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- Title
Lenalidomide in combination with R- ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group.
- Authors
Martín, Alejandro; Redondo, Alba M.; Dlouhy, Iván; Salar, Antonio; González‐Barca, Eva; Canales, Miguel; Montes‐Moreno, Santiago; Ocio, Enrique M.; López‐Guillermo, Armando; Caballero, Dolores
- Abstract
Diffuse large B-cell lymphoma ( DLBCL) patients failing rituximab-containing therapy have a poor outcome with the current salvage regimens. We conducted a phase 1b trial to determine the maximum tolerated dose ( MTD) of lenalidomide in combination with R- ESHAP (rituximab, etoposide, cisplatin, cytarabine, methylprednisolone) ( LR- ESHAP) in patients with relapsed or refractory DLBCL. Efficacy data were collected as a secondary objective. Subjects received 3 cycles of lenalidomide at escalating doses (5, 10 or 15 mg) given on days 1-14 of every 21-day cycle, in combination with R- ESHAP. Responding patients received BEAM (carmustine, etoposide, cytarabine, melphalan) followed by autologous stem-cell transplantation. Lenalidomide 10 mg/d was identified as the MTD because, in the 15 mg cohort, one patient experienced dose-limiting toxicity (grade 3 angioedema) and two patients had mobilization failure. A total of 19 patients (3, 12 and 4 in the 5, 10 and 15 mg cohorts, respectively) were evaluable. All toxicities occurring during LR- ESHAP cycles resolved appropriately and no grade 4-5 non-haematological toxicities were observed. The complete remission and overall response rates were 47·4% and 78·9%, respectively. With a median follow-up of 24·6 (17·4-38·2) months, the 2-year progression-free survival and overall survival were 44% and 63%, respectively. In conclusion, the LR- ESHAP regimen is feasible and yields encouraging outcomes.
- Subjects
COMBINATION drug therapy; DRUG efficacy; DRUG dosage; DIFFUSE large B-cell lymphomas; DISEASE relapse; CLINICAL trials; THERAPEUTICS
- Publication
British Journal of Haematology, 2016, Vol 173, Issue 2, p245
- ISSN
0007-1048
- Publication type
Article
- DOI
10.1111/bjh.13945