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

Last updated: May 12, 2025
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Hematologic Cancer

Non-hodgkin's Lymphoma

Treatment

GVM±R regimen

Clinical Study ID

NCT06244368
IIT2023065
  • Ages 18-65
  • All Genders

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).

Eligibility Criteria

Inclusion

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 oneline 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-provenresidual disease). Relapse is defined as a disease response (PR/CR) to the last-linetherapy with a duration of response exceeding 6 months. Refractory disease can beconfirmed under any of the following conditions: 1) no partial or complete responseto the last-line therapy; 2) the duration of complete or partial response to thelast-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 lymphnode lesions, the long diameter should be > 1.5cm; For non-lymph node lesions, thelong 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 bonemarrow 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 involvesthe liver, TBIL≤3 X ULN.AST and ALT≤5 X ULN). For Pts diagnosed with Gilbert'sdisease, TBIL was enrolled if it was ≤3 X ULN.-

Exclusion

Exclusion Criteria:

  1. The subject had previously received any of the following anti-tumor treatments:

  2. Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;

  3. Previously received doxorubicin or other anthracycline treatment, and the totalcumulative dose of doxorubicin was more than 360 mg/m2 (For otheranthracyclines, 1 mg doxorubicin equivalent to 2 mg epirubicin);

  4. Subjects who received anti-tumor treatment (including chemotherapy, targetedtherapy, 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 administrationof the study drugs;

  5. Subjects who received autologous hematopoietic stem cell transplantation orallogeneic hematopoietic stem cell transplantation within 100 days before thefirst administration of study drugs;

  6. Subjects who received chimeric antigen receptor T-cell (CAR-T) therapy.

  7. Hypersensitivity to any study drug or its components.

  8. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension,diabetes, etc.)

  9. Heart function and disease meet one of the following conditions:

  10. Long QTc syndrome or QTc interval > 480 ms;

  11. Complete left bundle branch block, grade II or III atrioventricular block;

  12. Serious and uncontrolled arrhythmias requiring drug treatment;

  13. New York Heart Association grade ≥ III;

  14. Left Ventricular Ejection Fractions (LVEF)< 50%;

  15. A history of myocardial infarction, unstable angina pectoris, severe unstableventricular arrhythmia or any other arrhythmia requiring treatment, a historyof clinically serious pericardial disease, or ECG evidence of acute ischemia oractive conduction system abnormalities within 6 months before recruitment.

  16. Active hepatitis B and C infection (defined as hepatitis B virus surface antigenpositive 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 Upperlimit of normal).

  17. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive).

  18. Patients with other malignant tumors, except for effectively controlled non-melanomaskin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors withouttreatment during the past 5 years.

  19. Pregnant and lactating women and patients of childbearing age who are unwilling totake contraceptive measures.

  20. ≥ Grade 3 neuritis.

  21. Active central nervous system (CNS) lymphoma;

  22. Unsuitable subjects for this study determined by the investigator. -

Study Design

Total Participants: 115
Treatment Group(s): 1
Primary Treatment: GVM±R regimen
Phase: 2
Study Start date:
January 17, 2024
Estimated Completion Date:
December 30, 2027

Study 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.

Connect with a study center

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

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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