CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Ibrutinib +1 moredrug
Likely dose
Ibrutinib 420 mg orally daily; Venetoclax orally daily escalating from 20 mg to 400 mg (5-dose escalation, one level increase every 7 days)AI-extracted
Key inclusion· 8
  • ✓Confirmed diagnosis of CLL meeting IWCLL/NCI-WG criteria
  • ✓Relapsed or refractory disease with indication for treatment per 2008 IWCLL/NCI-WG criteria
  • ✓Measurable nodal disease on CT scan
  • ✓ECOG performance status 0, 1, or 2
Key exclusion· 12
  • ✕Prior receipt of venetoclax or ibrutinib
  • ✕Richter transformation confirmed by biopsy
  • ✕Recent chemotherapy (≤21 days) or monoclonal antibody therapy (≤6 weeks)
  • ✕Allogeneic stem cell transplant within past 1 year or active chronic GVHD

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03045328
NCT03045328Phase 2Completed
CompareCT.gov

An Open Label Phase 2 Trial of Venetoclax With Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Steven E. Coutre·interventional·Posted Feb 7, 2017·Updated Sep 29, 2021

In Brief

A Phase 2 clinical trial evaluating Ibrutinib and Venetoclax for Recurrent Chronic Lymphocytic Leukemia and 3 related conditions. Completed, enrolled 22 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 7, 2017
Enrollment StartSep 26, 2017
Primary CompletionMay 19, 2020
Study CompletionAug 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.4 years ago

Interventions

Ibrutinibdrug

Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.

Venetoclaxdrug

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).