Last updated on August 2018

hATG+CsA vs hATG+CsA+Eltrombopag for SAA


Brief description of study

The null hypothesis of no difference in CR% at 3 months between the arms will be tested against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds ratio for arm yielded by this model.

Detailed Study Description

This is a superiority trial aiming to increase the 3 month complete response rate. The sample size is calculated on the hypothesis that the experimental treatment will increase the 3 months response rate up to 21% (by 3 folds, based on the 7% reported in Scheinberg et al [17]). Under these assumptions, the sample size to reject the null hypothesis is n=96 patients for each treatment arm, increased by 4% for possibly not evaluable patients (total number of 200 patients, 100 each treatment arm). Statistical design for sample size calculation: increase from 7% (control arm) to 21% (investigational arm) in 3 month complete response rate (two-sided binomial test); alpha-error 0.05; power 0.8.

Clinical Study Identifier: NCT02099747

Contact Investigators or Research Sites near you

Start Over

Eric Deconinck, Prof, MD

Hopital Jean Minjoz
Besancon, France
  Connect »

Reza Tabrizi, MD, PhD

H pital Haut-L v que
Bordeaux, France
  Connect »

Louis Terriou, Prof, MD

H pital Huriez
Lille, France
  Connect »

Fiorenza Barraco, MD

Centre Hospitalier Lyon-Sud
Lyon, France
  Connect »

Regis Peffault de la Tour, ...

St. Louis Hospital
Paris, France
  Connect »

Christian Recher, Prof, MD.

H pital Purpan
Toulouse, France
  Connect »

Sofie Terwel, MSc

Uniklinik RWTH Aachen
Aachen, Germany
  Connect »

Sofie Terwel, MSc

Universitatsklinikum Essen
Essen, Germany
  Connect »

Sofie Terwel, MSc

Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
  Connect »

Sofie Terwel, MSc

Hannover Medical School
Hannover, Germany
  Connect »

Sofie Terwel, MSc

University of Ulm
Ulm, Germany
  Connect »

Alessandro Rambaldi, Prof, MD

Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
  Connect »

Carlo Dufou, Prof, MD

Istituto G. Gaslini children's Hospital
Genova, Italy
  Connect »

Maria-Theresa van Lint, MD

San Martino Hospital
Genova, Italy
  Connect »

Wilma Barcelini, MD

Fondazione IRCCS ca Granda Ospedale
Milan, Italy
  Connect »

Roberto Foa, Prof, MD

La Sapienza University Hospital
Rome, Italy
  Connect »

Sacha Zeerleder, MD, PhD

AMC
Amsterdam, Netherlands
  Connect »

Marco de Groot, MD, PhD

UMCG
Groningen, Netherlands
  Connect »

Stijn Halkes, MD, PhD

Leiden University Medical Center
Leiden, Netherlands
  Connect »

Reinier Raijmakers, MD, PhD

UMCU
Utrecht, Netherlands
  Connect »

Blanca Xicoy, MD

Hospital Universitari Germans Trias I Pujol
Badalona, Spain
  Connect »

Sofie Terwel, MSc

Hospital Clinico San Carlos
Madrid, Spain
  Connect »

Sofie Terwel, MSc

Hospital Virgen de la Victoria
Malaga, Spain
  Connect »

Carlos Vallejo, MD, PhD

Donostia Hospital
San Sebastian, Spain
  Connect »

Isidro Jarque Ramos, MD, PhD

Hospital La Fe
Valencia, Spain
  Connect »

Dominik Heim, MD, PhD

University Hospital Basel
Basel, Switzerland
  Connect »

Sofie Terwel, MSc

City Hospital
Belfast, United Kingdom
  Connect »

Anita Hill, MD, PhD

St. James Hospital
Leeds, United Kingdom
  Connect »

Judith Marsh, Prof, MD

King's College Hospital
London, United Kingdom
  Connect »

Jamie Cavenagh

St. Bartholomew's Hospital
London, United Kingdom
  Connect »

Nigel Russell, Prof, MD

City Hospital
Nottingham, United Kingdom
  Connect »

Sofie Terwel, MSc

Institut Paoli Calmettes
Marseille, France
  Connect »

Roche Houot, MD, PhD

Pontchaillou Hospital
Rennes, France
  Connect »

Sofie Terwel, MSc

Ospedale San Raffaele
Milan, Italy
  Connect »

Antonio Risitano, MD, PhD

`Federico II` Medical School
Naples, Italy
  Connect »

Sofie Terwel, MSc

Policlinico Gemelli
Rome, Italy
  Connect »

Foberto Foa, MD

AOU Citt della Salute e della Scienza di Torino
Turin, Italy
  Connect »

Isabel Sánchez-Ortega, MD, PhD

Institut Catal d'Oncologia - Hospital Duran i Reynals
Barcelona, Spain
  Connect »

Alicia Rovo, MD

University Hospital Bern
Bern, Switzerland
  Connect »

Markus Manz, Prof. MD

University Hospital Z rich
Zürich, Switzerland
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.