A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Sponsor: Celgene Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00474188
• Collaborator: (none)
• Enrollment: 26
• Locations: 24
• Arm: 1
• Duration (Months): 19.1
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma	Drug: CC-5013 (lenalidomide); Drug: dexamethasone	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Single Arm

Drug: CC-5013 (lenalidomide); 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; Other Names: CC-5013 lenalidomide Revlimid ; Drug: dexamethasone; 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.; Other Names: Decadron

Outcome Measures

Primary Outcome Measures

1. Tumor Response Rate [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.

Secondary Outcome Measures

1. Tumor Control Rate [One Year]

   Number of participants demonstrating complete tumor response, partial tumor response, or stable disease. Study terminated prematurely. Analysis not conducted.

2. Duration of Response [One year]

   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.

3. Time to Progression [One year]

   Time from the start of study drug therapy to the first documentation of disease progression. Study terminated prematurely. Analysis not conducted.

4. Progression-free Survival [One year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Verde Hematology/Oncology, Ltd.	Glendale	Arizona	United States	85304
2	Tower Cancer Research Foundation	Beverly Hills	California	United States	90211
3	Advanced Medical Specialties	Miami	Florida	United States	33176
4	Hematology/Oncology Associates of Treasure Coast	Port St. Lucie	Florida	United States	34952
5	Northwest Georgia Oncology Centers	Marietta	Georgia	United States	30060
6	Cancer Care & Hematology Specialists of Chicagoland	Arlington Heights	Illinois	United States	60005
7	Northwestern University, Feinberg School of Medicine	Chicago	Illinois	United States	60611
8	Rush University Medical Center	Chicago	Illinois	United States	60612
9	University of Kentucky	Lexington	Kentucky	United States	40536
10	Southwest Oncology Associates	Lafayette	Louisiana	United States	70503
11	Washington County Hospital, The Center for Clinical Research	Hagerstown	Maryland	United States	21742
12	Kalamazoo Hematology & Oncology	Kalamazoo	Michigan	United States	49048
13	Oncology & Hematology Specialists, PA	Denville	New Jersey	United States	07834
14	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
15	Northwestern Carolina, Oncology and Hematology PA	Hickory	North Carolina	United States	28602
16	New Bern Cancer Care	New Bern	North Carolina	United States	28562
17	James Cancer Hospital	Columbus	Ohio	United States	43210
18	SouthWest Regional Cancer Center	Austin	Texas	United States	78705
19	Northern Utah Associates	Ogden	Utah	United States	84403
20	The Alfred Hospital	Melbourne	Victoria	Australia	VIC3050
21	Frankston Hospital	Frankston		Australia	VIC 3199
22	HOCA	South Brisbane		Australia	QLD 4101
23	Border Medical Oncology	Wodonga		Australia	VIC 3690
24	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2

Sponsors and Collaborators

• Celgene Corporation

Investigators

• Principal Investigator: Andrew Spencer, MD, The Alfred

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00474188
• Other Study ID Numbers: CC-5013-NHL-005
• First Posted: May 16, 2007
• Last Update Posted: Sep 2, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: 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
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Dexamethasone; Lenalidomide

Study Results

Participant Flow

Arm/Group Title	Lenalidomide in Combination With Dexamethasone
Arm/Group Description	Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
Period Title: Overall Study
STARTED	26
COMPLETED	20
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Lenalidomide in Combination With Dexamethasone
Arm/Group Description	Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
Overall Participants	26
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 38.5%
>=65 years	16 61.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.7 (11.42)
Sex: Female, Male (Count of Participants)
Female	10 38.5%
Male	16 61.5%
Region of Enrollment (participants) [Number]
Australia	4 15.4%
Canada	2 7.7%
United States	20 76.9%

Outcome Measures

1. Primary Outcome

Title	Tumor Response Rate
Description	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.
Time Frame	One Year

Outcome Measure Data

Analysis Population Description

Study terminated prematurely. Analyses of efficacy not conducted.

Arm/Group Title	Lenalidomide in Combination With Dexamethasone
Arm/Group Description	Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
Measure Participants	0

2. Secondary Outcome

Title	Tumor Control Rate
Description	Number of participants demonstrating complete tumor response, partial tumor response, or stable disease. Study terminated prematurely. Analysis not conducted.
Time Frame	One Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lenalidomide in Combination With Dexamethasone
Arm/Group Description	Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
Measure Participants	0

3. Secondary Outcome

Title	Duration of Response
Description	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.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lenalidomide in Combination With Dexamethasone
Arm/Group Description	Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
Measure Participants	0

4. Secondary Outcome

Title	Time to Progression
Description	Time from the start of study drug therapy to the first documentation of disease progression. Study terminated prematurely. Analysis not conducted.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lenalidomide in Combination With Dexamethasone
Arm/Group Description	Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
Measure Participants	0

5. Secondary Outcome

Title	Progression-free Survival
Description	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.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lenalidomide in Combination With Dexamethasone
Arm/Group Description	Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
Measure Participants	0

Adverse Events

Limitations/Caveats

Study terminated prematurely as a business decision. Analyses of efficacy not conducted.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The investigator shall have the right to publish and/or present the data generated from the study provided that the investigator shall (i) furnish the sponsor with a copy of any proposed publication or presentation at least thirty (30) days in advance of the submission of such material, (ii) delete from such material any confidential information of the sponsor, and (iii) delay submission of same for up to sixty (60) days to permit the preparation and filing of intellectual property applications.