A phase 2 multicenter study of lenalidomide in relapsed or refractory classical Hodgkin lymphoma

Blood. 2011 Nov 10;118(19):5119-25. doi: 10.1182/blood-2011-07-362475. Epub 2011 Sep 21.

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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Cell Line, Tumor
  • Chemokine CCL17 / blood
  • Chemokine CCL22 / blood
  • Disease-Free Survival
  • Female
  • Hodgkin Disease / blood
  • Hodgkin Disease / drug therapy*
  • Hodgkin Disease / therapy
  • Humans
  • Kaplan-Meier Estimate
  • Lenalidomide
  • Male
  • Middle Aged
  • Prospective Studies
  • Recurrence
  • Remission Induction
  • Stem Cell Transplantation
  • Thalidomide / adverse effects
  • Thalidomide / analogs & derivatives*
  • Thalidomide / therapeutic use

Substances

  • Antineoplastic Agents
  • CCL17 protein, human
  • CCL22 protein, human
  • Chemokine CCL17
  • Chemokine CCL22
  • Thalidomide
  • Lenalidomide

Associated data

  • ClinicalTrials.gov/NCT00540007