A phase 2 multicenter study of lenalidomide in relapsed or refractory classical Hodgkin lymphoma
Mené sur 38 patients atteints d'un lymphome hodgkinien classique récidivant ou réfractaire, cet essai de phase II évalue l'activité antitumorale et la toxicité du lénalidomide
Relapsed or refractory (rel/ref) classical Hodgkin lymphoma (cHL) remains a clinical challenge with limited effective treatments 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 on days 1-21 of a 28-day cycle. Patients remained on lenalidomide until disease progression or an unacceptable adverse event 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 58% of patients did not respond to their last prior therapy. Of 36 evaluable patients, responses were 1 CR, 6 PRs, and 5 patients with SD for ≥ 6 months resulting in an international working committee objective overall response rate (ORR) of 19% and 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 adverse events were neutropenia (47%), anemia (29%), and thrombocytopenia (18%). Four patients discontinued lenalidomide due to rash, elevated transaminases/bilirubin, and cytopenias. Thus, lenalidomide has preliminary evidence of activity in patients with rel/ref cHL, and exploration of lenalidomide in combination with other active agents is warranted. This trial is registered at www.clinicaltrials.gov as NCT00540007.