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Not yet recruitingNCT06921044Updated Apr 10, 2025

A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL

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

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
80 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma

Keywords

  • Diffuse large B-cell lymphoma,
  • Mitoxantrone Hydrochloride liposomal
03

In context

Lymphoma, Large B-Cell, Diffuse

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 →

Lead sponsor

This is the only study on the registry with Xiaohui He as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 80 years
  2. The histopathological diagnosis was diffuse large B-cell lymphoma, and immunohistochemistry was positive for CD20
  3. Previously untreated disease
  4. Ann Arbor stage I-IV disease
  5. According to Lugano2014 criteria, there must be at least one matching evaluable or measurable lesion: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be > 1.0cm in length;
  6. ECOG score 0-4(ECOG score 0-2 after pre-treatment and before R-mini-MCOP regimen)
  7. Bone marrow function: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80g/L (neutrophil count ≥1.0×109/L, platelet count ≥50×109/L, hemoglobin ≥75 g/L in patients with bone marrow involvement);
  8. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion;
  9. Have the swallowing power
  10. Life expectancy > 3 months
  11. Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF) -

Exclusion criteria

Exclusion Criteria:

  1. Previous systemic antitumor therapy (except pre-therapy used before the first cycle of R-CMOP);
  2. Metastatic diffuse large B-cell lymphoma;
  3. Known central nervous system lymphoma
  4. Hypersensitivity to any investigational drug or its ingredients;
  5. Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
  6. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x103 copies /mL; More than 1x103 copies /mL of HCV RNA);
  7. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
  8. Other serious comorbidities, intolerance to this protocol or inappropriate participation in this study (judged by the investigator)
  9. Previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years);
  10. Inability to swallow the drug or any significant removal of the small intestine that may prevent full absorption of the drug;
  11. Situations in which other investigators have determined that participation in this study is not appropriate.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    R-mini-MCOP

    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

Interventions

  • DrugR-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

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Feb 25, 2025
First posted
Apr 10, 2025
StartEst.
Apr 16, 2025
Primary completionEst.
Feb 1, 2026
CompletionEst.
Mar 1, 2027
Last update
Apr 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06921044
Lead sponsor
Xiaohui He
Responsible party
Xiaohui He (Chief physician,Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Sponsor-investigator
First posted
Apr 10, 2025
Start date
Apr 16, 2025 (estimated)
Primary completion
Feb 1, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Apr 10, 2025

Study contacts

Sheng Yang
Contact
medart@126.com
13683260156

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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