scholarly journals Oral Arsenic Trioxide in the Frontline Treatment of Newly-Diagnosed Acute Promyelocytic Leukemia: A 5-Year Prospective Cohort Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3990-3990
Author(s):  
Harinder Gill ◽  
Cyrus R Kumana ◽  
Yok-Lam Kwong
Keyword(s):  
High Risk ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Conflicts Of Interest ◽  
Reference Value ◽  
Promyelocytic Leukemia ◽  
Newly Diagnosed ◽  
Frontline Treatment ◽  
Grade 3 ◽  
The Impact

Abstract Introduction and objectives Intravenous arsenic trioxide (As2O3) has been tested in the frontline treatment of newly-diagnosed acute promyelocytic leukemia (APL). We have formulated an oral preparation of As2O3 (oral-As2O3), and shown that it is efficacious for APL in when used in maintenance and re-induction protocol. In this study, we evaluated the use of oral-As2O3 in the frontline treatment of APL. The main objective of the study was to define the impact of upfront use of oral-As2O3 in newly-diagnosed patients. Methods Patients. Patients with newly-diagnosed APL in eight regional hospitals in Hong Kong were identified. Arsenic-induction cohort. Induction comprised oral-As2O3 (10 mg/day, reduced to 5 mg/day in patients with serum creatinine >upper reference value; as 1 mg/ml solution), ATRA (45 mg/m2/day in 2 divided doses) and ascorbic acid (1 g/day) (AAA regimen), administered for six weeks. Three days of daunorubicin (50 mg/m2/day) were administered to patients aged <70 years, and omitted for those aged ≥70 years. For patients not receiving daunorubicin, if the white blood cell count (WBC) rose to >5 x 109/L, hydroxyurea (2-3 g/day) was used for cytoreduction. Consolidation regimen. On confirmation of CR1, two monthly consolidations comprising daunorubicin (50 mg/m2/day x 2) and cytarabine (100 mg/m2/day x 5) were administered to patients aged <70 years. For patients aged ≥70 years, consolidation with two monthly cycles of AAA (2 weeks/cycle) was instead administered. Bone marrow examination was performed two weeks after completion of consolidation. Maintenance regimen. All patients received maintenance AAA, given two weeks every eight weeks for two years. Results In a 5-year period (January 1, 2013-March 31, 2018), there were 104 consecutive cases of newly-diagnosed APL. Five patients died at presentation due to disease complications. Arsenic-induction cohort. 62 newly-diagnosed patients (24 men, 38 women) at a median age of 52 (22-85) years, 36% having high-risk features, consented to and received oral-As2O3 induction. Complete remission (CR) rate was 100%. After a median of 29 (5-69) months, there were no relapses, so that conventional risks (age, leucocyte and platelet counts, FLT3 mutations) were not relevant. The leukemia-free survival (LFS) and overall survival (OS) at 3 years were both 100%. There was no leukemia- or treatment-related mortality. The most common non-hematologic AE was hepatotoxicity, presenting as transaminitis in all cases (grade 1/2, N=19, 30.6%; grade 3/4, N=16, 25.8%). Hyperbilirubinemia did not occur. In the sixteen cases with grade 3/4 transaminitis, oral-As2O3 was temporarily withheld for a median of 2 (1-5) days. With improvement in transaminases, oral-As2O3 was successfully re-administered without recurrence of transaminitis. Three patients developed QTc prolongation to a median maximum of 490 (480-496) ms. It was transient and self-limiting without need for oral-As2O3 dose interruption. Arrhythmias and heart failure were not observed. Headache, nausea and vomiting were other minor and less common AEs, which responded to symptomatic treatment. Non-arsenic-induction cohort. A contemporaneous cohort of 37 newly-diagnosed patients (15 men, 22 women; median age: 51, 23-78 years), 46% having high-risk features, did not consent to oral-As2O3 induction, and received similar induction (without oral-As2O3) and consolidation. CR rate was 100%. Most of them (89%) then received oral-As2O3 maintenance. After a median of 44 (6-69) months, there were three relapses (8%), all achieving remission again with oral-As2O3-containing salvage regimens. Arsenic induction versus non-arsenic induction. To define the role of oral-As2O3 during induction, we selected patients from the arsenic-induction cohort, who received daunorubicin induction, daunorubicin/cytarabine consolidation and AAA maintenance (N=50), and compared them with patients from the non-arsenic-induction cohort, who received the same induction, consolidation and AAA maintenance (N=32). The 5-year OS was comparable (arsenic-induction subgroup, 100% versus non-arsenic-induction subgroup, 96.8%; P=0.25). However, the 5-year LFS of the arsenic-induction subgroup was significantly superior to that of the non-arsenic-induction subgroup (100% versus 89.7%, P=0.04). Conclusion In conclusion, oral-As2O3 induction for newly-diagnosed APL was safe and reduced relapses. Disclosures No relevant conflicts of interest to declare.

