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


  • Support and study drug supplies were provided by Ortho Biotech and Genentech.

  • Additional participating institutions include: Siouxland Hematology-Oncology Associates, Sioux City, Iowa (Donald B. Wender, MD); Wichita Community Clinical Oncology Program (CCOP), Wichita, Kan (Shaker R. Dakhil, MD); Duluth CCOP, Duluth, Minn (Daniel A. Nikcevich, MD); Michigan Cancer Research Consortium, Ann Arbor, Mich (Philip J. Stella, MD); Medcenter 1 Health Systems, Bismarck, ND (Edward Wos, MD); Carle Cancer Center CCOP, Urbana, Ill (Kendrith M. Rowland, Jr., MD); Missouri Valley Cancer Consortium, Omaha, Neb (Gamini S. Soori, MD); Meritcare Hospital CCOP, Fargo, ND (Preston D. Steen, MD); Altru Health Systems, Grand Forks, ND (Tudor Dentchev, MD); Ochsner CCOP, New Orleans, La (Carl G. Kardinal, MD); Saskatchewan Cancer Foundation (Muhammad Salim, MD); Sioux Community Cancer Consortium, Sioux Falls, SD (Loren K. Tschetter, MD); Rapid City Regional Oncology Program, Rapid City, SD (Richard C. Tenglin, MD); and Hematology and Oncology of Dayton, Inc., Dayton, Ohio (Howard M. Gross, MD).



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


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 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.


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. Cancer 2008. © 2008 American Cancer Society.