Ethics approval and consent to participate
ICH
RECRUITMENT
This clinical study is conducted in accordance with ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences international ethical guidelines, and ICH good clinical practice (GCP) guidelines and applicable German laws and regulations. The trial has been approved by relevant competent authorities and an independent ethics committee and is registered at EudraCT (2016–004191-22).Data protection and confidentiality of personal data of participants are carried out in accordance with German Data Protection Regulation which is based on the European Basic Data Protection Regulation. Data protection is described in the informed consent form (ICF) accordingly.All study-related information will be stored securely at the study sites. All participant information will be stored in locked file cabinets in areas with limited access. All laboratory specimens, reports, data collection, process, and administrative forms will be identified by a coded ID (identification) number only to maintain participant confidentiality. All records that contain names or other personal identifiers, such as locator forms and informed consent forms, will be stored separately from study records identified by code number. All local databases will be secured with password-protected access systems. Participants’ study information will not be released outside the study without the written permission of the participant, except as necessary for monitoring by the sponsor’s clinical trial associates (CRAs) or the inspectors of the competent authority. Participants can obtain information about the collected data from sponsor of the study at any time.In accordance with the German drug law, patients that are enrolled into the study are covered by a patient insurance policy provided by the sponsor against negligent harm associated with the study protocol.The study will use a steering committee (SC). The SC consists of three representatives (PreCycle study investigators) of each of the cooperating study groups: AGO-B, AGO-Trafo, WSG, and DHGO as well as two representatives of the sponsor. The tasks are as follows: agreement of the final protocol and recruitment and liaising with principle investigator.The study will use a data monitoring committee (DMC). The DMC consist of three specialists in the fields of hematology/medical oncology as well as biostatistics. They are independent and therefore not involved in the PreCycle study as investigators. The DMC membership and governance is outlined in a separate charter. The DMC will be responsible for ongoing monitoring of the efficacy safety of patients under the study treatment and randomized PRO procedures.Measures to ensure and improve patient recruitment include:• Distribution of a PreCycle newsletter with important information for all centers on a regular basis;• Launching of a webpage • Amendments the protocol designed to improve the integration of CANKADO into clinical practice and• Inclusion of IOMEDICO as CRO, with good connections to private practice, to widen the spectrum of patients and different clinical settings.The treating physician is responsible for ensuring that all patients provide written informed consent prior to conducting any study-specific procedures. All questions will be addressed, and the informed consent form will be signed by the investigator.