scholarly journals Remission in Patients with Acute Promyelocytic Leukemia Treated with Arsenic Trioxide (varitrinox) As the First Line in Colombia

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 3-3
Author(s):  
Gustavo Milone ◽  
Samuel Sarmiento Doncel ◽  
Carol Agudelo Rico ◽  
Fabiola Vizcarra Reyes ◽  
Gina Alejandra Diaz Mosquera ◽  
...  
Keyword(s):  
High Risk ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Conflicts Of Interest ◽  
Promyelocytic Leukemia ◽  
Remission Induction ◽  
Intermediate Risk ◽  
Newly Diagnosed ◽  
First Line ◽  
Risk Patients

Acute promyelocytic leukemia (APL) is a subtype of Acute Myeloid Leukemia (AML) in which a chromosomal translocation t (15; 17) (q22; q12) is generated by fusing produces a hybrid PML / RARα gene, generating an altered signal . The combination of transretinoic acid (ATRA) plus arsenic trioxide (ATO) has been shown to be superior to ATRA plus chemotherapy in the treatment of newly diagnosed standard risk patients with acute promyelocytic leukemia (APL) in several countries. The objective of the present study is to describe the frequency of remission in patients with acute promyelocytic leukemia who were administered as a first line Arsenic Trioxide (varitrinox) during the period from November 2017 to June 2020 in Colombian patients. Methods: Retrospective observational and descriptive study of 12 patients diagnosed with acute promyelocytic leukemia treated with ATO Arsenic trioxide (Varitrinox) as first line, the source of information was provided by the treating hematologists (medical records) by filling out the technical concept format. Active pharmacovigilance scientist in Colombia, this format keeps the identification information of the patient anonymized and the confidentiality of the data is guaranteed as well as compliance with the rules of good clinical practice. Results: Twelve patients with age range between 22 and 69 years with a median age of 34.0 were analyzed. It was found in the analysis that 100% had induction hematologic remission with a median of 45 days. 75% of patients received ATO + ATRA and were at low and intermediate risk, the remaining 25% received ATRA + ATO + Chemotherapy and were at high risk, and intermediate risk. 91.7% of molecular remission in consolidation was obtained and it was measured in cycle 3 by means of PCR (undetectable), 8.3% (n = 1) was positive 3% and is finishing consolidation. Regarding the most frequent adverse events, intravascular coagulation (n = 9), neutropenia (n = 6) and thrombocytopenia (n = 6) were observed. 75% of patients are disease-free, 16.7% are on maintenance (they received ATO + ATRA + Induction chemotherapy) and 8.3% are on consolidation. So far, none of the patients under study have died. Conclusions: Our results support the use of ATO (Varitrinox) in newly diagnosed APL patients (as first line), as a care strategy for low, intermediate and high risk patients. The role of ATRA-ATO is guaranteed in other studies where they manage patients of different risks. Key words: Arsenic trioxide, leukemia promyelocytic acute, leukemia myeloid acute, remission induction, tretinoin. Disclosures No relevant conflicts of interest to declare.

