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

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

Study Overview

• Status: Unknown
• Conditions: Diffuse Large B-Cell Lymphoma Refractory
• Intervention / Treatment: Drug: Lenalidomide; Drug: Carboplatin; Drug: Ifosfamide; Drug: Etoposide

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Shanghai Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-ICE; Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4	Drug: Lenalidomide; Drug: Carboplatin; Drug: Ifosfamide; Drug: Etoposide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete response rate	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Weili Zhao, MD, PhD, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Etoposide; Lenalidomide; Ifosfamide
• Other Study ID Numbers: L-ICE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO