Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2008 Jul 1;113(1):108-16.
doi: 10.1002/cncr.23537.

Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group

David J Inwards  1 , Paul A S Fishkin, David W Hillman, David W Brown, Stephen M Ansell, Paul J Kurtin, Rafael Fonseca, Roscoe F Morton, Michael H Veeder, Thomas E Witzig
Affiliations
Clinical Trial

Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group

David J Inwards et al. Cancer. .

Abstract

Background: The objective of this study was to test cladribine (2-CDA) alone and in combination with rituximab in patients with mantle cell lymphoma (MCL).

Methods: Patients with MCL were treated on 2 sequential trials. In Trial 95-80-53, patients received 2-CDA as initial therapy or at relapse. In Trial N0189, patients received combination 2-CDA and rituximab as initial therapy. In both trials, 2-CDA was administered at a dose of 5 mg/m2 intravenously on Days 1 through 5 every 4 weeks for 2 to 6 cycles, depending on response. In Trial N0189, rituximab 375 mg/m2 was administered on Day 1 of each cycle.

Results: Results were reported for 80 patients. Twenty-six previously untreated patients and 25 patients who had recurrent disease with a median age of 68 years received single-agent 2-CDA. The overall response rate (ORR) was 81% with 42% complete responses (CRs) in the previously untreated group. The median progression-free survival (PFS) was 13.6 months (95% confidence interval [95% CI], 7.2-22.1 months), and 81% of patients remained alive at 2 years. The ORR was 46% with a 21% CR rate in the recurrent disease group. The median PFS was 5.4 months (95% CI, 4.6-13.1 months), and 36% of patients remained alive at 2 years. Twenty-nine eligible patients with a median age of 70 years received 2-CDA plus rituximab. The ORR was 66% (19 of 29 patient), and the CR rate was 52% (15 of 29 patients). The median duration of response for patients who achieved a CR had not been reached at the time of the current report, and only 3 of the patients who achieved a CR developed recurrent disease at a median follow-up of 21.5 months.

Conclusions: 2-CDA had substantial single-agent activity in both recurrent and untreated MCL, and the results indicated that it may be administered safely to elderly patients. The addition of rituximab to 2-CDA may increase the duration of response.

PubMed Disclaimer

Figures

FIGURE 1
FIGURE 1
Progression-free and overall survival of patients with newly diagnosed or recurrent mantle cell lymphoma who received cladribine.
FIGURE 2
FIGURE 2
Progression-free and overall survival of patients with newly diagnosed mantle cell lymphoma who received rituximab plus cladribine.
See this image and copyright information in PMC

References

    1. Zelenetz AD. Mantle cell lymphoma: an update on management. Ann Oncol. 2006;17(suppl 4):iv12–iv14. - PubMed
    1. Witzig TE. Current treatment approaches for mantle-cell lymphoma. J Clin Oncol. 2005;23:6409–6414. - PubMed
    1. Bertoni F, Zucca E, Cotter FE. Molecular basis of mantle cell lymphoma. Br J Haematol. 2004;124:130–140. - PubMed
    1. Kurtin PJ. Mantle cell lymphoma. Adv Anat Pathol. 1998;5:376–398. - PubMed
    1. Kurtin PJ, Hobday KS, Ziesmer S, Caron BL. Demonstration of distinct antigenic profiles of small B-cell lymphomas by paraffin section immunohistochemistry. Am J Clin Pathol. 1999;112:319–329. - PubMed

Publication types