Clinical trial NCT00474188: A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Duration of Response
Time to Progression
Progression-free survival and safety
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor Response Rate
timeFrame: One Year
Secondary outcomes:
measure: Tumor Control Rate
timeFrame: One Year
measure: Duration of Response
timeFrame: One year
measure: Time to Progression
timeFrame: One year
measure: Progression-free Survival
timeFrame: One year
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Palo Verde Hematology/Oncology, Ltd.
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology/Oncology Associates of Treasure Coast
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Arlington Heights
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lafayette
country: United States
facility: Southwest Oncology Associates
state: Louisiana
city: Hagerstown
country: United States
facility: Washington County Hospital, The Center for Clinical Research
state: Maryland
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology & Oncology
state: Michigan
city: Denville
country: United States
facility: Oncology & Hematology Specialists, PA
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hickory
country: United States
facility: Northwestern Carolina, Oncology and Hematology PA
state: North Carolina
city: New Bern
country: United States
facility: New Bern Cancer Care
state: North Carolina
city: Columbus
country: United States
facility: James Cancer Hospital
state: Ohio
city: Austin
country: United States
facility: SouthWest Regional Cancer Center
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
city: South Brisbane
country: Australia
facility: HOCA
city: Wodonga
country: Australia
facility: Border Medical Oncology
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: The Alfred
name: Andrew Spencer, MD
role: PRINCIPAL_INVESTIGATOR
References: