BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnne Louise Tølbøll Sørensen
About this trial
BLOOD-dose is a multicentre, adaptive, randomized, multidomain platform trial designed to optimize treatment dosing strategies in adult patients with haematological diseases.
The BLOOD-dose core protocol outlines the overall clinical trial design that applies to all included interventions, while domain-specific appendices (DSA) detail the unique characteristics of each domain and specify domain-specific interventions.
New domains will be incorporated over time to address distinct dose-optimization research questions across different haematological conditions and interventions.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- teclistamab OR talquetamab OR elranatamab OR linvoseltamab
- BTK inhibitors (ibrutinib and zanubrutinib)
Treatment groups
400 Participants
are divided into 4 treatment groupsSponsors and collaborators
Anne Louise Tølbøll Sørensen
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov