ALBERT

Description: Background: The treatment of elderly or unfit patients with AML is disappointing with little improvement in the past 30 years. Studies in the 1960s (Clarkson, Cancer 1972) explored the use of prolonged low dose cytarabine (Ara-C) with frequent bone marrow monitoring until marrow hypoplasia. Treatment was given as long as needed with up to 6 weeks continuous therapy with some studies combining with synergistic thioguanine (TG). We developed a modification of the prolonged therapy concept using a 21 day course of low dose subcutaneous Ara-C with TG. Maintenance therapy with the same drugs was given for 2 yrs. Aim: To assess the safety and efficacy of low-dose sc cytarabine in combination with TG in patients with AML. Methods: Patients included (i) de novo AML, aged 〉 65, or unfit for intensive chemotherapy or (ii) patients 〉18 yrs with relapsed/refractory (R/R) AML. Patients received repeated administration of cycles of Ara-C 20mg/m2 s/c once daily with TG 40 mg/m2 PO once daily for 21 days. Bone marrow biopsy was performed within 4-7 days of completing the 21-day cycle and if blasts 〉 5% the next cycle was started immediately.There was no specified limit to the induction cycles which was at the investigators discretion considering patient tolerability. Once remission was achieved cycles were reduced to 14 days every 4-6 weeks for 2 years. Supportive care mandated posaconazole, ciprofloxacin, amoxycillin and pegfilgrastim 6 mg every 14 days continued until remission. Treatment was administered in an outpatient setting and Ara-C was given in the home by community nurses or local medical practitioners. The study was approved by the local hospital Human Ethics Committee and registered on the ANZ Clinical Trials Registry (ACTRN12617000231347). Results: Sixty patients were treated, Median age was 75 (range 72-94), 42 (70%) had de-novo AML and 18 (30%) R/R AML. Presenting WCC ranged from 0.8 to 185. Adverse cytogenetics were present in 40 (66%). In de-novo patients, 17 (40%) had prior haematologic disorders and 4 (10%) were treatment related. Response rates were: complete remission 40% or CR with incomplete count recovery (CRi) 28.5% in the entire cohort giving a response rate of CR+CRi of 68.5%. In the newly diagnosed group CR/CRi was 74%. Responses were also seen in the relapsed/refractory group with 5 of 18 (30%) achieving CR/CRi. The median number of cycles to achieve remission was 2 but some patients required up to 4 cycles. There were 9 (15%) deaths during induction. The median overall survival is 15 months in the de-novo group and 5 months in the relapsed/refractory group. A proportion of patients, 20-25% remain alive and in remission at 3 years post treatment. The main toxicity was as expected in this group of patients with infections predominating. No cases of severe liver toxicity were seen despite the prolonged use of thioguanine. Conclusion: Prolonged therapy with low dose Ara-C and TG can be given as an outpatient in elderly AML patients. Complete remission rates appear equal to or better than other commonly used protocols. Anthracyclines are not used. Toxicity was manageable and mainly neutropenia related but some patients never developed serious infections or required hospitalisation. We suggest that this concept of prolonged low dose cytotoxics with individual patient adjusted therapy based on bone marrow response has been overlooked since it was first proposed 40-50 years ago. Further studies are required to independently confirm these results. Disclosures No relevant conflicts of interest to declare.

Description: Background Readily accessible, smart-phone applications (Apps) have the potential to revolutionise and improve the delivery of patient care. Significant challenges associated with recruiting patients to haematology clinical trials include the rarity of diseases, complexity of trials, limited site locations, and maintaining knowledge of current trials in the context of rapid therapeutic developments. The Haematology Clinical Research Network, of New South Wales and the Australian Capital Territory (NSW/ACT) aimed to develop an App to facilitate clinician and patient access to current information on local clinical trials and improve trial participation by increasing referrals. Methods Key objectives were to develop an App that was free to download, simple to use and effective. Only publically listed data was to be included. Endpoints were rates of App usage, and cross-site and internal clinical trial referrals. Through liaison between the end-users (clinicians, trial managers and patients), and the contracted software developer, App specifications were refined through successive iterations. With the key search filters of Disease, Location, Sponsor and Study Status, the App has an easy to navigate listing of currently recruiting haematology trials. Useful features include: listing of inclusion and exclusion criteria; direct links to ClinTrials.gov; a lay summary; and direct contacts from the mobile device to participating study sites. Real-time data entry into the database app manager ensures currency of trial information. Results ClinTrial Refer went live in May 2013, on both iOS and Android platforms. As at 10th August, ClinTrial Refer has 654 users, over 4358 sessions and 13924 screen views.91% of current users are repeat users. Despite its local application the App has been accessed in 46 countries. Among the target audience in NSW 290 repeat users returned for an average 11 sessions each indicating a high user acceptance. It is being endorsed on the websites of Australian blood cancer consumer groups. A survey has confirmed that since its launch, through having readily accessible data on their smart-phones, ClinTrial Refer has increased clinician awareness of the NSW trial portfolio. In just twelve weeks it has resulted in the cross-referral of an additional 30+ patients for clinical trials, representing a 〉300% increase over previous referral patterns. This improvement in trials knowledge management has also increased within-site recruitment; however it is harder to quantify the exact short-term impact of ClinTrial Refer within hospitals. The App has already been duplicated for other Australian state-wide haematology networks and the Adolescent & Young Adult Research Network, NSW. Conclusion ClinTrial Refer is an innovative but simple, readily accessible mobile Application. Its widespread adoption across 18 Haematology Clinical Research sites in NSW Australia is facilitating increased patient recruitment to trials. Only recently available on iTunes and Google Play, it has attracted national and international attention as a template for any clinical trial network portfolio. Disclosures: Trotman: Celgene: Grant for App development Other. Huseincehajic:Celgene: Grant for App development Other.