PMID- 31011660
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240210
IS  - 2451-8654 (Electronic)
IS  - 2451-8654 (Linking)
VI  - 14
DP  - 2019 Jun
TI  - Single arm phase II trial assessing the safety, compliance with and activity of 
      Bezafibrate and medroxyProgesterone acetate (BaP) therapy against myeloid and 
      lymphoid cancers.
PG  - 100361
LID - 10.1016/j.conctc.2019.100361 [doi]
LID - 100361
AB  - 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.
FAU - Murray, Jim
AU  - Murray J
AD  - Queen Elizabeth Hospital Birmingham, University Hospital Birmingham NHS 
      Foundation Trust, UK.
FAU - Pratt, Guy
AU  - Pratt G
AD  - Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, UK.
FAU - Jacob, Abe
AU  - Jacob A
AD  - New Cross Hospital, The Royal Wolverhampton Hospitals Trust, UK.
FAU - Clark, Fiona
AU  - Clark F
AD  - Worcestershire Royal Hospital, Worcestershire Acute Hospitals NHS Trust, UK.
FAU - Blundred, Rachel
AU  - Blundred R
AD  - Cancer Research UK Clinical Trials Unit, Birmingham, UK.
FAU - Fox, Sonia
AU  - Fox S
AD  - Cancer Research UK Clinical Trials Unit, Birmingham, UK.
FAU - Bishop, Rebecca
AU  - Bishop R
AD  - Cancer Research UK Clinical Trials Unit, Birmingham, UK.
FAU - Wheatley, Keith
AU  - Wheatley K
AD  - Cancer Research UK Clinical Trials Unit, Birmingham, UK.
FAU - Khanim, Farhat
AU  - Khanim F
AD  - School of Biosciences, University of Birmingham, UK.
FAU - Bunce, Chris
AU  - Bunce C
AD  - School of Biosciences, University of Birmingham, UK.
FAU - Drayson, Mark
AU  - Drayson M
AD  - Institute of Immunology and Immunotherapy, University of Birmingham, UK.
LA  - eng
GR  - 25354/CRUK_/Cancer Research UK/United Kingdom
PT  - Journal Article
DEP - 20190410
PL  - Netherlands
TA  - Contemp Clin Trials Commun
JT  - Contemporary clinical trials communications
JID - 101671157
PMC - PMC6463739
OTO - NOTNLM
OT  - Bezafibrate
OT  - Clinical trials
OT  - Lymphoid malignancies
OT  - Myeloid leukaemia
OT  - Progesterone
OT  - Therapy
EDAT- 2019/04/24 06:00
MHDA- 2019/04/24 06:01
PMCR- 2019/04/10
CRDT- 2019/04/24 06:00
PHST- 2019/01/16 00:00 [received]
PHST- 2019/03/20 00:00 [revised]
PHST- 2019/04/08 00:00 [accepted]
PHST- 2019/04/24 06:00 [entrez]
PHST- 2019/04/24 06:00 [pubmed]
PHST- 2019/04/24 06:01 [medline]
PHST- 2019/04/10 00:00 [pmc-release]
AID - S2451-8654(18)30184-4 [pii]
AID - 100361 [pii]
AID - 10.1016/j.conctc.2019.100361 [doi]
PST - epublish
SO  - Contemp Clin Trials Commun. 2019 Apr 10;14:100361. doi: 
      10.1016/j.conctc.2019.100361. eCollection 2019 Jun.