Evaluation of Mechanisms of Resistance to Arsenic Trioxide In Patients with Acute Promyelocytic Leukemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2746-2746
Author(s):  
Ezhilarasi Chendamarai ◽  
Ansu Abu Alex ◽  
Saravanan Ganesh ◽  
Kavitha M Lakshmi ◽  
Sachin Jadhav ◽  
...  
Keyword(s):  
Gene Expression ◽  
Bone Marrow ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Promyelocytic Leukemia ◽  
Newly Diagnosed ◽  
Mechanisms Of Resistance ◽  
Induced Apoptosis ◽  
The Impact

Abstract Abstract 2746 Introduction: Newly diagnosed and relapsed acute promyelocytic leukemia (APL) patients respond to therapy with arsenic trioxide (ATO) based regimens. Significantly more patients with relapsed APL have disease recurrence after ATO based therapy than newly diagnosed cases. We undertook a series of experiments to evaluate the potential mechanisms to explain this increased recurrence rate in patients with relapsed APL. Patients and methods: From April 2007 to March 2009 bone marrow samples from newly diagnosed and relapsed cases admitted at our center were utilized for these studies. If required the bone marrow blasts and promyelocyte component was enriched to above 90% using a lineage depletion cocktail and VarioMACS (Miltenyi Biotec, Germany). For in-vitro intracellular ATO concentration measurement, 2 × 107 cells were washed and suspended in RPMI media with 0.5 μM concentration of ATO and incubated for 24 hours. Cells were then washed, made into a pellet and solubilized with HNO3 and H2O2 and ATO content measured using an atomic absorption spectrophotometer. An in-vitro sensitivity assay of malignant cells as previously reported was standardized using an MTT assay system. The impact of co-culture of mesenchymal stromal cells (MSC) and malignant promyelocytes on ATO induced apoptosis was studied with 7AAD and Annexin staining using a flowcytometer. A gene expression array using 44k human microarray chip analysis (Agilent technologies) was done on 8 newly diagnosed and 8 relapsed cases. Results: Sixty five patients were included in this study. Of these 47 (72%) were newly diagnosed and 18 (28%) were relapsed cases. On immunophenotyping, CD34 was positive (>20%) in 3.6% of newly diagnosed and 50% of relapsed cases (P=0.001). The mean MFI of the relapsed cases for expression of CD38, VLA-5 and CD13 was significantly lower in the relapsed group. The ability of both newly diagnosed and relapsed primary APL cells to concentrate ATO intracellular was not significantly different (15.2±9 nG/107 cell Vs. 16.3±9.7 nG/107 cell). Similarly the in-vitro IC-50 assay was not significantly different between the two groups (5.5±3.8 Vs. 4.7±4.5 μM). Neither of these assays correlate with clinical parameters such as relapse, event free (EFS) or overall survival (OS). Evaluation of the impact of MSC on ATO induced apoptosis demonstrates a protective effect in newly diagnosed and relapsed cases (Fig 1). This effect was mediated partly by the MSC conditioning media and could not be overcome by addition of VLA-4 or VLA-5 blocking antibodies (data not shown). Gene expression studies comparing the two cohorts revealed 1744 genes that were differentially expressed (>2 fold) between samples at diagnosis and at relapse. Quantitative Real-time RT-PCR using SYBR- Green detection system was done to confirm the gene expression results obtained from microarray analysis. Using ΔΔCT method the fold difference was calculated for five selected genes which validated the microarray data. Conclusion: Relapsed patients have significant immuno-phenotypic differences from newly diagnosed cases. Mechanisms of resistance to ATO are probably multi-factorial but are unlikely to be related to intra-cellular ATO concentration. In-vitro IC-50 does not appear to predict clinical outcomes. Stromal interaction protects malignant promyelocytes from the apoptotic action of ATO which appears more pronounced in relapsed than in newly diagnosed cases. Further evaluation of parameters that enhance such stromal interaction and protect malignant promyelocytes from the apoptotic effect of ATO along with evaluation of dysregulated genes and pathways are required. Disclosure: No relevant conflicts of interest to declare.

scholarly journals Oral Arsenic Trioxide in Front Line Therapy for Acute Promyelocytic Leukemia. A Prospective Costa Rican Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3838-3838 ◽  
Author(s):  
Mariela Rodriguez ◽  
Ronald Rojas ◽  
Alejandra Vargas ◽  
Miguel Angel Rodriguez ◽  
Claudia Garcia ◽  
...  
Keyword(s):  
High Risk ◽  
Complete Remission ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Oral Formulation ◽  
Promyelocytic Leukemia ◽  
Front Line ◽  
Line Therapy ◽  
Grade 3

