Completed Clinical Trials

The QOL-ONE Association develops and manages Multicenter National and International Clinical Trials to evaluate new treatments for patients with hematologic diseases. The clinical objectives of the studies include efficacy – in terms of response to treatment, survival and patient’s subjective measure (quality of life and symptoms -Patient Reported Outcomes) – and safety (assessment of adverse events associated with treatments). 

QOL-ONE also performs observational and translational studies. Further, it develops new instruments for the evaluation of patient-reported outcomes in hematological patients.

The trials and projects involve hematologists, patients and advocacy groups throughout the world.

QOL-ONE is technically supported by Dielnet s.r.l.  (Contract Reasearch Organization)

Completed Clinical Trials

QOL-ONE Rev2MDS “Efficacy of eltrombopag plus lenalidomide combination therapy in patients with IPSS low and intermediate-risk myelodysplastic syndrome with isolated del5q: a multicenter, randomized, double-blind, placebo controlled study”. (Eudract number 2015-000362-53)

The aim of the clinical trial is to evaluate  of the experimentation is the efficacy and safety of  Eltrombopag for the treatment of thrombocytopenia in the patients taking lenalidomide for MDS treatment with isolated del5q. The primary objective is assess the results of the Eltrombpag treatment for thrombocytopenia and hemorrhagic events in the experimental arm versus the placebo controlled arm.

Beside will be compared in the two arms the adverse events, cytogenetic responses, Hb changes, erythroid response, transfusion-independence, overall survival and quality of life.

QOL-AML-E” QOL-ONE supported the observational study together with the Italian Association against leukemia-lymphoma and myeloma (AIL).

Objective of the study was to evaluate the changes in the quality of life of elderly patients with acute myeloid leukemia,  associated with the disease and its treatments.

The prognostic value of QOL from diagnosis  for survival derived from this clinical study was published in the following  international journal: Oliva EN, Nobile F., Alimena G., et al. Quality of life in elderly patients with acute myeloid leukemia: patients may be more accurate than physicians. Haematologica 2011 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3084916,

Qol-ESC RevMDS“, phase II, multicenter, single-arm study.  (Eudract number 2008-000547-34)

The aim of the  clinical trial was to evaluate the efficacy of lenalidomide treatment in adult patients with anemia due to a low or intermediate risk of Mielodisplastic Syndrome with cytogenetic abnormal short arm delation  of chromosome 5.

In addition to the evaluation of hematologic, cytogenetic and molecular response and toxicity, the response to the  quality of life was evaluated.

For the study results,  see the following publications:  

Oliva EN, Cuzzola M., Nobile F., et al. Changes in RPS14 expression levels during lenalidomide treatment in Low-and Intermediate-1-risk Myelodysplastic. European Journal Of Haematology 85(3):231-5 • September 2010
https://www.ncbi.nlm.nih.gov/pubmed/20491881,

Oliva EN., Cuzzola M., Aloe Spiriti MA, et al., Biological Activity of lenalidomide in myelodysplastic sindromes with del5q: results of gene expression profiling from a multicenter phase II study. Ann Hematol.  2012 Sep 16. https://link.springer.com/article/10.1007/s00277-012-1569-0,

Oliva EN., Latagliata R., Laganà C., et al. Lenalidomide in Low-and Intermediate-1 IPSS risk myelodysplastic syndromes with del(5q): an Italian phase II trial of health-related quality of life, safety, and afficacy. Leuk Lymphoma. 2013 Feb 25. https://www.ncbi.nlm.nih.gov/pubmed/23432724,