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RecruitingNCT06244368Updated May 14, 2025

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

A Phase 2 interventional study of GVM±R regimen in Peripheral T Cell Lymphoma and Diffuse Large B-cell Lymphoma, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
115
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Peripheral T Cell Lymphoma
  • Diffuse Large B-cell Lymphoma

Keywords

  • aggressive non-Hodgkin's lymphoma (NHL)
  • Mitoxantrone hydrochloride liposome
  • GVM±R
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18, ≤65 years.
  2. Expected survival ≥ 3 months.
  3. 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.
  4. 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;
  5. Eastern Cooperative Oncology Group (ECOG) : 0-2
  6. 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).
  7. 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.-

Exclusion criteria

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 (For other anthracyclines, 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 within 4 weeks or 5 half-lives((whichever comes first) before the first administration of the study drugs;
    4. Subjects who received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days before the first administration of study drugs;
    5. Subjects who received chimeric antigen receptor T-cell (CAR-T) therapy.
  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. Left Ventricular Ejection Fractions (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. 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).
  6. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive).
  7. 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.
  8. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures.
  9. ≥ Grade 3 neuritis.
  10. Active central nervous system (CNS) lymphoma;
  11. Unsuitable subjects for this study determined by the investigator. -
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants (estimated)

Study arms

  • Experimental
    GVM±R

    Patients with relapsed or refractory aggressive NHL will undergo GVM±R therapy

    Drug: GVM±R regimen

Interventions

  • DrugGVM±R regimen

    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.

05

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

    Response is assessed according to the lugano criteria

    Time frame: up to 2 years

Secondary outcomes

  1. Complete Response Rate (CRR)

    Response is assessed according to the lugano criteria

    Time frame: 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

    Time frame: up to 2 years

  3. Overall survival (OS)

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

    Time frame: 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

    Time frame: up to 2 years

06

Study locations

1 of 1 sites recruiting
  • Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
    Tianjin, Tianjin 300020, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06244368
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
First Hospital of China Medical University, Hebei Medical University Fourth Hospital, Chengdu Shangjin Nanfu Hospital, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Xuanwu Hospital, Beijing, The Affiliated Ganzhou Hospital of Nanchang University, Beijing Tongren Hospital, The First Affiliated Hospital of Dalian Medical University, The First Hospital of Jilin University, People's Hospital of Zhengzhou University, The First Affiliated Hospital of Bengbu Medical University, The Second Affiliated Hospital of Kunming Medical University, The First Affiliated Hospital of Nanchang University, The Second Affiliated Hospital of Harbin Medical University, Shengjing Hospital, Peking University Third Hospital, First Affiliated Hospital of Harbin Medical University, China-Japan Friendship Hospital
Responsible party
Sponsor
First posted
Feb 6, 2024
Start date
Jan 17, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
May 14, 2025

Study contacts

Wei Liu
Contact
liuwei@ihcams.ac.cn
022-23608461
Wei Liu
principal investigator · Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
Xiaojing Yan
principal investigator · First Hospital of China Medical University
HaiSheng、Chen Liu 、Huang
principal investigator · Hebei Medical University Fourth Hospital
Yongqian Jia
principal investigator · Chengdu Shangjin Nanfu Hospital
Yunhong Huang
principal investigator · Affiliated Cancer Hospital & Institute of Guizhou Medical University
Xiaobo Wang
principal investigator · The Second Affiliated Hospital of Dalian Medical University
Wanling Sun
principal investigator · Xuanwu Hospital, Beijing
Mingxing Zhong
principal investigator · The Affiliated Ganzhou Hospital of Nanchang University
Liang Wang
principal investigator · Beijing Tongren Hospital
Xiuli Sun
principal investigator · The First Affiliated Hospital of Dalian Medical University
Ou Bai
principal investigator · The First Hospital of Jilin University
Shuxia Guo
principal investigator · People's Hospital of Zhengzhou University
Yanli Yang
principal investigator · The First Affiliated Hospital of Bengbu Medical University
Zeping Zhou
principal investigator · The Second Affiliated Hospital of Kunming Medical University
Fei Li
principal investigator · The First Affiliated Hospital of Nanchang University
Aichun Liu
principal investigator · The Second Affiliated Hospital of Harbin Medical University
Aijun Liao
principal investigator · Shengjing Hospital
Hongmei Jing
principal investigator · Peking University Third Hospital
Shuye Wang
principal investigator · First Affiliated Hospital of Harbin Medical University
Zhenling Li
principal investigator · China-Japan Friendship Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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