Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

Diffuse Large B-Cell Lymphoma Refractory Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03367143
• Other study ID #: L-ICE
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma Refractory
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Lenalidomide

• Ifosfamide

• Carboplatin

• Etoposide

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		12 weeks
Secondary	Progression free survival rate		1 year
Secondary	Overall survival rate		1 year
Secondary	Overall response rate		12 weeks
Secondary	Safety as assessed using CTCAE v4.0		1 year