title: A phase 2 multicenter study of lenalidomide in relapsed or refractory classical Hodgkin lymphoma.
abstract: Relapsed or refractory (rel/ref) classical Hodgkin lymphoma (cHL) remains a clinical challenge, with limited effective treatment options available after stem cell transplantation. In a multicenter phase 2 study, the efficacy of lenalidomide in rel/ref cHL patients was evaluated at a dose of 25 mg/d on days 1-21 of a 28-day cycle. Patients remained on lenalidomide until disease progression or an unacceptable adverse event (AE) occurred. Thirty-eight cHL patients were enrolled with a median of 4 (range, 2-9) prior therapies; 87% had undergone prior stem cell transplantation and 55% of patients did not respond to their last prior therapy. Of 36 evaluable patients, responses were 1 complete remission (CR), 6 partial remissions (PRs), and 5 patients with stable disease (SD) for ≥ 6 months resulting in an International Working Committee (IWC) objective overall response rate (ORR) of 19% and a cytostatic ORR of 33%. Decreased chemokine (CCL17 and CCL22) plasma levels at 2 weeks were associated with a subsequent response. The treatment was well tolerated, and the most common grade 3/4 AEs were neutropenia (47%), anemia (29%), and thrombocytopenia (18%). Four patients discontinued lenalidomide because of rash, elevated transaminases/bilirubin, and cytopenias. We provide preliminary evidence of lenalidomide's activity in patients with rel/ref cHL, and therefore exploration of lenalidomide in combination with other active agents is warranted. This trial is registered at www.ClinicalTrials.gov as NCT00540007.
authors.affiliation: Division of Oncology, Washington University School of Medicine, St Louis, MO 63110, USA. tfehnige@wustl.edu
authors.forename: Todd A
authors.initials: TA
authors.lastname: Fehniger
authors.forename: Sarah
authors.initials: S
authors.lastname: Larson
authors.forename: Kathryn
authors.initials: K
authors.lastname: Trinkaus
authors.forename: Marilyn J
authors.initials: MJ
authors.lastname: Siegel
authors.forename: Amanda F
authors.initials: AF
authors.lastname: Cashen
authors.forename: Kristie A
authors.initials: KA
authors.lastname: Blum
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Fenske
authors.forename: David D
authors.initials: DD
authors.lastname: Hurd
authors.forename: Andre
authors.initials: A
authors.lastname: Goy
authors.forename: Stephanie E
authors.initials: SE
authors.lastname: Schneider
authors.forename: Catherine R
authors.initials: CR
authors.lastname: Keppel
authors.forename: Nina D
authors.initials: ND
authors.lastname: Wagner-Johnston
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Carson
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Bartlett
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D045744:Cell Line, Tumor; D054414:Chemokine CCL17 / Q000097:blood; D054422:Chemokine CCL22 / Q000097:blood; D018572:Disease-Free Survival; D005260:Female; D006689:Hodgkin Disease / Q000097:blood / Q000188:drug therapy* / Q000628:therapy; D006801:Humans; D053208:Kaplan-Meier Estimate; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D033581:Stem Cell Transplantation; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; C106230:CCL17 protein, human; C515482:CCL22 protein, human; D054414:Chemokine CCL17; D054422:Chemokine CCL22; D013792:Thalidomide; D000077269:Lenalidomide