KEY WORDS: Acute Promyelocytic Leukemia, oral Arsenic Trioxide, ATRA, Front Line Therapy. CONTEXT: Studies showed the combination of all-trans-retinoic acid (ATRA) with Arsenic trioxide (ATO) as an effective treatment of patients with newly diagnosed Acute Promyelocytic Leukemia (APL), permitting a chemotherapy-free treatment approach. Oral formulations of ATO were developed with similar efficacy compared to the IV formulation, and a slightly safer profile. OBJECTIVE:To determine the effectiveness and safety of a locally produced oral ATO with ATRA as a first line therapy in APL. DESIGN:We designed the LPCR05 protocol based on established treatment protocols. Treatment regimen: Induction phase: all patients received ATRA (45 mg/m2 daily) and an locally produced oral formulation of ATO (10 mg daily), with a dose of Idarubicin (12 mg/m2 on days 1,3,5 and 7, if older than 60 years only given on day 1) added only to the high-risk patients. Consolidation Phase: 3 cycles of ATO + ATRA for 30days every 6 weeks. Maintenance Phase: 4 Cycles of ATRA+ATO daily for 15 days every 3 months. Oral formulation for ATO is prepared by the Laboratory of Pharmaceutical Products from our Social Security System according to the literature and approved by local health and pharmaceutical regulators. RESULTS: We report data on our first 26 APL patients enrolled on the LPCR05 protocol. Six patients were classified as high risk, eighteen intermediate and two low risk (Table 1). One high risk patient discontinued after first consolidation because of lost follow up. The median follow up is 12.5 months. Hematological complete remission was obtained after 30 days of treatment in all 26 patients. Molecular complete remission in 22 evaluated patients after first and third consolidation was achieved in 95% and 100% respectively (Table 2). None of the patients have relapsed. There were no withdrawals of the protocol because of side effects and no induction deaths because of coagulopathy. No severe cardiac or neurological toxicity was found. Grade 3 hepatic toxicity was seen in two patients, in both cases, temporary discontinuation of ATRA and ATO resolved the side effect. One patient developed non treatment related grade 3 renal toxicity and other one developed a probably related grade 3 skin toxicity. Severe infectious complications were seen in three patients, two had pneumoniae (one death) and one enteritis (Table 3). Patients are managed in the ambulatory setting, with fewer hospitalizations (mean hospitalization days per patient of 38,1 with ATRA + chemotherapy vs 14,1 with oral ATO and ATRA), and therefore the cost is three times lower (US$65 208 vs US$24 195) than our previous approach with ATRA + chemotherapy protocol. CONCLUSION: Our data demonstrate both efficacy and safety of oral ATO with ATRA as front line therapy in all risk groups. This strategy also demonstrated lower operational costs, fewer hospitalization days, and improved convenience for patients. We expect longer follow-up will confirm that treatment with oral ATO and ATRA is a curative therapeutic strategy for patients with APL that is particularly attractive for use in low and medium income countries. Disclosures No relevant conflicts of interest to declare.

Treatment of Acute Promyelocytic Leukemia (APL) At Tawam Hospital UAE

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4347-4347
Author(s):  
Arif Alam ◽  
Harimohan Narayanan ◽  
Shanaaz Sonday ◽  
Sabir Hussain ◽  
Amar Lal ◽  
...  
Keyword(s):  
Retinoic Acid ◽  
High Risk ◽  
Supportive Care ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Conflicts Of Interest ◽  
Early Death ◽  
Promyelocytic Leukemia ◽  
Published Data ◽  
Female Ratio

