Study Details

Open

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

In this study, we will look at two medicines called venetoclax and obinutuzumab for patients whose chronic lymphocytic leukemia has come back. We will also check if this treatment is safe for them.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study involves questionnaires, physical examination, urine and blood tests, ECG, and pregnancy testing. The study also involves CT or MRI scan, bone marrow aspirate/biopsy, Biomarker research, and study drugs.

Incentives

Study Medication, travel reimbursement

In-person visits:
0-25+ times

Phone or online visits:
0-10 times

Total length of participation:
Cohort 1: 12 months of treatment; Cohort 2: 24 months of treatment; Both Cohorts up to 3 years of follow-up after treatment

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with CLL that requires retreatment
You have previously completed Venetoclax + an anti-CD20 antibody and achieved documented response
It has been 12- 24 months between the last dose of Venetoclax and progression requiring treatment
You have not received an intervening treatment for CLL after completing previous treatment with venetoclax

Not eligible if:

Your CLL has transformed to aggressive NHL (such as Richter's transformation or pro-lymphocytic leukemia)
You have central nervous system involvement of your CLL
You have been diagnosed with HIV, HBV or Hepatitis C
Have an active/uncontrolled infection (bacterial, viral, or fungal) requiring systemic IV treatment within the last 2 weeks prior to enrollment
You have cardiovascular issues

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Comprehensive Cancer Center
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Christopher Jensen
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Blood Conditions
Cancer (Lymphoma)

IRB Number

24-3105

ClinicalTrials.gov

NCT04895436