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

Part of paid clinical trials in Miami, Florida.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03534323
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Duvelisib — DRUG
    This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
  • Venetoclax — DRUG
    Venetoclax targets a protein called BCL-2, which helps cancer cells survive.

Study Details

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

Key Dates

Start date
Jul 12, 2018
Status verified
Mar 2026
Primary completion
Dec 1, 2024
Completion
Jul 1, 2026

Study Design

Enrollment
55 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Level 1: 100 mg Venetoclax (daily) + 25 mg Duvelisib (BID)
    Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added. * Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 100mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
  • Experimental: Phase 1 Level 2: 200 mg Venetoclax (daily) + 25 mg Duvelisib (BID)
    * Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 200mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
  • Experimental: Phase 1 Level 3: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID)
    * Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 400mg * All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
  • Experimental: Phase 2: 400 mg Venetoclax (daily) + 25 mg Duvelisib (BID)
    * Duvelisib will be administered orally twice daily of 25mg * Venetoclax will be administered orally daily of 400mg

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle. ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Miami- Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Northern Light Eastern Maine Medical CenterBrewerMaine04412-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Boston Medical CenterBostonMassachusetts02118-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Berkshire Medical CenterPittsfieldMassachusetts01201-

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