Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With... | Not Recruiting
Study of Lenalidomide to Evaluate S... | Not Recruiting
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Trial Source

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Medical Conditions
  • Diffuse Large B-cell Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01197560
Primary Trial ID Number

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Summary
The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.
Research Details
  • This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. DLBCL is just one type of lymphoma. Within DLBCL there are two different subtypes called Germinal Center B-cell (GCB) and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both.

    This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs.

    On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013 data cutoff date. According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Additionally, a suitable assay for the selection of participants for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not open Stage 2.
Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Lenalidomide, Drug : Gemcitabine, Drug : Oxaliplatin, Drug : Rituximab, Drug : Etoposide

Study Arm Groups : Lenalidomide, Investigators Choice, Investigators Choice, Investigators Choice, Investigators Choice

Intervention Type
See Interventions above
Primary Outcome Measures
    Stage 1: Percentage of Participants With an Overall Response Rate (ORR) According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999.; From Sept 2010 to the data cut-off of 4 July 2013; when all participants had reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment). Median follow-up time was 6.7 and 4.7 months in each arm respectively; Stage 2: Progression-free Survival for Diffuse Large B-Cell Lymphoma (DLBCL) Participants; null
Secondary Outcome Measures
    Stage 2: Complete Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants; null; Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants; null; Stage 2: Duration of Overall Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants; Approximately 3.5 years; Stage 2: Overall Survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) Participants; null; Stage 2: Duration of Complete Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants; null; Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Patients With a Duration of Response Lasting ≥ 16 Weeks; null; Stage 2: Time to Progression for Diffuse Large B-Cell Lymphoma (DLBCL) Participants; null; Stage 2: Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) Patients; null
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).

    - Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.

    - Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).

    - Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

    Exclusion Criteria:

    - Diagnosis of lymphoma histologies other than DLBCL.

    - History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.

    - Eligible for autologous stem cell transplant.

    - Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)

    - Neuropathy grade 4.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Royal Devon and Exeter Hospital
Exeter
England
EX2 5DW
Plymouth
PL6 8DH
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Cancer Research UK Centre/Southhampton General Hospital
Southampton
SO16 6YD
Royal Mardsen Hospital - Fulham (Satellite Site)
London
SW3 6U
Royal Mardsen NHS Foundation Trust
SM2 SPT
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Austria, Czech Republic, France, Italy, Spain, Sweden, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CC-5013-DLC-001
Sponsor(s)
Celgene Corporation
Key Dates

Recruitment Start Date

Sep 2010

Recruitment End Date

Jul 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

29 Jul 2010

Date updated in source

24 Nov 2015