AZA Combined with R-GemOx for Elderly DLBCL Patients (Dragon)

Army Medical University of People's Liberation Army

Status and phase: Not yet enrolling; Phase 2

Conditions: DLBCL - Diffuse Large B Cell Lymphoma

Treatments: Drug: R-GemOx; Drug: azacytidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06778902

2024-322

ZXYZZKY07 (Other Grant/Funding Number)

Details and patient eligibility

About

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly diffuse large B-cell lymphoma (DLBCL) patients.

Full description

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of AZA in combination with R-GemOx for untreated elderly DLBCL patients.

The induction phase consisted of 8 cycles of AZA in combination with R-GemOx for a total of 8 treatment cycles. The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.

The primary endpoint is the overall response rate (ORR).Secondary efficacy measures included CR and PR,SD, progression-free survival (PFS) and overall survival (OS).

Enrollment: 80 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Aged ≥60 years, both male and female.
3. Pathologically confirmed DLBCL
4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
5. No previous chemotherapy or radiotherapy for DLBCL has been received.
6. Expected survival ≥3 months.

Key Exclusion Criteria:

1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients have contraindications to any drug in the combined treatment.
4. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
5. Mentally ill persons or persons unable to obtain informed consent.
6. The investigators think that the patient is not suitable for the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

AZA+GemOx

Experimental group

Description:

Elderly DLBCL patients will receive AZA in combination with R-GemOx for a total of 8 treatment cycles (3 weeks per cycle). The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.

Treatment:

Drug: azacytidine

Drug: R-GemOx