Introduction: Glivec, Imatinib (IM), first tyrosine kinase inhibitor (TKI) has proven its efficacy and safety in Chronic Myeloid Leukemia - Chronic Phase (CML CP) in a large number of trials. In developing country like India Generic Imatinib formulations have been used recently as a more cost effective treatment, data on efficacy and safety of these drugs is sparse. Aim: To analyse and compare safety profile, the overall survival (OS) and progression-free survival (PFS) data of CML-CP patients receiving Glivec/Generic IM as first line therapy Method: A single centre retrospective analysis done on CML-CP patients who initiated treatment with either Glivec or Generic IM between July 2012 and July 2019 at Hemato-oncology Care Centre (HOCC) Vadodara India. Total 109 newly diagnosed CML-CP received IM as 400mg daily dose, dose was adjusted if significant cytopenia observed or in paediatric patients. Response assessment was made as per NCCN CML Version 1 2019 guidelines.Molecular monitoring of patients was done through BCR-ABL1 RQPCR, reported on international scale. Major Molecular Response (MMR) was considered when the ratio on international scale was less than 0.1% level or ≥ 3-log reduction in BCR-ABL1 mRNA from the standardized baseline, while Deep Molecular Response-MR4 was considered when the ratio on international scale was less than 0.01%.OS was measured from starting date of IM until to the date of death from any cause while on therapy or last seen.PFS was measured from starting date of IM to transformation to AP or BC or deaths while on therapy. Survival curves were calculated by the Kaplan-Meier method and compared with the log-rank test. Cox regression with Backward Wald Method, Chi-square test and t-test is applied using SPSS software version 21.0. A p-value <0.05 is considered to be statistically significant. Results: A Total 109 patients were analysed, received Glivec (47)43% or Generic IM (62)56%. The mean (SD) age was 42.2 years (13.3 years) in Glivec and 47.5 years (14.9 years) in the Generic IM group (P=0.06). There was male preponderance in both groups (Glivec 55%, Generic IM 62 %). Sokal score stratification in Glivec and Generic groups, was respectively: low risk 43%/40%; intermediate risk 36%/48% and high risk 21%/11% (P=0.08). The median follow‐up period was 36 months (range, 9-84). MMR was 61% and 38% in Glivec and Generic IM respectively(p=0.02), MMR was achieved in 40%,04%,11%,06% of Glivec and 29%,2%,5%,2% of Generic IM group patients, at 1st,2nd,3rd,4th year of treatment respectively(P=0.15).Deep Molecular Response-MR4 was significantly higher 40% in Glivec vs 23% in Generic IM group (P=0.01). Nearly 35% of patients were lost to follow up, 28% and 40% in Glivec and Generic IM group respectively(p=0.27). Reasons for drop out were - cost constraints, noncompliance, lack of understanding, lack of transport. Dose limiting cytopenia was observed in initial 3 months of treatment in 12% and 23 % in Glivec and Generic IM group respectively(P=0.28).The most common non haematological side effects in Glivec and Generic groups were skin hyperpigmentation 19%,17%, abdominal discomfort 16 %,11% ,Facial Puffiness 9%,5%, respectively(P =0.73). In each group 4% patients progressed to AP, managed with second generation TKI in Generic IM group and with increasing dose of Glivec to 600mg daily in Glivec group. Total 5% patients progressed to BC and died, 3% in Glivec vs 2% in Generic IM group. The risk factors for progression to AP or BC were high Sokal score, poor molecular response and dose limiting cytopenia. OS and PFS at 36 months were similar in Glivec and Generic IM (93.6% vs. 96.8% P=0.834) and (89.4% vs. 91.9%, P=0.839) respectively. Conclusion: Both the groups have shown similar OS and PFS at 36 months of median follow up, there was also no difference in the safety profile, meeting Generic IM unmet needs in developing country. However in view of higher MMR and Deep molecular response-MR4 in Glivec group, need long term follow up to determine its impact on outcome especially in reference to treatment free remission. Figure Disclosures No relevant conflicts of interest to declare.

