Active — Not RecruitingPhase 1/2

Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS

United States55 participantsStarted 2018-07-12

Plain-language summary

This research study is assessing a new drug, duvelisib, in combination with a drug that is already FDA approved, venetoclax, as a possible treatment for participants with CLL or those with Richter's Syndrome

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓-Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
✓-Serum creatinine ≤1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL/min using a 24-hour urine collection

What they're measuring

Complete Response Rate (CRR)

Timeframe: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.

Overall Response Rate (ORR)

Timeframe: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.

Trial details

NCT IDNCT03534323

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

Results submitted2025-11-24

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