Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT04622579
Phase
PHASE2
Status
Unknown

Conditions

  • Age Over 80 Years
  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

Study Details

About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.

Key Dates

Start date
Oct 23, 2020
Status verified
Nov 2020
Primary completion
Dec 31, 2022
Completion
Mar 31, 2023

Study Design

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

Arms

  • Experimental: lenalidomide combined with rituximab
    Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.

Primary Outcome Measure

ORR [ Time Frame: 24 months ]

Central Contacts

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