Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

March 9, 2020 updated by: Zhao Weili, Ruijin Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Complete response rate
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival rate
Time Frame: 1 year
1 year
Progression free survival rate
Time Frame: 1 year
1 year
Overall response rate
Time Frame: 12 weeks
12 weeks
Safety as assessed using CTCAE v4.0
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weili Zhao, MD, PhD, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L-ICE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large B-Cell Lymphoma Refractory

  • NCT06784726
    Recruiting
    Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T
    Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent High Grade B-Cell Lymphoma | Refractory High Grade B-Cell Lymphoma | Recurrent Grade 3b Follicular Lymphoma | Refractory Grade 3b Follicular Lymphoma | Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma | Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
  • NCT06834373
    Recruiting
    Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
    Recurrent Transformed Non-Hodgkin Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma | Refractory Aggressive B-Cell Non-Hodgkin Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type | Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type | Recurrent Grade 3b Follicular Lymphoma | Refractory Grade 3b Follicular Lymphoma | Refractory Transformed Non-Hodgkin Lymphoma
  • NCT05075603
    Completed
    Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy
    Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory High Grade B-Cell Lymphoma | Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-cell Lymphoma
  • NCT05507541
    Active, not recruiting
    TTI-622 in Combination With Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | Recurrent High Grade B-Cell Lymphoma | Refractory High Grade B-Cell Lymphoma
  • NCT05359211
    Active, not recruiting
    NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
    Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent Grade 3b Follicular Lymphoma | Refractory Grade 3b Follicular Lymphoma | Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma | Recurrent Primary Mediastinal Large B-Cell Lymphoma | Refractory Primary Mediastinal Large B-Cell Lymphoma
  • NCT05228249
    Withdrawn
    Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma
    Recurrent Diffuse Large B-Cell Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements | Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma | Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
  • NCT07188558
    Recruiting
    A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy (PiNACLE-H2H)
    Lymphoma, B-Cell | Diffuse Large B Cell Lymphoma Refractory | Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Large B-cell Lymphoma | Diffuse Large B Cell Lymphoma Relapsed | Relapsed Non-Hodgkin Lymphoma | Diffuse Large B Cell Lymphoma (DLBCL) | Non-Hodgkin Lymphoma Refractory/ Relapsed
  • NCT07365306
    Recruiting
    Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
    Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified | Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified | Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma | Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma | Recurrent Primary Mediastinal Large B-Cell Lymphoma | Refractory Primary Mediastinal Large B-Cell Lymphoma
  • NCT04659434
    Not yet recruiting
    Sintilimab Plus R-GemOx as Second-line Salvage Therapy in Patients With R/R DLBCL
    Diffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell Lymphoma
  • NCT06209619
    Recruiting
    CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma
    B-Cell Non-Hodgkin Lymphoma-Recurrent | Diffuse Large B-Cell Lymphoma-Recurrent | Follicular Lymphoma-Recurrent | High Grade B-Cell Lymphoma-Recurrent | Primary Mediastinal Large B-Cell Lymphoma-Recurrent | Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent | B-Cell Non-Hodgkin Lymphoma-Refractory | Diffuse Large B-Cell Lymphoma-Refractory | Follicular Lymphoma-Refractory | High Grade B-Cell Lymphoma-Refractory

Clinical Trials on Lenalidomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings