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.

Diffuse Large B-cell Lymphoma Clinical Trial

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05990985
• Other study ID #: CSPC-DED-DLBCL-K10
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: August 2023
• Source: The First Hospital of Jilin University
• Contact: Ou Bai, PHD
• Phone: 13039046656
• Email: oubai16[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent

2. Age=18 years old

3. International Prognostic Index (IPI)>2

4. Expected survival = 3 months

5. 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

6. Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment

7. 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

8. ECOG Performance Status: 0-1

9. 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)

10. 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:

1. Hypersensitivity to any study drug or its components

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

3. 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%

4. 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)

5. Human immunodeficiency virus (HIV) infection (HIV antibody positive)

6. 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)

7. Subjects suffering from primary or secondary central nervous system (CNS) lymphoma

8. pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures

9. Mental patients or those who cannot obtain informed consent

10. Unsuitable subjects for this study determined by the investigator.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Mitoxantrone hydrochloride liposome injection
Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
• RiTUXimab Injection
RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
• Cyclophosphamid
Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
• Vincristine
Vincristine (1.4 mg/m^2,maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
• Prednisolone
Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.

Locations

Country	Name	City	State
China	The First Bethune Hospital of Jilin University	Changchun	Jilin

Sponsors (2)

Lead Sponsor	Collaborator
The First Hospital of Jilin University	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	To evaluate the efficacy of anti-tumor	At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
Secondary	Complete response rate (CRR)	To evaluate the efficacy of anti-tumor	At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)
Secondary	Duration of Response (DOR)	To evaluate the efficacy of anti-tumor	CR or PR up to data cut-off (up to approximately 2 years)
Secondary	Progression-free survival (PFS)	To evaluate the efficacy of anti-tumor	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Overall survival (OS)	To evaluate the efficacy of anti-tumor	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Treatment emergent adverse events (TEAEs)	The incidence and severity of adverse events assessed by CTCAE v5.0	The first dose up to 21 or 28 days after the last dose