R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06594640
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone Hydrochloride Liposome — DRUG
    assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2
  • Rituximab (R) — DRUG
    375mg/m2, D2
  • Cyclophosphamide (CTX) — DRUG
    750mg/m2, D2
  • Vincristin — DRUG
    1.2mg/m2, maximum 2mg， D2
  • Prednisolone — DRUG
    60mg/m2, D2-6

Study Details

This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma

Key Dates

Start date
May 30, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Jul 30, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-CMOP
    R-CMOP regimen includes rituximab (R), cyclophosphamide (C), mitoxantrone hydrochloride liposome injection (M), vincristine (O), and prednisone (P). The regimen will be administered every 3 weeks, for a maximum of 6 cycles.

Primary Outcome Measure

Phase I:Maximum tolerated dose (MTD) [ Time Frame: Through the last patient complete his DLT observation, assessed up to 21 days ]

Central Contacts

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