632. Chronic Myeloid Leukemia: Therapy: Clinical Trials and Outcomes


Conclusion cited from the abstract: 

HQP1351 was well tolerated and exhibited significant and durable antitumor activity in the patients with TKI-resistant CML, including those with T315I mutation. Two pivotal studies of HQP1351 in CML-CP and CML-AP patients with T315I mutation are ongoing in China.




Conclusion cited from the abstract: The combination of NIL + Peg-IFN seems to provide somewhat higher MR4.5 rates by M36 in newly diagnosed CP CML pts without inducing significant higher toxicities than NIL alone. Whether this will translate in higher TFR rates is under evaluation. Final updated results at M36 will be presented.



Conclusion cited from the abstract: This per protocol interim analysis demonstrates feasibility of the first-line treatment with NIL 2*300 mg/d combined with PEG-IFN 30-50 μg/week. Peg-IFN, when added upfront to NIL further increases the rates of MR4 and MR4.5, which may translate into higher rates oftreatment free remission.



*The study is being conducted on behalf of the German CML Study Group, the Swiss Group for Clinical Cancer Research (SAKK) and the East German Study Group on Hematology and Oncology (OSHO).



Conclusion cited from the abstract: A gradual dose increase, based on prospective molecular monitoring, allowed the great majority of enrolled patients (approximately 70%) to remain on treatment with BOS 300 mg OAD or less, achieving a major molecular response (MR3) in 60% of the cases. These results trial showed that, in elderly patients intolerant to or failing a first-line TKI, BOS may be highly effective and better tolerated at a dose lower than 500 mg OAD, namely at 300 mg OAD.



Conclusion cited from the abstract: We report the first prospective trial of ponatinib and conventional chemotherapy for blast phase CML. The EffTox model combined Phase I and II, and delivered efficiency in determining the trial’s optimal dose. This innovative statistical model has the potential to be applied in other rare malignancies. We confirm that FLAG-IDA + ponatinib 30mg, is a tolerable combination in blast phase CML, with promising response and survival. Post-transplant ponatinib was well tolerated and no excess toxicity was observed when ponatinib was used both pre- and post alloSCT. The combination of ponatinib and FLAG-IDA represents a potentially important advance in the treatment of blast phase CML, a rare complication which currently has a very poor outcome.



Conclusion cited from the abstract: 

This is the first, large, multicenter report focusing on treatment during pregnancy. Results suggest that CML patients can pursue a normal life including planning a family, with several caveats. Based on the different situations examined, treatment with IFN is confirmed safe. In contrast TKIs should not be used during pregnancy. Selected TKIs, specifically IM and NIL which have little placental transfer, can be started after organogenesis. Pts at onset can delay therapy without jeopardizing the future CML outcome. If therapy during pregnancy is deemed necessary, IFN can induce and maintain hematologic remission, or, if introduced earlier, preserve molecular remission after TKI interruption, while TKIs can reduce HTB. Caution should be taken when considering stopping TKI prior to conception due to the possibility of losing response, while an early stop (at first positive pregnancy test, 4-5 wk) could be considered. Detailed results, mother and child follow up and practical management will be presented.