Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL

Part of paid clinical trials in Duarte, California.

Sponsor
Steven E. Coutre
Study ID
NCT03045328
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
  • Venetoclax — DRUG
    Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).

Study Details

This is an open-label non-randomized two-center phase 2 study evaluating the safety and efficacy of concurrent therapy with ibrutinib and venetoclax in subjects with relapsed or refractory CLL/SLL.

Key Dates

Start date
Sep 26, 2017
Status verified
Sep 2021
Primary completion
May 19, 2020
Completion
Aug 5, 2021

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib, venetoclax)
    Patients receive ibrutinib PO QD beginning on week 1 day 1. Treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity. Patients also receive venetoclax PO QD beginning on week 9 day 1. Treatment with venetoclax continues up to week 61 day 7 in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete Response (CR) [ Time Frame: 62 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Stanford University, School of MedicineStanfordCalifornia94305-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAStanford University, School of Medicine· Stanford, CA

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