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This study was a multicenter, open, randomized controlled, phase II clinical study. Is expected in 70 cases of late relapsed diffuse large B cell lymphoma, were randomly assigned to receive mitoxantrone liposomes modified R - MINE plan or R - GemOx treatment. Each cycle was 3 weeks (21 days) for a total of 4 cycles. Subjects assigned to each signed informed consent to screening, screening, in the center of the study determined in accordance with the order signed informed consent. Before the start of the trial, the number of random seeds was set by the statistician, and the block randomization method was used to generate the subject random table using R 4.3.3 (or above). The random ratio between the modified R-mine group and the R-Gemox group was 1:1. After the investigator determined that the subjects were screened successfully, the subjects were randomly numbered according to the order in which the eligible subjects were screened successfully. The intervention was performed by the principal investigator or by someone designated by the principal investigator. Study includes screening period (the first 28 days), treatment period (plan 4 cycles, treatment after 2 cycles enhanced CT/MRI or PET - CT mid-term efficacy, PET - CT curative effect evaluation) after treatment, follow-up (follow-up curative effect, safety and survival follow-up follow-up). Participants provided written informed consent and underwent baseline examinations during the screening period. Participants who met the inclusion criteria and none of the exclusion criteria entered the treatment period. All the study participants completed protocol-specified examinations during the course of treatment to observe efficacy and safety. The end of the treatment period was followed by the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified R-MINE | Experimental |
| |
| R-GemOx | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab+Ifosfamide+Mesna+Mitoxantrone hydrochloride liposome+Etoposide | Drug | Rituximab 375 mg/m^2, d0; Ifosfamide 1.33 g/m^2, d1-3 (equal dose of mesna rescue); Mitoxantrone hydrochloride liposome 12mg/m^2, d1; Etoposide 65 mg/m^2, d1-3; Every 21 days as one cycle, and 4 cycles were planned. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Response is assessed according to the lugano criteria. | every 2 cycles, up to 4 cycles (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Response is assessed according to the lugano criteria. | every 2 cycles, up to 4 cycles (each cycle is 21 days) |
| Duration of response (DoR) | The time from the first assessment of CR or PR for the tumor to the first assessment of recurrence or PD or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
Previous history of antitumor therapy meeting any of the following conditions:
Hypersensitivity to any study drug or its components;
Uncontrolled systemic diseases (e.g., progressive infections, uncontrolled hypertension, diabetes, etc.);
Cardiac function and diseases meeting any of the following conditions:
Active hepatitis B or C infection (hepatitis B surface antigen positive with HBV DNA >1×10³ copies/mL; HCV RNA >1×10³ copies/mL);
Human immunodeficiency virus (HIV) infection (HIV antibody positive);
History or concurrent presence of other malignancies (except for effectively controlled non-melanoma skin basal cell carcinoma, in situ carcinoma of the breast/cervix, and other malignancies effectively controlled without treatment in the past five years);
Presence of primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at enrollment;
Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
Requirement for systemic corticosteroid therapy or other immunosuppressive therapy due to a medical condition within 14 days before the start of study treatment [topical use (ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption) is permitted; short-term (≤7 days) corticosteroid use for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to contact allergens) is permitted];
Other conditions deemed by the investigator to be unsuitable for participation in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Xu | Contact | 025-68306034 | xuwei10000@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Xu | The first Affiliated Hospital of Nanjing Medical University(JiangSu Province Hospital) | Principal Investigator |
| Jinhua Liang | The first Affiliated Hospital of Nanjing Medical University(JiangSu Province Hospital) |
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|
| Rituximab+Gemcitabine+Oxaliplatin | Drug | Rituximab 375 mg/m^2, d0; Gemcitabine 1000 mg/m^2, d1; Oxaliplatin 100 mg/m^2, d1; Every 21 days as one cycle, and 4 cycles were planned. |
|
| 2 years |
| Progression-free survival (PFS) | PFS was defined as the time between randomization and the first date of progression, relapse, or death from any cause. | 2 years |
| Overall survival (OS) | From the date of randomization to date of death, irrespective of cause. | 2 years |
| Adverse events (AEs) | The incidence, type, and severity of adverse events (graded according to CTCAE v5.0), and their relationship to the study treatment. | From the start of treatment to 28 days after the end of treatment. |
| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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