A Phase II Study of the FIL on Elderly Frail Patients With DLBCL

Conditions

• Diffuse Large B-cells Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab-Dexamethasone-Lenalidomide — DRUG
  1. st CYCLE: Rituximab 375 mg/m2 i.v. on days 1,8,15; Dexamethasone 5 mg p.o. on days 1,8,15,22; Lenalidomide 15 mg/day p.o. day 2-22 2. nd-4th CYCLE: Rituximab 375 mg/m2 i.v. on day 1; Lenalidomide 20 mg/day p.o. from day 2 to day 22 At the end of 4th CYCLE disease restaging: - if ≥ PR continues with the 5th and 6th cycle: Rituximab 375 mg/m2 i.v. on day 1, Lenalidomide 20 mg /day p.o. day 2-22 * if \<PR stops the treatment, only follow-up At the end of the 6th CYCLE disease restaging: - if ≥ PR continues with beyond the 6th cycle with Lenalidomide 10mg dd1-21q28 until cycle 12th * if \<PR stops the treatment, only follow-up Then, accordingly response rate after the sixth cycle assessment(≥ PR) lenalidomide will be continued at 10 mg dd1-21q28 until 12th cycle or unacceptable toxicity.

Study Details

A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.

Key Dates

Start date

Sep 30, 2016

Status verified

Dec 2022

Primary completion

Sep 22, 2020

Completion

Nov 24, 2022

Study Design

Enrollment

68 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1 arm for all patient: Ritux-Dexame-Lena
  Rituximab-Dexamethasone-Lenalidomide

Primary Outcome Measure

ORR [ Time Frame: 48 months ]