Phase III Randomized Study of Bendamustine Compared With Chlorambucil in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Knauf, Wolfgang; Lissichkov, Toshko; Aldaoud, Ali; Liberati, A. M.; Loscertales, Javier; Herbrecht, Raoul; Juliusson, Gunnar; Postner, Gerhard; Gercheva-Kyuchukova, Liana; Goranov, S; Becker, Martin; Fricke, Hans; Huguet, Françoise; Giudice, Ilaria Del; Klein, Peter; Tremmel, Lothar; Merkle, K; Montillo, Marco

doi:10.1200/jco.2008.20.8389

Cited by 398 publications

(316 citation statements)

References 32 publications

(10 reference statements)

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“…The trial provided very satisfactory results: the response rate-82.4% OR, including 16.5% CR and 2.4% CRi, with cytometric MRD2 in 14% of CR cases-compares favorably with the 31-55% OR rates of trials using single-agent CLB at comparable doses [7,8,23], the 72% OR of the LRF CLL4 trial, using higher doses of single-agent CLB [6] and is supported by a similar British trial using CLB-R (OR 82%) [11]. Furthermore, in our study, PFS (34.7 months) is higher than that reported in trials using single-agent CLB (8.3-18 months) [6][7][8]12,23]. A preliminary analysis of the German CLL11 trial, comparing CLB alone, obinutuzumab 1 CLB, and CLB-R in untreated CLL patients with comorbidities, has been released [12].…”

Section: Discussionmentioning

confidence: 84%

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Chlorambucil plus rituximab with or without maintenance rituximab as first‐line treatment for elderly chronic lymphocytic leukemia patients

et al. 2014

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In a phase II trial, we evaluated chlorambucil and rituximab (CLB-R) as first-line induction treatment with or without R as maintenance for elderly chronic lymphocytic leukemia (CLL) patients. Treatment consisted of eight 28-day cycles of CLB (8 mg/m 2 /day, days 1-7) and R (day 1 of cycle 3, 375 mg/m 2 ; cycles 4-8, 500 mg/ m 2 ). Responders were randomized to 12 8-week doses of R (375 mg/m 2 ) or observation. As per intention-totreat analysis, 82.4% (95% CI, 74.25-90.46%) of 85 patients achieved an overall response (OR), 16.5% a complete response (CR), 2.4% a CR with incomplete bone marrow recovery. The OR was similar across Binet stages (A 86.4%, B 81.6%, and C 78.6%) and age categories (60-64 years, 92.3%; 65-69, 85.2%; 70-74, 75.0%; 75, 81.0%). CLB-R was well tolerated. After a median follow-up of 34.2 months, the median progression-free survival (PFS) was 34.7 months (95% CI, 33.1-39.5). TP53 abnormalities, complex karyotype, and low CD20 gene expression predicted lack of response; SF3B1 mutation and BIRC3 disruption low CR rates. IGHV mutations significantly predicted PFS. R maintenance tended towards a better PFS than observation and was safe and most beneficial for patients in partial response and for unmutated IGHV cases. CLB-R represents a promising option for elderly CLL patients.

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Section: Discussionmentioning

confidence: 84%

“…Infections occurred in 15.5% of patients, although rarely of grade 3-4 (1%). Thus, CLB-R toxicity compares favorably with other trials using CLB alone or with R [6][7][8]11,23]. Infusion-related side effects were limited.…”

Section: Discussionmentioning

confidence: 90%

Chlorambucil plus rituximab with or without maintenance rituximab as first‐line treatment for elderly chronic lymphocytic leukemia patients

et al. 2014

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“…However, there were only two so-called "anecdotal transient hemolysis" among 162 patients treated with bendamustine alone [18] and none in the German experience of BR in 195 patients with untreated or relapsed CLL [9,10]. The forthcoming results of the CLL10 trial of the German CLL study group having compared FCR to BR in previously untreated CLL patients will provide further information on the risk of bendamustine-induced AIHA in a larger cohort [19].…”

Section: Discussionmentioning

confidence: 99%

Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia‐associated autoimmune hemolytic anemia: A multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS)

et al. 2015

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We report our experience on bendamustine and rituximab (BR) combination in 26 patients with chronic lymphocytic leukemia (CLL) complicated by autoimmune hemolytic anemia (AIHA). At the time of BR initiation, 88% of the patients had already been treated for AIHA and CLL was progressive regardless of AIHA in all patients but one. Overall response rates were 81% for AIHA and 77% for CLL. Median time to next treatment was 28.3 months and 26.2 months for AIHA and CLL, respectively. BR therapy may represent a good and safe therapeutic option in this setting where adequate control of CLL seems important for longterm AIHA response.

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“…Bendamustine has been approved for previously untreated CLL based on superiority in CR and PFS compared with chlorambucil [21]. Given the promising efficacy and safety data with bendamustine and rituximab (BR) in the front-line setting, the GCLLSG conducted the phase III CLL10 trial of BR versus FCR Supplementary Table S1 Supplementary Table S2 Supplementary Data in previously untreated, physically fit patients [22].…”

Section: Discussionmentioning

confidence: 99%

Lenalidomide following fludarabine and rituximab in previously untreated CLL

Ujjani¹,

Paulus²,

Gehan³

et al. 2015

Hematol Leuk

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Fludarabine-based regimens have overall response rates (ORR) of 90-95% in untreated chronic lymphocytic leukemia (CLL), but almost all patients inevitably relapse. Given the promising activity of lenalidomide in relapsed/refractory CLL, we studied the combination of fludarabine and rituximab (FR) followed by lenalidomide in untreated disease (n=22). Patients received three cycles (C) of FR (F 25 mg/m 2 days (D) 1-5, R 375 mg/m 2 D1). Those who responded received three more cycles of FR followed by three cycles of lenalidomide; whereas patients with stable or progressive disease switched to lenalidomide (5 mg C1D1-21, 10 mg in subsequent cycles). After three cycles of lenalidomide, patients with a response or stable disease received another three cycles, whereas those who progressed were removed. The ORR with FR was 77% (complete response (CR) 23%). With lenalidomide (n=15), three converted from a partial response to CR, increasing the CR rate to 36%. The most common >grade 3 toxicity was neutropenia (59%). The median progression-free survival was 38.5 months (95% CI: 32.0, 53.9) and the median overall survival had not yet been reached at the time of analysis. The study demonstrated the feasibility of FR-L when administered in a sequential manner.

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Phase III Randomized Study of Bendamustine Compared With Chlorambucil in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Abstract: Bendamustine offers significantly greater efficacy than chlorambucil, and a manageable toxicity profile, when used as first-line therapy in patients with advanced CLL.

Cited by 398 publications

References 32 publications

Chlorambucil plus rituximab with or without maintenance rituximab as first‐line treatment for elderly chronic lymphocytic leukemia patients

Chlorambucil plus rituximab with or without maintenance rituximab as first‐line treatment for elderly chronic lymphocytic leukemia patients

Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia‐associated autoimmune hemolytic anemia: A multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS)

Lenalidomide following fludarabine and rituximab in previously untreated CLL

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