Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
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ClinicalTrials.gov Identifier: NCT01197560 |
Recruitment Status
:
Active, not recruiting
First Posted
: September 9, 2010
Results First Posted
: August 20, 2014
Last Update Posted
: January 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diffuse Large B-cell Lymphoma | Drug: Lenalidomide Drug: Gemcitabine Drug: Oxaliplatin Drug: Rituximab Drug: Etoposide | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 111 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | September 1, 2010 |
Actual Primary Completion Date : | July 4, 2013 |
Estimated Study Completion Date : | March 4, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Lenalidomide |
Drug: Lenalidomide
Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
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Active Comparator: Investigators Choice
One of the following: Lenalidomide, Gemcitabine, Oxaliplatin, Rituximab, or Etoposide |
Drug: Gemcitabine
Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m2 IV days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m2 IV days 1 and 15 every 28 days for 6 Cycles
Drug: Oxaliplatin
Suggested starting dose and regimen for Oxaliplatin is 100 mg/m2 IV day 1 for 21 days for 6 Cycles
Drug: Rituximab
Suggested starting dose for Rituximab is 375 mg/m2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
Drug: Etoposide
Suggested starting doses for Etoposide are: 100 mg/m2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-10 every 28 days for 6 Cycles |
- 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. [ Time Frame: 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 ]
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL as evaluated by the Independent Response Adjudication Committee (IRAC).
Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.
CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.
Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes
- Stage 2: Progression-free Survival for Diffuse Large B-Cell Lymphoma (DLBCL) ParticipantsNumber of participants who survive without progressing based on the International Working Group Response Criteria [IWG].
- Stage 2: Complete Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Complete Response Rate (CR + CRu rate) was to be calculated as the proportion of participants achieving a CR or CRu using 1999 IWG Response Criteria, (Cheson, 1999).
CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.
Cru: Criteria for CR above but with 1 or more of the following:
A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
- Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).
Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.
CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.
Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes
- Stage 2: Duration of Overall Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants [ Time Frame: Approximately 3.5 years ]Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) was to be calculated for responders as the time from documented initial response (either CR, CRu, or PR) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.
- Stage 2: Overall Survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) ParticipantsOverall Survival (OS) is defined as the time from randomization until death due to any cause.
- Stage 2: Duration of Complete Response for Diffuse Large B-Cell Lymphoma (DLBCL) ParticipantsDuration of Complete Response was to be calculated for complete responders as the time of from documented initial complete response (either CR or CRu) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.
- Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Patients With a Duration of Response Lasting ≥ 16 Weeks
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).
Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.
CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.
Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes
- Stage 2: Time to Progression for Diffuse Large B-Cell Lymphoma (DLBCL) ParticipantsTime to progression is defined as the time from the start of study drug therapy to the first documentation of disease progression
- Stage 2: Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) PatientsThe European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) is a 30-item oncology-specific questionnaire developed to assess the quality of life of cancer patients. The descriptive system EQ-5D is a generic questionnaire consisting of 3 levels within each of the 5 domains. It's is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197560

United States, California | |
Providence St Joseph Medical Center/Cancer Center | |
