A Phase 2 interventional study of R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone in Diffuse Large B-Cell Lymphoma, sponsored by Xiaohui He. Not yet recruiting. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Xiaohui He · Phase 2, Interventional, and Treatment
Research purpose: To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design: Single-arm, multicenter, prospective study
1,432 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 359 are open to participants now.
This study's planned enrollment of 33 is below the median of 47 across 1,214 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →This is the only study on the registry with Xiaohui He as lead sponsor.
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Exclusion Criteria:
Rituximab :375 mg/m2,ivgtt,d0; Mitoxantrone Liposome : The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2,ivgtt,d1; Vincristine :1mg,ivgtt,d1; Prednisone:40 mg/m2,po.,d1-5; Q3W(Every 3 Weeks)
Drug: R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone
Rituximab :375 mg/m2,ivgtt,d0; Mitoxantrone Liposome : The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2,ivgtt,d1; Vincristine :1mg(,ivgtt,d1; Prednisone:40 mg/m2,po.,d1-5; Q3W
Complete response rate (CRR)
Complete response rate at the end of induction
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Overall Response (CR+PR) Rate (ORR)
Overall Response (CR+PR) rate at the end of induction
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Duration of response (DOR)
Time frame: From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date)
Progression-free survival (PFS)
Time frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months)
Overall Survival (OS)
Time frame: Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months)
Event Free Survival (EFS)
Time frame: From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months)
No study locations are listed for this record.
Start is estimated for Apr 2025; primary completion for Feb 2026, 9 months later.
Of 198 non-industry phase 2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 97. This study's planned 9 months is below that.
Counting every sponsor, half of 249 studies reached it within 53 months; a quarter within 35 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Lymphoma, Large B-Cell, Diffuse →