Interim report of a phase 2 clinical trial of lenalidomide for T‐cell non‐Hodgkin lymphoma

Abstract

BACKGROUND: Novel therapies are needed to improve outcomes in T-cell lymphomas. The authors report the interim results of a prospective multicenter trial evaluating lenalidomide in T-cell lymphomas. METHODS: Patients with recurrent and refractory T-cell lymphomas other than mycosis fungoides and untreated patients ineligible for combination chemotherapy were prescribed oral lenalidomide (25 mg daily) on Days 1 to 21 of each 28-day cycle until disease progression, death, or unacceptable toxicity. The primary endpoint was overall response rate. Secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. The 2-stage design allows for up to 40 patients. RESULTS: At the time of this interim analysis, 24 patients were enrolled in this study, and 23 were evaluable for response. The median age was 65 years. The overall response rate was 7 (30%) of 23; all were partial responses. Two patients had stable disease for !5 cycles. Responses were seen in anaplastic, angioimmunoblastic, and peripheral Tcell unspecified histologies. Median PFS was 96 days (range, 8-696þ days). Median OS was 241 days (range, 8-696þ days). The most common grade 4 adverse event was thrombocytopenia (33%). The most common grade 3 adverse events were neutropenia (21%), febrile neutropenia (17%), and pain not otherwise specified (17%). Rash correlated with response to therapy (P ¼.003). CONCLUSIONS: In patients with recurrent and refractory T-cell lymphomas, oral lenalidomide monotherapy has clinical activity, and toxicity is consistent with the known safety profile of lenalidomide. Further study of lenalidomide in these diseases is warranted. Cancer 2010;116:4541-8.

Therapeutic Effect of Lenalidomide in a Novel Xenograft Mouse Model of Human Blastic NK Cell Lymphoma/Blastic Plasmacytoid Dendritic Cell Neoplasm

“…These data suggest, as previously shown in acute myelog- Therapeutic effect of lenalidomide in the human BNKL mouse model So far, lenalidomide has been used to treat hematologic neoplastic diseases such as multiple myeloma, myelodysplastic syndromes (MDS), and lymphoma (15,16,28,29), with some encouraging evidence of possible clinical activity in colorectal carcinoma (30). We therefore decided to test this drug in our model of human BNKL.…”

Peripheral T-cell lymphoma, not otherwise specified

“…[67][68][69][70] The drug was administered orally starting dose of 25 mg/day for 21 consecutive days on a 28-day cycle. Responses rates varied between 22% and 30%, with CR rates ranging from 8% to 30%; for PTCL-NOS patients specifically, ORR varied from 20% to 43%.…”

The aggressive peripheral T‐cell lymphomas: 2015

“…Pralatrexate [79] and romidepsin [80] have now been approved for use in the United States for relapsed/refractory PTCL. Other new agents, including lenalidomide [81], desatinib [82], and the aurora kinase inhibitor alisertib [83] all show some promise. Autologous transplantation at the time of treatment failure can cure some patients with chemotherapy-sensitive disease [54].…”