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NCT Number: NCT05990985

The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.

A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location contact

Ou Bai, PHD

CONTACT

[email protected]

13039046656

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects fully understand and voluntarily participate in this study and sign informed consent
  • Age≥18 years old
  • International Prognostic Index (IPI)>2
  • Expected survival ≥ 3 months
  • DLBCL initially diagnosed by histopathology meets the following subtypes according to the 2016 WHO classification: (1) Germinal center B-cell-like (GCB) subtype; (2) Non-germinal center B-cell-like (non-GCB) subtype
  • Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment
  • At least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: Nodal lesion: Greatest transverse diameter>1.5cm; Extra-nodal lesion: Greatest transverse diameter>1.0cm
  • ECOG Performance Status: 0-1
  • Bone marrow function: Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥75×10^9/L, Hemoglobin ≥ 80g/L (Patients with bone marrow involvement were judged by the investigator to enter the group)
  • Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN (≤ 3×ULN for subjects with liver metastases).

Exclusion criteria

  • 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: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Serious and uncontrolled arrhythmias requiring drug treatment, uncontrolled angina with poor drug control and myocardial infarction within 6 months before enrollment; (3) New York Heart Association grade III~IV; (4) Cardiac ejection fraction (LVEF)< 45%
  • Hepatitis B and hepatitis C active infection (HBV DNA above upper limit of normal; HCV antibody positive and HCV RNA above upper limit of normal)
  • Human immunodeficiency virus (HIV) infection (HIV antibody positive)
  • Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past five years)
  • Subjects suffering from primary or secondary central nervous system (CNS) lymphoma
  • pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures
  • Mental patients or those who cannot obtain informed consent
  • Unsuitable subjects for this study determined by the investigator.

Treatment and study plan

Mitoxantrone hydrochloride liposome injection

Drug

Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.

Other names: duoenda

RiTUXimab Injection

Drug

RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.

Other names: lituoxidankang

Cyclophosphamid

Drug

Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.

Other names: huanlinxianan

Vincristine

Drug

Vincristine (1.4 mg/m^2,maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.

Other names: changchunxinjian

Prednisolone

Drug

Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.

Other names: ponisong

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)

    To evaluate the efficacy of anti-tumor

Secondary outcomes

  1. Complete response rate (CRR)

    Time frame: At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)

    To evaluate the efficacy of anti-tumor

  2. Duration of Response (DOR)

    Time frame: CR or PR up to data cut-off (up to approximately 2 years)

    To evaluate the efficacy of anti-tumor

  3. Progression-free survival (PFS)

    Time frame: Baseline up to data cut-off (up to approximately 2 years)

    To evaluate the efficacy of anti-tumor

  4. Overall survival (OS)

    Time frame: Baseline up to data cut-off (up to approximately 2 years)

    To evaluate the efficacy of anti-tumor

  5. Treatment emergent adverse events (TEAEs)

    Time frame: The first dose up to 21 or 28 days after the last dose

    The incidence and severity of adverse events assessed by CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Ou Bai, PHD

CONTACT

[email protected]

13039046656

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

Registry information

Official study title

A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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