2-CHLORODESOXYADENOSINE - FIRST-LINE TREATMENT FOR LOW-GRADE NON-HODGKINS-LYMPHOMAS - A PHASE-II III STUDY OF THE ARBEITSGEMEINSCHAFT-MEDIKAMENTOSE-TUMORTHERAPIE/

Background: Treatment of advanced low-grade non-Hodgkin's lymphoma (NH L) remains palliative. For a good palliation a high remission rate wit h low toxicity is required. 2-Chlorodesoxyadenosine (2-CdA) is a new p urine analog with a toxic effect to resting and proliferating lymphocy tes. Phase II studies of 2-CdA in pretreated patients with low-grade N HL showed promising results. Interferon can prolong chemotherapy-induc ed remissions. Material and Methods: Endpoints of this trial are respo nse, survival, time to treatment failure, time to relapse, and toxicit y of Z-CdA induction and interferon-alpha-2c (IF) maintenance as first -line treatment in low-grade NHL. 2-CdA, 0.12 mg/kg body weight in 500 ml NaCl 0.9%, is given as a 2-hour infusion five times daily. Four cy cles are given in responding patients in 4-week intervals. After the 2 -CdA induction treatment, responding patients are put on maintenance t reatment with interferon-alpha-2c, 15 mu g subcutaneously 3 times week ly for 1 year. Results: Up to September 1, 1994, 13 patients were ente red, median age 52 years (range 35-74 years). All patients had stage I V disease. Ten patients had centroblastic-centrocytic histology, 3 had Waldenstrom macroglobulinemia. Six patients have finished their 2-CdA treatment. All patients had a remission, 4 had complete remission (CR ). After a median observation time of 7 months we observed 2 relapses. One patient died of lymphoma. One patient had a granulocyte nadir bel ow 1.0x10(9)/I, 2 had platelet counts below 100x10(9)/I. Four patients had infections, one of WHO grade 3. No other toxicities were observed . Conclusion: These results are encouraging; the study is open until 5 0 patients will have been entered.