Chemotherapy plus Ofatumumab at Standard or Mega dose in relapsed CLL (COSMIC) trial: study protocol for a phase II randomised controlled trial

Table 1 Schedule of enrolment, interventions and assessments

	Eligibility screening	Randomisation	Baseline	After 3 cycles of therapy	At end of therapy	3 months post therapy	12, 18 and 24 months post randomisation	After 24 months post randomisation	Annual follow-up
Enrolment
Eligibility screening	X
Informed consent	X
Medical history	X
Local chemotherapy decision (FC or B)	X
Randomisation		X
Intervention
Standard Of-FC/B
Mega Of-FC/B
Assessments
CT scan	X					X	X^a
Assessment of disease			X	X		X	X
Peripheral blood for MRD^b	X			X		X^c	X^c	X^c
Bone marrow aspirate for MRD^b	X					X
Performance status	X		X	X	X	X	X
Laboratory tests (haematology)	X		X	X	X	X	X
Laboratory tests (biochemistry)	X		X	X	X
Body surface area^d			X	X
ARs and SAEs		From randomisation until 30 days after the last dose of treatment
SARs and SUSARs		From randomisation until the end of the trial
Survival status									X

Standard Of-FC/B standard dose ofatumumab + fludarabine and cyclophosphamide/bendamustine, Mega Of-FC/B mega dose ofatumumab + fludarabine and cyclophosphamide/bendamustine, MRD minimal residual disease, AR adverse event, SAE serious adverse event, SAR serious adverse reaction, SUSAR suspected unexpected serious adverse reaction
^aIf appropriate clinically
^bTested centrally
^cTaken on a 3-monthly basis until five consecutive MRD positive results
^dBefore each cycle of therapy and dose changed if greater than 10 % change from baseline

ISSN: 1745-6215