NCCTG phase H trial of 2-chlorodeoxyadenosbse (2-CDA) as therapy for previously treated mantle cell lymphoma: Promising single agent activity limited by brief response duration

David J. Inwards, Rafael Fonseca, Paul J. Kurtin, Thomas M. Habermann, James Knost, David W. Hillman, Thomas E. Witzig

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Abstract

Mantle cell lymphoma (MCL) is a distinct subtype of lymphoma which typically presents in elderly men and is characterized by high stage at diagnosis, frequent extranodal sites of involvement, and a poor prognosis. We conducted a phase II trial of 2-CDA for therapy of MCL at 5 mg/m2/d IV × 5 days q 28 days for 2-6 cycles depending on response. Cases were stratified according to previous therapy. We reported an overall response rate of 81% as initial therapy (ASH 1999). This report includes only data from previously treated patients. Central pathology review to confirm MCL was required. Twenty-five previously treated patients were enrolled into the study, but 1 was subsequently deemed ineligible. The remaining 24 included 20 males and 4 females, median age 68 years (range: 39-81). Ann Arbor Stage was IV in 18 cases, and I or II in 6. Two or more extranodal sites were involved in 12 patients. Pretreatment LDH was elevated in 5 patients. The International Prognostic Factor Index (IPFI) was 0 in 2 cases, 1 in 4 cases, 2 in 9 cases, 3 in 4 cases, 4 in 4 cases and 5 in 1 case. The median number of previous regimens was 1 (1-6). Previous treatments included: anthracycline-containing regimens (15), rituximab (5), platinum-based regimens (1) and autologous stem cell transplant (1). Of the 20 patients with available response data from the last previous therapy, 11 (55%) had responsive disease. Five patients received 1 cycle, 8 received 2 cycles, 2 received 3 cycles, 4 received 4 cycles, and 5 received 6 cycles of 2-CDA. By NCCTG criteria, the complete response (CR) rate was 13% with a partial response (PR) rate of 33% and a minor response rate of 8% (total response rate 54%). By the current Cheson et. al. criteria 2 PRs would become CR or CRu for a CR/CRu rate of 21% and a PR rate of 25%. Following 2-CDA, the median time to progression was 5.4 months. The IPFI was not a predictor for time to progression and showed only a trend for prediction of overall response rates (66% for 0-2, 33% for 3-5; p=.ll). Eleven patients have died to date, 8 from progressive MCL, 1 from infection, 1 from a transplant-related complication, and 1 from unknown causes. Treatment complications included 1 grade 4 thrombocytopenia, 5 grade 4 neutropenias and 2 grade 4 infections. 2-CDA has significant activity as a single agent for the treatment of relapsed mantle cell lymphoma, though responses are of short duration. Subsequent trials will incorporate this active agent in combination with other agents.

Original languageEnglish (US)
Pages (from-to)139a
JournalBlood
Volume96
Issue number11 PART I
StatePublished - Dec 1 2000

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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