A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor

Withdrawn before enrolling · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Non-Hodgkin Lymphoma

In brief

This study is designed to assess the safety, pharmacokinetics, drug-drug interactions, and determine the recommended Phase 2 doses of co administered Duvelisib and Venetoclax in participants with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, or indolent or aggressive non-Hodgkin lymphoma, who have not previously received a Bcl-2 or Phosphoinositide 3-kinase (PI3K) inhibitor. The Phase 2 portion of the study will preliminarily evaluate efficacy, and expand the toxicity evaluation.

Key facts

Study ID

NCT02640833

Run by

AbbVie

People needed

0

Starts

2016-07-01

Expected to finish

2021-02-01

Last updated by the study team

2016-07-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subject has been previously treated with a Bcl-2 or PI3K inhibitor.
• Subject is a candidate to receive another second-line therapy approved for usage by the local Health Authority.
• Subject is appropriate for a stem cell transplant or has undergone an allogeneic stem cell transplant.
• Subject has received any of the following within 14 days or 5 drug half-lives (whichever is shortest) prior to the first dose of duvelisib or venetoclax, or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
• Any anti-cancer therapy including chemotherapy or radiotherapy;
• Investigational therapy, including targeted small molecule agents.
• Subject has received biologic agents (e.g., monoclonal antibodies) for anti-neoplastic treatment within 30 days prior to first dose of duvelisib or venetoclax.
• Subject has received live or live attenuated vaccines within 6 weeks prior to first dose of duvelisib or venetoclax.
• Subject has received the following within 7 days prior to the first dose of duvelisib or venetoclax:
• Steroid therapy for anti-neoplastic treatment;
• Strong and Moderate CYP3A inhibitors;
• Strong and Moderate CYP3A inducers;
• Chronic immunosuppressants, other than corticosteroids given at daily dose < 20 mg prednisone equivalent for ITP or AIHA.

Where it is running

• Site Reference ID/Investigator# 145677 — Tucson, Arizona, United States
• Site Reference ID/Investigator# 147922 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 148562 — Harvey, Illinois, United States
• Site Reference ID/Investigator# 148561 — Goshen, Indiana, United States
• Site Reference ID/Investigator# 145674 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 145145 — Boston, Massachusetts, United States
• Site Reference ID/Investigator# 148010 — Detroit, Michigan, United States
• Site Reference ID/Investigator# 147747 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 145146 — Lebanon, New Hampshire, United States
• Site Reference ID/Investigator# 148559 — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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