Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

NCT03367143 | Unknown Phase 2 DMC

• 1 other identifier: L-ICE
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B-Cell Lymphoma Refractory

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  12 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

L-ICE

EXPERIMENTAL

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: Ifosfamide; Drug: Carboplatin; Drug: Etoposide

Interventions

Lenalidomide DRUG

L-ICE

Ifosfamide DRUG

L-ICE

Carboplatin DRUG

L-ICE

Etoposide DRUG

L-ICE

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No history of stem cell transplantation.
• Age between 16-75.
• ECOG\<3.
• At least 1 measurable tumor mass.
• Minimum life expectancy of 3 months.
• Written informed consent.
• No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Interventions

Lenalidomide; Ifosfamide; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Oxazines; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Weili Zhao, MD, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: December 8, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)