Single arm phase II trial assessing the safety, compliance with and activity of Bezafibrate and medroxyProgesterone acetate (BaP) therapy against myeloid and lymphoid cancers
| Autor: | Farhat L. Khanim, Rebecca Bishop, Christopher M. Bunce, Sonia Fox, Fiona Clark, Abe Jacob, Rachel Blundred, Guy Pratt, Mark T. Drayson, Jim Murray, Keith Wheatley |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Oncology
medicine.medical_specialty Myeloid medicine.medical_treatment Article 03 medical and health sciences 0302 clinical medicine Clinical trials Internal medicine hemic and lymphatic diseases medicine Medroxyprogesterone acetate 030212 general & internal medicine Progesterone Pharmacology lcsh:R5-920 Chemotherapy business.industry Myelodysplastic syndromes General Medicine medicine.disease R1 Lymphoid malignancies Lymphoma Clinical trial Haematopoiesis medicine.anatomical_structure Toxicity Myeloid leukaemia Therapy Bezafibrate lcsh:Medicine (General) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Contemporary Clinical Trials Communications Contemporary Clinical Trials Communications, Vol 14, Iss, Pp-(2019) |
| ISSN: | 2451-8654 |
| Popis: | We previously reported the safety and efficacy of low dose BaP [Bezafibrate (Bez) and Medroxyprogesterone acetate (MPA)] in 20 acute myeloid leukaemia (AML) patients for whom chemotherapy was not an option. This study provided evidence that BaP had anti-AML activity and improved haemopoiesis; absence of haematological toxicity allowed continuous daily administration. Similarly a previous trial in endemic Burkitt lymphoma demonstrated anti-B cell lymphoma activity of low and high dose BaP again in the absence of toxicity.We conducted a study to further evaluate the safety and activity of high dose BaP therapy in adults with AML (and high risk Myelodysplastic Syndromes (MDS)), chronic lymphocytic leukaemia (CLL) or B-cell Non-Hodgkin Lymphoma (BHNL). Eighteen patients were recruited to the study over 20 months, 16 AML/MDS, 1 CLL, and 1 BNHL. Although MPA was well tolerated throughout the study, only 2 patients were able to tolerate Bez treatment for their whole trial duration, indicating that Bez escalation is not feasible in the setting of adult AML/MDS. Thus there has been no obvious benefit in improved haemopoiesis or overt anti-leukaemia activity from the attempts to escalate BaP dose over previous published studies. Since current therapeutic options in MDS are restricted it may be now of value to continue to evaluate low dose BaP based approaches in low risk MDS rather than AML/high risk MDS. Furthermore, screening of low dose BaP against libraries of other already available dugs may identify an addition to BaP that augments the anti-neoplastic efficacy without significant toxicity. Keywords: Clinical trials, Myeloid leukaemia, Lymphoid malignancies, Therapy, Bezafibrate, Progesterone |
| Databáze: | OpenAIRE |
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