BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol
Sponsor: Anne Louise Tølbøll Sørensen
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall survival
Time frame: OS is defined as the time from randomization until the time of death due to any cause, assessed up to 5 years.
Secondary Endpoints
Progression free survival
Patient-reported health-related quality of life
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v6.0
Eligibility Criteria
Inclusion Criteria: * Participants of any sex who are at least 18 years of age at the time of providing informed consent. * Participant diagnosed with a haematological disease, i.e. any disorder that primarily affects the blood, bone marrow, the lymphatic system and/or blood-forming organs. * Should be eligible for participation in at least one of the currently active domains. * Capable of giving signed informed consent for each applicable DSA(s). By consenting to a domain, participants also consent to participation in BLOOD-dose. Exclusion Criteria: * The participant tient is expected to live less than 3 months, as judged by the investigator. * Any condition that, in the opinion of the investigator, impairs the participant's ability to understand trial procedures, provide informed consent and/or interfere with participation and/or compliance in the trial. Domain eligibility criteria: each domain has its own specific eligibility criteria detailed in each DSA.
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Expert commentary on why this trial matters and what to watch for.
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