Abstract Abstract 4347 Acute Promyelocytic Leukemia (APL) is a unique sub-type of Acute Myeloid leukemia associated with a balanced reciprocal translocation between chromosomes 15 and 17 and 80% of the cases present with bleeding diathesis caused by severe coagulopathy. The translocation generates a fusion transcript joining the PML(promyelocyte) and RAR-α (retinoic acid receptor-α) genes. The therapy of APL has been revolutionized by the introduction of differentiating agents All Trans Retinoic Acid (ATRA) and Arsenic Trioxide. All patients were treated as per Pethema protocol. Initially LPA99 (Sanz MA. Blood. 1999 Nov 1;94(9):3015-21) and since January 2012 a risk adapted therapy based on LPA2005 (Sanz MA et al. Blood June 24, 2010 vol. 115 no. 25 5137–5146). Treatment included induction followed by 3 cycles of consolidation and two years of maintenance. Nineteen patients were diagnosed with APL between January 2009 and June 2012. Three patients are excluded from the analysis as karyotyping and/or PCR did not confirm the diagnosis. The median age was 35 years (range 22–53 years). Male to female ratio was 4:1. Nine (56%) patients were stratified as high risk (WBC ≥ 10 ×109/l) while, seven (44%) as intermediate risk and low risk (WBC < 10 ×109/l). Three (19%) patients had early death despite treatment and supportive care. The cause of death was intracranial hemorrhage (1) pulmonary hemorrhage (1) and multi-organ failure (1). Thirteen patients achieved a complete morphological and molecular remission (80%). There has been only 1 case of treatment failure (high risk at presentation). This patient was successfully re-induced with arsenic trioxide and achieved second molecular complete remission. Unfortunately he relapsed a second time and is currently alive in third morphological remission but remains PCR positive for PML/RARα 33 months after diagnosis. Our limited experience shows favorable outcome (CR 80%) for the treatment of APL using the Pethema protocol compared to published data (Tallman MS. Blood 2002;99(3):759–767). Early death rate remains high despite intensive supportive care. The only variable is the availability and initiation of ATRA at the clinical suspicion of diagnosis both at the referring hospitals and treatment center. Disclosures: No relevant conflicts of interest to declare.

Studies on Treatment of Acute Promyelocytic Leukemia With Arsenic Trioxide: Remission Induction, Follow-Up, and Molecular Monitoring in 11 Newly Diagnosed and 47 Relapsed Acute Promyelocytic Leukemia Patients

Blood ◽  
1999 ◽  
Vol 94 (10) ◽  
pp. 3315-3324 ◽  
Author(s):  
Chao Niu ◽  
Hua Yan ◽  
Ting Yu ◽  
Hui-Ping Sun ◽  
Jian-Xiang Liu ◽  
...  
Keyword(s):  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Disease Free Survival ◽  
Promyelocytic Leukemia ◽  
Pcr Analysis ◽  
Remission Induction ◽  
Newly Diagnosed ◽  
First Choice ◽  
Wbc Count

Fifty-eight acute promyelocytic leukemia (APL) patients (11 newly diagnosed and 47 relapsed) were studied for arsenic trioxide (As2O3) treatment. Clinical complete remission (CR) was obtained in 8 of 11 (72.7%) newly diagnosed cases. However, As2O3 treatment resulted in hepatic toxicity in 7 cases including 2 deaths, in contrast to the mild liver dysfunction in one third of the relapsed patients. Forty of forty-seven (85.1%) relapsed patients achieved CR. Two of three nonresponders showed clonal evolution at relapse, with disappearance of t(15;17) and PML-RAR fusion gene in 1 and shift to a dominant AML-1-ETO population in another, suggesting a correlation between PML-RAR expression and therapeutic response. In a follow-up of 33 relapsed cases over 7 to 48 months, the estimated disease-free survival (DFS) rates for 1 and 2 years were 63.6% and 41.6%, respectively, and the actual median DFS was 17 months. Patients with white blood cell (WBC) count below 10 × 109/L at relapse had better survival than those with WBC count over 10 × 109/L (P = .038). The duration of As2O3-induced CR was related to postremission therapy, because there was only 2 of 11 relapses in patients treated with As2O3 combined with chemotherapy, compared with 12 of 18 relapses with As2O3 alone (P = .01). Reverse transcription polymerase chain reaction (RT-PCR) analysis in both newly diagnosed and relapsed groups showed long-term use of As2O3 could lead to a molecular remission in some patients. We thus recommend that ATRA be used as first choice for remission induction in newly diagnosed APL cases, whereas As2O3 can be either used as a rescue for relapsed cases or included into multidrug consolidation/maintenance clinical trials.

