Diffuse Large B-cell LymphomaPhase 2NCT00474188
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 study testing CC-5013 (lenalidomide) and dexamethasone in people with Diffuse Large B-cell Lymphoma, run by Celgene Corporation at 24 sites in 3 countries.
Trial summary
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- CC-5013 (lenalidomide) and dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 24 sitesin 3 countries
- Study dates
- May 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
- Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
- Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
- ECOG performance score of 0,1 or 2
- Willing to follow the pregnancy precautions
Who cannot join
- Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- Platelet count < 60,000/mm3 (60 x 109/L).
- Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
- Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
Show all 10Show fewer
- History of active CNS lymphoma within the previous 3 months
- Subjects not willing or unable to take DVT prophylaxis
- History of other malignancies within the past year
- Positive HIV or active Hepatitis B or C
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States19 sites
Cancer Care & Hematology Specialists of Chicagoland
Arlington Heights, Illinois, 60005
SouthWest Regional Cancer Center
Austin, Texas, 78705
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
James Cancer Hospital
Columbus, Ohio, 43210
Oncology & Hematology Specialists, PA
Denville, New Jersey, 07834
Palo Verde Hematology/Oncology, Ltd.
Glendale, Arizona, 85304
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Washington County Hospital, The Center for Clinical Research
Hagerstown, Maryland, 21742
Northwestern Carolina, Oncology and Hematology PA
Hickory, North Carolina, 28602
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, 49048
Southwest Oncology Associates
Lafayette, Louisiana, 70503
University of Kentucky
Lexington, Kentucky, 40536
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060
Advanced Medical Specialties
Miami, Florida, 33176
New Bern Cancer Care
New Bern, North Carolina, 28562
Northern Utah Associates
Ogden, Utah, 84403
Hematology/Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952
Australia4 sites
Frankston Hospital
Frankston, VIC 3199
The Alfred Hospital
Melbourne, Victoria, VIC3050
HOCA
South Brisbane, QLD 4101
Border Medical Oncology
Wodonga, VIC 3690
About this study
Official title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
Read the detailed description
Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis, with median survival time as long as 10 years, but they are not usually curable in advanced stages. Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive type of NHL has a shorter natural history; approximately 50-60% of these subjects can be cured with combination chemotherapy regimens. Even with recent advances, many patients with advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of subjects who will eventually relapse or who are refractory to treatment.
Due to the variation in the clinical behavior of the different types of aggressive NHL, it is important to test lenalidomide in DLBCL. Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is important to test lenalidomide in combination therapy. This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- CC-5013 (lenalidomide), dexamethasone
- Keywords
- Celgene, Revlimid, Lenalidomide, Diffuse Large B-cell lymphoma, Non-Hodgkins lymphoma, CC-5013, Response Rate, Tumor Control Rate, Duration of Response, Time to Progression, Progression-free survival and safety
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5013 (lenalidomide)Drug
Also called CC-5013, lenalidomide, Revlimid
Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
dexamethasoneDrug
Also called Decadron
Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: CC-5013 (lenalidomide); Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response Rate
Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53).
Study terminated prematurely. Analysis not conducted.
Measured: One Year
Secondary outcomes (4)
Tumor Control Rate
Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.
Study terminated prematurely. Analysis not conducted.
Measured: One Year
Duration of Response
Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma.
Study terminated prematurely. Analysis not conducted.
Measured: One year
Time to Progression
Time from the start of study drug therapy to the first documentation of disease progression.
Study terminated prematurely. Analysis not conducted.
Measured: One year
Progression-free Survival
Time from the start of study drug therapy to the first observation of disease progression or death due to any cause.
Study terminated prematurely. Analysis not conducted.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Spencer, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474188
- Sponsor's protocol ID
- CC-5013-NHL-005
- Status last verified
- Aug 2009
- First submitted
- 14 May 2007
- Last updated
- 2 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00474188
- Acronym / sponsor ID
- CC-5013-NHL-005
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Celgene, Revlimid, Lenalidomide, Diffuse Large B-cell lymphoma, Non-Hodgkins lymphoma, CC-5013, Response Rate, Tumor Control Rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Posted 13 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
Detailed description
Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis, with median survival time as long as 10 years, but they are not usually curable in advanced stages. Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive type of NHL has a shorter natural history; approximately 50-60% of these subjects can be cured with combination chemotherapy regimens. Even with recent advances, many patients with advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of subjects who will eventually relapse or who are refractory to treatment.
Due to the variation in the clinical behavior of the different types of aggressive NHL, it is important to test lenalidomide in DLBCL. Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is important to test lenalidomide in combination therapy. This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: CC-5013 (lenalidomide), Drug: dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
- Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
- Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
- ECOG performance score of 0,1 or 2
- Willing to follow the pregnancy precautions
Key exclusion criteria (10 listed)
- Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- Platelet count < 60,000/mm3 (60 x 109/L).
- Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-5013 (lenalidomide)Also: CC-5013, lenalidomide, RevlimidLenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle | Drug | Single Arm |
| dexamethasoneAlso: DecadronDexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle. | Drug | Single Arm |
Primary outcome
Tumor Response Rate
Time frame: One Year
Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted.
4 secondary outcomes
Tumor Control Rate
Time frame: One Year
Duration of Response
Time frame: One year
Time to Progression
Time frame: One year
Progression-free Survival
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Spencer, MD principal investigator
The Alfred
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-5013 (lenalidomide) and dexamethasone in people with Diffuse Large B-cell Lymphoma, run by Celgene Corporation at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response Rate (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2009.