Introduction: Thrombopoietin receptor agonist (TPO RA) is an approved second line of treatment in Persistent and Chronic Immune Thrombocytopenic Purpura (ITP).However in India due to cost constraints, the majority prefer Immunosuppression therapy. A biosimilar of Romiplostim (Romy®) is developed and launched in India, by Intas Pharmaceuticals, India, in July 2019, its monthly cost is around $160, a huge relief to ITP patients (pts), now accessible to the masses in Lower Middle Income Country (LMIC), India. Real-world experience data on Romiplostim (Romy®) in ITP is sparse. Aim: A single centre retrospective data analysis to evaluate the Safety and Efficacy of Biosimilar Romiplostim (Romy®) in patients of Immune Thrombocytopenic Purpura. Method: A total of 54 steroid-refractory or steroid-dependent ITP pts were registered at Haemato-oncology Care Centre Vadodara from July 2019 to January 2020, who received Injection Romiplostim (Romy®) treatment. Pre-treatment Complete Blood Count(CBC) Platelet count (PLT) ,Liver Function Test ,Renal Function Tests ,PT,PTT,ANA,HIV,HBsAg,HCV,Bone Marrow,USG Abdomen, Chest X-Ray was done.All patients had pretreatment Platelet count less than 30000/cumm.The dose of Romiplostim was 1mcg /kg to 6 mcg/kg, subcutaneous once a week.12 /54 patients who had active bleeding also received concomitant Rituximab 100mg IV infusion once a week for 4 weeks. The response was assessed by CBC PLT every week for the first 4 weeks, later on, every monthly. The response was labelled as Optimum if PLT count maintained between 50000/cumm to 4,00,000/cumm, Suboptimal if PLT count increased from baseline but remained below 50,000/cumm, No response if no increment from baseline PLT count. Romiplostim was continued with the same dose if response was Optimum, escalated if response was Suboptimal, de-escalated if PLT increased above 1, 50,000/cumm and stopped if PLT increased above 4,00,000/cumm or no response found after 4 weeks of treatment. Results: Atotal of 54 pts were evaluated, 23(42%) Male, 31(58%) Female, Median age 40 years (range 8 yrs to 85yrs).Persistent ITP was the diagnosis in 38/54(70%)pts, Chronic ITP in 16/54(30%) pts, Secondary ITP in 17(30%) pts, with 14 patients had ANA positive, 2 patients had HCV positive, 1 patient had tubercular lymphadenopathy. The overall response rate (ORR) was 50/54(93%).Optimum response in 49 /54 (91%),Suboptimal response in 1/54 (2%),No response in 4/54(7%)pts. ORR in patients who received Rituximab with Romiplostim was 12/12 (100%). Time to achieve response was 1 week in 46 (85%) pts, 2 weeks in 3(5%) pts, and 3 weeks in 1 (2%) pts. Follow up assessment showed a total of 21/54 (40%) patients had sustained optimum response for more than 6 months with continuation of once a week Romiplostim,9/54 (16%) had sustained response for more than 6 months even on discontinuation of Romiplostim after 4 weeks.8/54(15%) pts with ANA positive reports required a combination of immunosuppressant with Romiplostim to maintain prolonged sustained response.4/54(7%) pts did not respond to Romiplostim hence it was stopped after 4 weeks. Mild adverse effects were observed headache 5(9%), myalgia 3 (5%), bone pains 6(11) Abdominal pain 4(7%) pts. Romiplostim was stopped in 12 (22%) pts because of thrombocytosis (PLT above 4, 50,000/cumm) after a first single dose of Romiplostim. None of the patients had serious adverse events Conclusion: Biosimilar Romiplostim, (Romy®) has shown rapid, excellent and sustained response in the majority of ITP pts in our study. Its affordable cost fulfils an unmet need of ITP patients, requiring the best second line of treatment in LMIC Disclosures No relevant conflicts of interest to declare.

Background: Pancytopenia is one of the common laboratory findings in patients presenting to us with varied clinical presentations. Risks of untreated Pancytopenia are high causing anxiety to treating doctors and patients alike. It also involves long list of investigations including a very painful marrow biopsy, life-threatening complications and treatment involves multiple blood component therapy. A total of 101 cases of pancytopenia over a period of 1 year were analysed retrospectively to find i) commonest presenting symptoms ii) commonest cause of pancytopenia, response to treatment iii) Depending on the cause, to consider if any measures can be taken for preventionMethods: Cross sectional study of 101 admitted patients of Pancytopenia on the basis of information extracted from the case sheets. The data was analyzed and presented as frequencies and Percentages.Results: Out of 101 cases analysed, 53 (52.47%) were females 48 (47.52%) patients males. Fatigue 74 patients (73.2%) was the commonest presenting symptom followed by fever 33 (32.6%), breathlessness 13 (12.87%) and bleeding 4(3.8%). Vitamin B12 deficiency 58 (57.6%) patients showed and was the commonest cause of pancytopenia. Infections in 24 (23.7%) like malaria16 (15.6%), dengue 5 (4.96%), PLHA 1(0.96%) and hepatitis B 2 (1.96%) was the second common cause in present study. Recovery of pancytopenia was prompt in Malaria Dengue. HIV, Hepatitis B viral infection showed persistent pancytopenia with hypoplastic marrow. Chronic liver disease portal hypertension splenomegaly accounted for 9 (8.9%) patients. Drug induced marrow suppression due to ongoing treatment for underling disease resulted in pancytopenia in 4 (3.96%) patients. Aplastic anaemia in3 (2.9%), myelodysplastic syndrome 2 (1.9%) and acute leukaemia 1 (0.96%) were the less common causes.Conclusions: Commonest symptom on presentation were related more to anaemia than to neutropenia and thrombocytopenia. megaloblastic anaemia due to Vitamin B12 deficiency was the leading reversible cause of pancytopenia in present study followed by infections like Malaria Dengue. Gujarat, India being predominantly vegetarian state, local dietary habits are thought to be responsible for inadequate B12 daily consumption, hence we suggest fortifying the daily diet with B12 supplementation at a larger scale just like iodisation of salt to counter iodine deficiency.

