Mitoxantrone Hydrochloride Liposome Combined With Rituximab and Lenalidomide (M+R2) in Patients With Relapsed and Refractory Diffuse Large B-Cell Lymphoma

Sponsor
Jianfeng Zhou
Study ID
NCT05575973
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone Hydrochloride Liposome — DRUG
    Drug: Mitoxantrone hydrochloride liposome (20 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
  • Rituximab — DRUG
    Drug: Rituximab (375 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
  • Lenalidomide — DRUG
    Drug: Lenalidomide (25 mg) will be taken orally from day 1 to day 8 of each 28-day cycle.

Study Details

To evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with rituximab and lenalidomide in the treatment of relapsed and refractory diffuse large B-cell lymphoma (DLBCL).

Key Dates

Start date
Oct 10, 2022
Status verified
Oct 2022
Primary completion
Jul 31, 2025
Completion
Oct 31, 2025

Study Design

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

Arms

  • Experimental: mitoxantrone hydrochloride liposome
    Patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) will receive sequentially mitoxantrone hydrochloride liposome in combination with rituximab and lenalidomide for up to 6 cycles (28 days per cycle).

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: through study completion, an average of 2 year ]

Central Contacts

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