cycles of therapy (patients with a Deauville score of 4 must have biopsy-proven residual disease). Relapse is defined as a disease response (PR/CR) to the last-line therapy with a duration of response exceeding 6 months. Refractory disease can be confirmed under any of the following conditions: 1) no partial or complete response to the last-line therapy; 2) the duration of complete or partial response to the last-line therapy is no longer than 6 months from the last dose of therapy; 3) Recurrence after hematopoietic stem cell transplantation.
  • Subjects must have at least one measurable lesion per lugano2014 criteria: for lymph node lesions, the long diameter should be > 1.5cm; For non-lymph node lesions, the long diameter should be > 1.0cm;
  • Eastern Cooperative Oncology Group (ECOG) : 0-2
  • Peripheral blood: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/L, Hemoglobin(HB)≥ 80g/L.(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×109/L, Platelet count (PLT) ≥50×109/L, Hemoglobin(HB)≥ 75g/L).
  • Liver and kidney function: Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN).(If the lymphoma involves the liver, TBIL≤3 X ULN.AST and ALT≤5 X ULN). For Pts diagnosed with Gilbert's disease, TBIL was enrolled if it was ≤3 X 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 (For other anthracyclines, 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 or 5 half-lives((whichever comes first) 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 before the first administration of study drugs;
  • Subjects who received chimeric antigen receptor T-cell (CAR-T) therapy.
Show all 22Show fewer
  • 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:
  • 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;
  • Left Ventricular Ejection Fractions (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.
  • Active hepatitis B and C infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than the Upper limit of normal(ULN); Hepatitis C virus antibody positive and hepatitis C virus RNA higher than the Upper limit of normal).
  • Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive).
  • 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.
  • Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures.
  • ≥ Grade 3 neuritis.
  • Active central nervous system (CNS) lymphoma;
  • Unsuitable subjects for this study determined by the investigator. -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Liu contact

022-23608461

liuwei@ihcams.ac.cn

China1 site, 1 recruiting

  • Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

    Tianjin, Tianjin Municipality, 300020

    Wei Liu, liuwei@ihcams.ac.cn

    liuwei@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome, Gemcitabine, Vinorelbine With or Without Anti-CD20 Monoclonal Antibody (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

This is a prospective 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, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with gemcitabine, vinorelbine and/or anti-CD20 monoclonal antibody(GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL).Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with gemcitabine, vinorelbine and/or rituximab (Pts with CD20-positive lymphomas are evaluated by the investigator on whether to combine rituximab or choose another CD20 monoclonal antibody).Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.

Being tested
GVM±R regimen
Keywords
aggressive non-Hodgkin's lymphoma (NHL), Mitoxantrone hydrochloride liposome, GVM±R
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GVM±R regimenDrug

    Mitoxantrone hydrochloride liposome (18 mg/m^2) on day 1； Gemcitabine (800 mg/m^2) on day 1,8； Vinorelbine (20mg/m^2) on day 1,8； Rituximab (375mg/m^2) on day 1;

    The regimen will be administered every 3 weeks, for a maximum of 6 cycles. The choice of CD20 monoclonal antibody will be determined by the attending physician.

Study groups in NCT06244368
Study groupRoleWhat they receive
GVM±RExperimentalPatients with relapsed or refractory aggressive NHL will undergo GVM±R therapy
Receives: Drug: GVM±R regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    Response is assessed according to the lugano criteria

    Measured: up to 2 years

Secondary outcomes (4)

  1. Complete Response Rate (CRR)

    Response is assessed according to the lugano criteria

    Measured: up to 2 years

  2. 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

  3. Overall survival (OS)

    From the date of inclusion to date of death, irrespective of cause

    Measured: up to 2 years

  4. Incidence of Treatment-Emergent Adverse Events

    The adverse events were evaluated by NCI-CTCAE 5.0 standard Hematologic and non-hematologic toxicity

    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.

  1. First posted6 Feb 2024
  2. Study start17 Jan 2024
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06244368
Sponsor's protocol ID
IIT2023065
Status last verified
May 2025
First submitted
28 Jan 2024
Last updated
14 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GVM±R regimen in people with Peripheral T Cell Lymphoma and Diffuse Large B-cell 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 7 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 14 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 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?

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?

Contact Wei Liu (022-23608461, liuwei@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06244368.

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 14 May 2025.

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