Introduction: Sickle cell disease (SCD) poses a considerable health burden in lower middle income country (LMIC) like India. One ICMR survey reported about 20% of children with SCD died by the age of two years and 30% of children with SCD amongst the tribal community in India died before they reached adulthood. Data on mortality rate in the adult population with SCD is sparse. Our centre data shows that despite the availability of Hydroxyurea and supportive care, almost one-third of hospitalized Sickle Cell Crisis patients develop life threatening complications. Manual Partial Exchange Transfusion is a cost-effective intervention to decrease mortality in Sickle Cell Crisis. But perhaps, it is an underutilized therapy. In India, the cost incurred for each session of exchange transfusion, if done by the RBC apheresis machine, is $420. Whereas Manual Exchange Transfusion costs only $70(including the cost of the central venous catheter) for the first session followed by $15 for each subsequent session. Aim: A single centre retrospective data analysis to evaluate the outcome of Sickle Cell Crisis patients undergoing Manual Partial Exchange Transfusion during hospitalization. Material and Method: A total of 553 SCD patients on regular follow up at the Haemato Oncology Care Centre (HOCC) from July 2012 to July 2020 were evaluated.169 patients were hospitalized for treatment of Sickle Cell Crisis at the Bhailal Amin General Hospital and Sterling Hospital Vadodara. The data was retrieved after the IRB/Apex committee approvals for retrospective analysis. The indication for exchange transfusion was Acute Chest Syndrome 19(35%), Hepatic cell crisis 11(20%), Vaso Occlusive Crisis not responding to the conservative line of therapy in 48 hours of treatment 11(20%), Cerebrovascular Accident (CVA) 5 (9%), Avascular Necrosis of Femur with excruciating pain 3 (6%), Complicated Dengue with Multi-organ failure 3 (6 %), Priapism 1 (2%) and Splenic Sequestration 1 (2%). Central venous access was secured with a central venous catheter or dialysis catheter. Simple packed cell volume was transfused to 11(20%) patients and 5(9%) patients received platelet transfusion. The cut-off values for HB and Platelet count were 8 gm% and 50000/cumm, respectively at the time of the Manual Partial Exchange Transfusion procedure. Blood volume withdrawn was 5 to 10 ml /kg, followed by an equal volume of packed cell volume transfusion at every session. The procedure was repeated every 12 hr or 24 hr depending on the clinical condition of the patient. HbS value was reassessed post 4 sessions with repeat testing done after 2 to 4 sessions if the observed HbS value was more than 30% or more than 10% (for CVA) after 4 sessions. The endpoint was clinical recovery with HbS less than 30% or no clinical recovery despite the achievement of HbS less than 10%. In CVA the endpoint was HBS less than 10%. Results: Manual Partial Exchange Transfusion was carried out in 54/169 (32 %) hospitalized patients. The median age was 25yrs (range 5 yrs to 69 yrs), with male predominance [Males 42(77%) and females 12(23%)].Pre procedure HbF value was &lt;10% in 13(24%), 10 to 20% in 23 (43%) and &gt;20% in 18(33%). A total of 50 out of 54 (93%) patients recovered completely. 28 (52%) patients were hemodynamically stable with normal SPO2 on room air at the time of Manual Partial Exchange Transfusion with an average of 7 days of hospitalization. All of these patients recovered completely with less than 5 sessions of Manual Partial Exchange Transfusion. 26(49%) patients were critically ill and had an average of 12 days of hospitalization. They were on Ventilator and Inotrope support at the time of Manual Partial Exchange Transfusion. 14/26(54%) critically ill patients recovered completely with an average of 6 sessions of Manual Partial Exchange Transfusion. 12/26(46%) critically ill patients succumbed even though post exchange HBS value decreased to less than 10%. The overall mortality rate of SCD patients in this analysis was 12/553 (2.1%), significantly lower than what was historically reported as 30% in the ICMR survey. Underlying Dengue viral infection associated with Multi-organ dysfunction and Fulminant hepatic failure were risk factors for mortality observed in our study. Conclusion: Manual Partial Exchange Transfusion is highly effective in reducing mortality in Sickle Cell Crisis. It is feasible and cost-effective in small centres lacking apheresis machine facility. Disclosures No relevant conflicts of interest to declare.