¹Department of Hematology, Hôpital Edouard Herriot, Lyon, France

²Department of Hematology, Hôpital St Louis, Paris, France

³Department of Hematology, Hôpital Henri Mondor, Creteil, France

⁴Department of Hematology, Hôpital du Haut Levêque, Pessac, France

⁵Department of Hematology, Hôpital Beaujon, Clichy, France

⁶Department of Hematology, Hôpital de Brabois, Vandoeuvre, France

⁷Department of Hematology, Hôpital de l'Hôtel-Dieu, Paris, France

⁸Department of Hematology, Hôpital Jean Bernard, Poitiers, France

⁹Department of Hematology, Centre Henri Becquerel, Rouen, France

¹⁰Department of Hematology, Hôpital Lapeyronie, Montpellier, France

¹¹Department of Hematology, Hôpital de Hautepierre, Strasbourg, France

¹²Department of Hematology, Hôpital Jean Minjoz, Besançon, France

¹³Department of Hematology, Hôpital Georges Clémenceau, Caen, France

¹⁴Department of Hematology, Hôpital de l'Archet, Nice, France

¹⁵Department of Hematology, Centre Hospitalier Universitaire, Brest, France

¹⁶Department of Hematology, Hôpital Purpan, Toulouse, France

¹⁷Department of Hematology, Klinika Hematologie a Transfuziologie FN, Bratislava, Slovakia, France

¹⁸Department of Hematology, Hôpital de l'Hôtel-Dieu, Clermont-Ferrand, France

¹⁹Department of Hematology, Hôpital Necker-Enfants Malades, Paris, France

²⁰Department of Hematology, Hôpital d'Instruction des Armées Percy, Clamart, France

²¹Department of Hematology, Hôpital Robert Debré, Reims, France

²²Department of Hematology, Institut Gustave Roussy, Villejuif, France

²³Department of Hematology, Hôpital Claude Huriez, Lille, France

Correspondence to: X Thomas, Service d'Hématologie, Hôpital Edouard Herriot, F-69437 Lyon cedex 03, France; Fax: 33 4 72 11 74 04

The purpose of this study was to assess the safety and efficacy of stem cell transplantation (SCT) mainly autologous SCT as consolidation therapy in APL patients who relapsed and achieved a second complete remission (CR2). Fifty adult patients with a first relapsed APL, of whom 39 had been previously treated with ATRA, entered a multicenter trial of oral ATRA until complete remission (CR) achievement followed by timed sequential chemotherapy (EMA combining etoposide 200 mg/m²/day for 3 days, mitoxantrone 12 mg/m²/day for 3 days, and cytarabine 500 mg/m²/day for two sequences of 3 days). ema was started either after cr achievement, or on day 1 of atra because of initial white blood cell (wbc) counts >5 ´ 10⁹/l, or rapidly added to ATRA in order to prevent ATRA syndrome because WBC count increased under ATRA. Forty-five patients (90%, 95% CI 78%-97%) were in CR after induction therapy. Five patients died from infection during aplasia following EMA chemotherapy. Eleven patients who achieved CR had a familial HLA-identical donor and were allografted. The median disease-free survival (DFS) of allografted patients was 8.2 months. The 34 other CR patients were scheduled for autologous peripheral blood (PB) SCT (intent-to-treat group). Actually, autologous transplantation was only carried out in 22 patients (65%) (17 PBSCT and five autologous bone marrow transplantation (BMT)). Reasons for not autografting were early relapse (three patients), severe toxicity of EMA chemotherapy (six patients), and refusal or failure of stem cell harvest (three patients). The 3-year DFS rate of patients actually autografted was 77%. Among the 17 autografted patients still in CR2, nine patients have already reached a longer CR2 than first CR (CR1). Results of detection of PML/RAR by RT-PCR after autologous transplantation show negative findings in eight of the nine patients tested. We conclude that (1) ATRA combined to EMA chemotherapy is effective in the treatment of relapsed APL; (2) allogeneic BMT may be too toxic after salvage treatment including EMA intensive chemotherapy; (3) clinical outcome of autografted patients and preliminary molecular results regarding detection of PML/RAR after autologous PBSCT are encouraging. Leukemia (2000) 14, 1006-1013.

relapse; acute leukemia; acute promyelocytic leukemia; stem cell transplantation