Phase II trial and prediction of response of single agent tipifarnib in patients with relapsed/refractory mantle cell lymphoma: a Groupe d’Etude des Lymphomes de l’Adulte trial

2009 ◽  
Vol 65 (4) ◽  
pp. 781-790 ◽  
Author(s):  
Delphine Rolland ◽  
Vincent Ribrag ◽  
Corinne Haioun ◽  
Herve Ghesquieres ◽  
Fabrice Jardin ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Single Agent ◽  
Prediction Of Response ◽  
Mantle Cell

scholarly journals A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma

Haematologica ◽  
2012 ◽  
Vol 97 (7) ◽  
pp. 1085-1091 ◽  
Author(s):  
C. Renner ◽  
P. L. Zinzani ◽  
R. Gressin ◽  
D. Klingbiel ◽  
P.-Y. Dietrich ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Single Agent ◽  
Multicenter Phase ◽  
Mantle Cell

Confirmation of the Efficacy and Safety of Lenalidomide Oral Monotherapy in Patients with Relapsed or Refractory Mantle-Cell Lymphoma: Results of An International Study (NHL-003)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 262-262 ◽  
Author(s):  
Pier Luigi Zinzani ◽  
Thomas E. Witzig ◽  
Julie M. Vose ◽  
Craig B. Reeder ◽  
Rena Buckstein ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Single Agent ◽  
Progression Free Survival ◽  
Prior Treatment ◽  
Efficacy And Safety ◽  
Mantle Cell ◽  
Measurable Disease

Abstract Introduction: Mantle-cell lymphoma (MCL) is a type of B-cell non-Hodgkin lymphoma (NHL) that typically responds to initial chemo-immunotherapy, but with a relatively short duration of response (DR) and progression-free survival (PFS) when treated with conventional chemotherapy agents. Although the overall survival (OS) of MCL has improved, most patients are not cured and new agents are needed. A sub-analysis of a recent phase II trial (NHL-002) investigating the efficacy and safety of lenalidomide in patients with relapsed or refractory MCL, demonstrated a promising overall response rate (ORR) of 53% with a median DR of 11.9 months. A confirmatory international phase II trial (NHL-003) of single-agent lenalidomide was initiated for patients with relapsed/refractory aggressive NHL that had received at least one prior treatment and had measurable disease. In this report, we analyze the current results from the MCL patients enrolled in this trial. Methods: Patients with relapsed or refractory MCL and measurable disease ≥2 cm after at least 1 prior treatment regimen were eligible. Patients received 25 mg of lenalidomide orally once daily on days 1–21 of every 28-day cycle. Patients continued therapy until disease progression or toxicity. The 1999 IWLRC methodology was used to assess response and progression. Results: This report focuses on the 39 MCL patients that were enrolled and evaluable for response assessment. Median age was 66 (33–82) years and 29 (74%) patients were male. Median time from diagnosis to lenalidomide treatment was 3.4 (0.4–9) years. Patients had received a median of 3 (1–8) prior treatments, and 23% (9/39) of patients had received prior bortezomib treatment. The ORR with lenalidomide was 41% (16/39), including 13% (5/39) complete response (CR)/unconfirmed CR, and 28% (11/39) partial responses. Ten (26%) patients had stable disease. The most common grade 3 or 4 adverse events were neutropenia (51%) and thrombocytopenia (25%), anemia (13%), fatigue (10%) and febrile neutropenia (10%). Conclusion: These results confirm that lenalidomide oral monotherapy is effective in the treatment of patients with relapsed or refractory MCL, with manageable side effects.

A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03

2009 ◽  
Vol 27 (3) ◽  
pp. 154-159 ◽  
Author(s):  
F. Hitz ◽  
G. Martinelli ◽  
E. Zucca ◽  
R. von Moos ◽  
W. Mingrone ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Newly Diagnosed ◽  
Multicentre Phase ◽  
Mantle Cell

A phase II trial of bortezomib plus lenalidomide for relapsed/refractory mantle cell lymphoma (MCL) (CALGB 50501).

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. TPS223-TPS223 ◽  
Author(s):  
V. A. Morrison ◽  
S. Jung ◽  
J. L. Johnson ◽  
J. Leonard ◽  
B. D. Cheson ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Mantle Cell

scholarly journals Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601

2015 ◽  
Vol 172 (2) ◽  
pp. 208-218 ◽  
Author(s):  
Brian G. Till ◽  
Hongli Li ◽  
Steven H. Bernstein ◽  
Richard I. Fisher ◽  
W. Richard Burack ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Phase Ii ◽  
Induction Therapy ◽  
Phase Ii Trial ◽  
Cell Lymphoma ◽  
Newly Diagnosed ◽  
Mantle Cell

Combined analysis of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8533-8533
Author(s):  
Thomas E. Witzig ◽  
Julie Vose ◽  
Pier Luigi Zinzani ◽  
Thomas Matthew Habermann ◽  
Joseph M. Tuscano ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Phase Ii ◽  
Cell Lymphoma ◽  
Single Agent ◽  
Pooled Analysis ◽  
Prior Treatment ◽  
Second Primary ◽  
Phase Ii Studies ◽  
Venous Thromboembolic Events ◽  
Mantle Cell

8533 Background: Mantle cell lymphoma (MCL) is an aggressive form of non-Hodgkin lymphoma (NHL) with poor prognosis. The immunomodulatory agent lenalidomide shows consistent activity with tolerable safety in multiple phase II studies of relapsed/refractory aggressive NHL (NHL-002 and NHL-003) and MCL post-bortezomib (MCL-001). This pooled analysis further examined the efficacy and safety of single-agent lenalidomide in patients with relapsed/refractory MCL. Methods: Single-agent lenalidomide was given 25 mg/d PO on days 1-21 of 28-day cycles as tolerated for 52 weeks (NHL-002) or until disease progression (NHL-003 and MCL-001). All MCL patients received ≥1 prior treatment, including bortezomib in MCL-001. Efficacy data were examined by independent central review for MCL-001 and NHL-003 and by investigators for NHL-002. Results: 206 patients with relapsed/refractory MCL were studied. The median age was 67 y (range 33-84; 63% ≥65 y), 91% stage III/IV disease and 51% had received ≥4 prior regimens (76% prior bortezomib). Overall response rate (ORR) with lenalidomide was 32% (10% CR/CRu), with a median time to response of 2.1 months and median duration of response (DOR) of 16.6 months (not yet reached in patients with CR/CRu; Table). Kaplan-Meier estimates for median PFS and OS were 5.4 and 23.9 months, respectively. Mean daily dose of lenalidomide was 21 mg. Grade 3/4 AEs included neutropenia (44%), thrombocytopenia (29%), anemia (11%), and fatigue (7%). Other any-grade AEs included tumor flare reaction (7%), venous thromboembolic events (7%), and invasive second primary malignancies (3%). Conclusions: Lenalidomide produced rapid and durable responses in patients with relapsed/refractory MCL, and exhibited a predictable safety profile among 3 phase II studies of lenalidomide in heavily pretreated patients, including prior treatment with bortezomib. Clinical trial information: MCL-001: NCT00737529; NHL-002: NCT00179660; NHL-003: NCT00413036. [Table: see text]

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