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Allogeneic Transplant with Reduced Intensity Conditioning Regimens may Overcome the Poor Prognosis of B-Cell Chronic Lymphocytic Leukemia with Unmutated Immunoglobulin Variable Heavy-Chain Gene and Chromosomal Abnormalities (11q– and 17p–)

Authors' Affiliations: ¹ Hospital Clínico Universitario de Salamanca, Salamanca, Spain; ² Hospital Puerta de Hierro, ³ Hospital 12 de Octubre de Madrid, Madrid, Spain; ⁴ Hospital de la Santa Creu i Sant Pau, ⁵ Institut Catalá d'Oncologia, Barcelona, Spain; ⁶ Hospital Germans Trias i Pujol de Badalona, Badalona, Spain; ⁷ Hospital de la Seguridad Social de Jerez de la Frontera, Andalusia, Spain; and ⁸ Hospital La Fe de Valencia, Valencia, Spain

Requests for reprints: Dolores Caballero, Servicio de Hematología, Hospital Clínico Universitario, Paseo de San Vicente s/n 37007, Salamanca, Spain. Phone: 34-923291316; Fax: 011-34-923294624; E-mail: cabarri{at}usal.es.

Purpose: To evaluate the efficacy of reduced intensity conditioning (RIC) allogeneic transplant in 30 patients with poor-prognosis chronic lymphocytic leukemia (CLL) and/or high-risk molecular/cytogenetic characteristics.

Experimental Design: Eighty-three percent of patients had active disease at the moment of transplant. That is, 14 of the 23 patients analyzed (60%) had unmutated immunoglobulin variable heavy-chain gene (IgV_H) status; 8 of 25 patients (32%) had 11q–, with four of them also displaying unmutated IgV_H; and six (24%) had 17p– (five were also unmutated).

Results: After a median follow-up of 47.3 months, all 22 patients alive are disease free; overall survival and event-free survival (EFS) at 6 years were 70% and 72%, respectively. According to molecular/cytogenetic characteristics, overall survival and EFS for unmutated CLL and/or with 11q– aberration (n = 13) were 90% and 92%, respectively, not significantly different to those with normal in situ hybridization, 13q– and +12, or mutated CLL (n = 7). All six patients with 17p deletion were transplanted with active disease, including three with refractory disease; all except one reached complete remission after the transplant and two are alive and disease free. Nonrelapse mortality (NRM) was 20%; more than two lines before transplant is an independent prognostic factor for NRM (P = 0,02), EFS (P = 0.02), and overall survival (P = 0.01). Patients older than 55 years have a higher risk of NRM (hazard ratio, 12.8; 95% confidence interval, 1.5-111). Minimal residual disease was monitored by multiparametric flow cytometry in 21 patients. Clearance of CD79/CD5/CD19/CD23 cells in bone marrow was achieved in 68% and 94% of the patients at days 100 and 360, respectively.

Conclusion: According to these results, RIC allogeneic transplant could overcome the adverse prognosis of patients with unmutated CLL as well as those with 11q– or 17p–.