Burbank, California, United States, 91505 | |
United States, Florida | |
MD Anderson Cancer Center Orlando | |
Orlando, Florida, United States, 32806 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Maryland | |
Center for Cancer and Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
United States, Michigan | |
University of Michigan, Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48105 | |
United States, Mississippi | |
Hattiesburg Clinic | |
Hattiesburg, Mississippi, United States, 39402 | |
United States, Missouri | |
Washington University Siteman Cancer Center | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 | |
United States, South Dakota | |
Avera Cancer Institute | |
Sioux Falls, South Dakota, United States, 57105 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
MD Anderson Houston | |
Houston, Texas, United States, 77030 | |
Australia | |
Royal Adelaide Hospital | |
Adelaide, Australia, 5000 | |
Royal Brisbaine and Womens Hospital | |
Herston, Australia, 4029 | |
Princess Alexandra Hospital | |
Woolloongabba, Australia, 4102 | |
Austria | |
Innsbruck University Hospital | |
Innsbruck, Austria, A6020 | |
Universitätsklinikum Salzburg | |
Salzburg, Austria, A-5020 | |
Medical University of Vienna | |
Vienna, Austria, A-1090 | |
Czechia | |
University Hospital Hradec Kralove | |
Hradec Kralove 5, Czechia, 5005 | |
Charles University | |
Praha, Czechia, 12808 | |
France | |
ICH CHU Brest- C.H.U. MORAVAN | |
Brest Cedex 2, France, 29609 | |
CHU de Grenoble-Hopital Albert Michallon | |
Grenoble, France, 38043 | |
Chd -Vendee | |
La Roche Sur Yon, France, 85205 | |
Centre Hospitalier Lyon Sud | |
Lyon, France, 69495 | |
Institute Paoli-Calmette | |
Marsielle, France, 13009 | |
Hotel Dieu | |
Nantes Cedex 1, France, 44903 | |
Hôpital Saint Jean | |
Perpignan, France, 66046 | |
CHRU-Hopital du Haut -Leveque | |
Pessac, France, 33604 | |
CHU de Rennes Hopital de Pontchaillou | |
Rennes, France, 35033 | |
University Hospital OF Toulouse Purpan | |
Toulouse, France, 31059 | |
Hopital de Brabois Adultes | |
Vandoeuvre-les Nancy cedex, France, 54511 | |
Italy | |
Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico | |
Bologna, Italy, 40138 | |
Azienda Ospedaliera Universitaria Careggi | |
Firenze, Italy, 50141 | |
Clinica Ematologica, A.O.U. San Martino di Genova | |
Genova, Italy, 16132 | |
IEO istituto Europeo di Oncologia | |
Miano, Italy, 201401 | |
Universita Federico II di Napoli Nuovo Policlinico | |
Napoli, Italy, 80131 | |
Fondazione IRCCS Policlinico San Matteo | |
Pavia, Italy, 27100 | |
Irccs/Crob | |
Rionero In Vulture (PZ), Italy, 85208 | |
Policlinico Tor Vergata (Universta Tor Vergata) | |
Roma, Italy, 00133 | |
Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri | |
Terni, Italy, 6156 | |
Spain | |
Hospital Universitari Vll D' Hebron | |
Barcelona, Spain, 8035 | |
Hospital Universitario Reina Sofia | |
Cordoba, Spain, 14004 | |
Hospital Costa Del Sol | |
Marbella, Spain, 29600 | |
CH de Orense | |
Ourense, Spain, 32005 | |
Complejo Hospitalario de Navarra | |
Pamplona, Spain, 31008 | |
Hosptial Clinico Universitario de Salamanca | |
Salamanca, Spain, 37007 | |
Sweden | |
Onkologiska kliniken | |
Umea, Sweden, 90185 | |
Akademiska Sjukhuset | |
Uppsala, Sweden, 75185 | |
United Kingdom | |
Royal Bournemouth Hospital Haematology | |
Bournemouth, United Kingdom, BH7 7DW | |
Royal Devon and Exeter Hospital Haematology Department | |
Exeter, United Kingdom, EX2 5DW | |
St. James Institute of Oncology | |
Leeds, United Kingdom, LS9 7TF | |
Royal Mardsen Hospital - Fulham (Satellite Site) | |
London, United Kingdom, SW3 6U | |
The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team | |
Manchester, United Kingdom, M20 4BX | |
Derrford Hospital | |
Plymouth, United Kingdom, PL6 8DH | |
Southhampton University Hospital NHS Trust | |
Southhampton, United Kingdom, SO16 6YD | |
Royal Mardsen NHS Foundation Trust | |
Sutton, United Kingdom, SM2 SPT |
Study Director: | Adrian Kilcoyne, MD | Celgene Corporation |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT01197560 History of Changes |
Other Study ID Numbers: |
CC-5013-DLC-001 |
First Posted: | September 9, 2010 Key Record Dates |
Results First Posted: | August 20, 2014 |
Last Update Posted: | January 19, 2018 |
Last Verified: | December 2017 |
Keywords provided by Celgene:
Diffuse Large B-Cell Lymphoma Non Hodgkin's Lymphoma relapsed refractory |
relapsed/refractory DLBCL Diffuse Large B Cell Lymphoma |
Additional relevant MeSH terms:
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Gemcitabine Etoposide Thalidomide Oxaliplatin Lenalidomide |
Etoposide phosphate Rituximab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents |