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

Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00474188
• Other study ID #: CC-5013-NHL-005
• Status: Terminated
• Phase: Phase 2
• First received: May 14, 2007
• Last updated: August 27, 2009
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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
• 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.

Locations

Country	Name	City	State
Australia	Frankston Hospital	Frankston
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	HOCA	South Brisbane
Australia	Border Medical Oncology	Wodonga
Canada	Cross Cancer Institute	Edmonton	Alberta
United States	Cancer Care & Hematology Specialists of Chicagoland	Arlington Heights	Illinois
United States	SouthWest Regional Cancer Center	Austin	Texas
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	James Cancer Hospital	Columbus	Ohio
United States	Oncology & Hematology Specialists, PA	Denville	New Jersey
United States	Palo Verde Hematology/Oncology, Ltd.	Glendale	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Washington County Hospital, The Center for Clinical Research	Hagerstown	Maryland
United States	Northwestern Carolina, Oncology and Hematology PA	Hickory	North Carolina
United States	Kalamazoo Hematology & Oncology	Kalamazoo	Michigan
United States	Southwest Oncology Associates	Lafayette	Louisiana
United States	University of Kentucky	Lexington	Kentucky
United States	Northwest Georgia Oncology Centers	Marietta	Georgia
United States	Advanced Medical Specialties	Miami	Florida
United States	New Bern Cancer Care	New Bern	North Carolina
United States	Northern Utah Associates	Ogden	Utah
United States	Hematology/Oncology Associates of Treasure Coast	Port St. Lucie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response Rate		One Year	No
Secondary	Tumor Control Rate		One Year	No
Secondary	Duration of Response		One year	No
Secondary	Time to Progression		One year	No
Secondary	Progression-free Survival		One year	No