Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03367143

Enrollment

Registered

2017-12-08

Start date

2016-12-31

Completion date

2020-12-31

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma Refractory

Brief summary

This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.

Interventions

DRUGLenalidomide

DRUGIfosfamide

DRUGCarboplatin

DRUGEtoposide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment. 2. No history of stem cell transplantation. 3. Age between 16-75. 4. ECOG\<3. 5. At least 1 measurable tumor mass. 6. Minimum life expectancy of 3 months. 7. Written informed consent. 8. No history of using Lenalidomide, ifosfamide, carboplatin and etoposide. 9. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.

Exclusion criteria

1. Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. 2. Clinically significant active infection. 3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. 4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. 5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. 6. Patients who are pregnant or breast-feeding. 7. HIV infection.

Design outcomes

Primary

Measure	Time frame
Complete response rate	12 weeks

Secondary

Measure	Time frame
Progression free survival rate	1 year
Overall survival rate	1 year
Overall response rate	12 weeks
Safety as assessed using CTCAE v4.0	1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026