ideasIdea

MRD-guided treatment duration in CLL

Instead of a fixed 12 or 15 months, stop each patient's therapy when their blood shows no detectable leukaemia, and restart if it returns.

CAPTIVATE's MRD-guided cohort and FLAIR's MRD-directed ibrutinib-venetoclax arm suggest individualised duration is feasible; SPRUCE-TN (sonrotoclax + zanubrutinib) formalises it. Retreatment at relapse works in most.

Hypothesis

MRD-guided duration (stop at confirmed uMRD ≤10^-4, or continue to a maximum) yields PFS non-inferior to fixed 12-15 months while reducing drug exposure by a third.

Rationale

uMRD at end of treatment is the strongest predictor of PFS; IGHV-mutated patients reach uMRD earlier and stay in remission longer.

What would test it

Randomised MRD-guided vs fixed duration with clonoSEQ monitoring every 3 months; primary endpoint PFS, secondary exposure and cost.

Maturity

being tested at scale

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Pairing
BTK inhibitor + venetoclax, fixed duration
Shares CAPTIVATE, CELESTIAL-TNCLL, Sonrotoclax, Zanubrutinib.
Trial
CLL13 / GAIA
Shares IGHV mutational status, MRD-negative complete remission, Venetoclax, Chronic lymphocytic leukaemia.
Pairing
Caution: chemoimmunotherapy in del(17p)/TP53 CLL
Shares Zanubrutinib, Venetoclax, Chronic lymphocytic leukaemia.
Term
Tumour lysis syndrome (TLS)
Shares Sonrotoclax, Venetoclax, Chronic lymphocytic leukaemia.
Trial
AMPLIFY
Shares IGHV mutational status, Venetoclax, Chronic lymphocytic leukaemia.
Trial
myeloMATCH
Shares NGS-based MRD (clonoSEQ and molecular MRD), MRD-negative complete remission, Venetoclax.
Institution
Northwell Health Cancer Institute
Shares IGHV mutational status, Chronic lymphocytic leukaemia.
Idea
BTK degraders to pre-empt resistance in frontline CLL
Shares Sonrotoclax, Venetoclax, Chronic lymphocytic leukaemia.

MRD-guided treatment duration in CLL

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