The purpose of this study is to determine the efficacy of lenalidomide in the treatment of relapsed or refractory classic Hodgkin lymphoma(cHL).
Hodgkin lymphoma (HL), an uncommon but significant subtype of lymphoma, is divided into classical HL (cHL) and nodular lymphocyte predominant HL (NLPHL). Progress has been made in cHL therapy resulting in 5-year failure free survival rates between 61%-89% even in the setting of advanced stage or bulky disease. Patients who relapse however, have a variable prognosis ranging from a 8-year overall survival rate of less than 8% for patients who never achieve a remission to 54% for patients with a complete remission lasting greater than 12 months. High dose chemotherapy with autologous stem cell support is the standard of care for patients with relapsed cHL but for those that relapse despite aggressive salvage therapy 20 - 50%, with median remission durations of approximately 6 months. Furthermore, a subset of relapsed HL patients may not be candidates for aggressive salvage regimens. These novel salvage therapies are needed for relapsed/refractory cHL, especially agents without serious late toxicities are particularly attractive in this disease. Advances in the understanding of HL pathogenesis and lenalidomide's mechanisms of action provide substantial rationale for evaluating lenalidomide in HL patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Washington University
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Wake Forest University Medical School
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL.
* Overall response rate = CR + PR * Definitions per 2007 Cheson Lymphoma Response Criteria
Time frame: Through 3.5 years from study entry or until disease progression
Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.
* Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 * The higher the grade the worse the adverse event was considered
Time frame: 30 days following the completion of treatment
Cytostatic Overall Response Rate
* Cytostatic overall response rate = CR + PR + SD greater than or equal to 6 months * Definitions per 2007 Cheson Lymphoma Response Criteria
Time frame: From 6 months through 3.5 years after study entry
Participant Response Rate in Relapsed or Refractory cHL.
-Definitions per 2007 Cheson Lymphoma Response Criteria
Time frame: Through 3.5 years from study entry or until disease progression
Time to Progression (TTP).
-Time to progression (TTP) is defined as the time from study entry until documented lymphoma progression or death as a result of lymphoma.
Time frame: Through 3.5 years from study entry or until disease progression
Overall Survival (OS)
Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause.
Time frame: Through 3.5 years from study entry or until disease progression
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Relapse Free Survival (RFS)
Time frame: Through 3.5 years from study entry or until disease progression
Event Free Survival (EFS).
-Event-free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).
Time frame: Through 3.5 years from study entry or until disease progression
Duration of Response
-Duration of response: defined as the interval from the date of response (CR or PR) is documented to the date of progression, taking as reference the smallest measurements recorded since the treatment started
Time frame: Through 3.5 years from study entry or until disease progression