Single Agent Arsenic Trioxide Regimen for the Treatment of Newly Diagnosed Acute Promyelocytic Leukemia: Initial Results of a Multicenter Randomized Controlled Study From India to Study the Optimal Duration of Arsenic Trioxide Maintenance Therapy (IAPLSG04).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2082-2082 ◽  
Author(s):  
Vikram Mathews ◽  
Biju George ◽  
Farah Jijina ◽  
Cecil Ross ◽  
Reena Nair ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Single Agent ◽  
Promyelocytic Leukemia ◽  
Controlled Study ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Short Period

Abstract Abstract 2082 Poster Board II-59 Single agent arsenic trioxide (ATO) has proven efficacy in the management of newly diagnosed cases of acute promyelocytic leukemia (APL). To validate findings of an initial single center experience (Blood 2006:107; 2627) with this low cost, well tolerated, effective regimen, a multicenter study was undertaken in a resource constrained environment. Additionally, in an effort to improve on the earlier experience and study the role of duration of maintenance on reducing late relapses, patients were randomized to 6 vs. 12 months of ATO maintenance (ClinicalTrials.gov Identifier:NCT00517712). From July, 2004 to December, 2008, 182 patients were initially screened and enrolled based on morphological diagnosis of APL from 7 centers in India. Diagnosis was subsequently confirmed by molecular methods. Twenty seven cases were excluded from analysis (6 RT-PCR negative, 4 IC bleed at diagnosis, 5 septic/pneumonia at diagnosis, 9 withdrew consent prior to randomization and some were treated with other protocols, 1 withdrawn by investigator prior to randomization). Patients were treated with single agent ATO at standard doses (10mg/day for adults and 0.15mg/kg/day for pediatric patients) for up to 60 days in induction; this was followed by a 28 day consolidation after a 4 week break. Four weeks after completion of consolidation patients who were in molecular remission were randomized to 6 vs. 12 months of maintenance therapy with ATO administered for 10 days/month. Hydroxyurea was permitted for control of leucocytosis. Anthracyclines were permitted in induction for patients presenting with or WBC count rising >20×109/L in the first week, >50×109/L in the second week and for those who developed a differentiation syndrome. Of the 155 patients who could be evaluated 136 (87.7%) achieved hematological remission (CHR). One patient had primary induction failure and was removed from the study while the other 18 were induction deaths at a median of 17 days (range: 4 – 69). During induction, 52 (33.5%) patients received an anthracycline and 116 (75%) received hydroxyurea. A differentiation syndrome was documented in 25 (16%) cases and was fatal in one. Grade III/IV non hematological toxicity was seen in 26 (16.7%), which resolved in the majority after discontinuing ATO for a short period. One hundred and thirty six patients were randomized, 64 (47%) and 72 (53%) into a 6 and 12 month maintenance regimen respectively. A protocol change after randomization was done in 3 cases for persistent toxicity. Five (3.6%) patients did not complete the scheduled maintenance regimen due to poor compliance or was discontinued by the investigator. At a median follow up of 24 months, the 3-year Kaplan-Meir estimate of overall survival (OS), event free survival (EFS) and disease free survival (DFS) of the entire cohort was 76.87±4.33%, 71.57±4.64% and 80.69±4.77% respectively. Fourteen patients relapsed, the median time to relapse was 19.3 months (range: 9-51). The baseline characteristics of the two groups (6vs12 months) were not significantly different. Post randomization, the two groups were analyzed on an intention to treat basis. The OS, EFS and DFS of the two groups were not statistically significantly different. There was also no evidence that the group that received 12 months of maintenance had any increased incidence of toxicity. Single agent ATO based regimen as reported previously is well tolerated and results in durable remissions. Longer follow up is required to see if 12 months of maintenance therapy reduces risk of late relapses. Disclosures: No relevant conflicts of interest to declare.

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