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Anti-cancer agent

CC-486 for Follicular Lymphoma

Phase 1 & 2
Waitlist Available
Led By Sonali Smith, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 55 months (at study conclusion) and 5 years after end of study
Awards & highlights

Study Summary

This trial is testing a 3-drug combination to treat minimally pretreated follicular lymphoma that has progressed despite other therapies. The goal is to find a safe and tolerable dose, and to compare the effectiveness of this combination to the current standard of care.

Eligible Conditions
  • Follicular Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~55 months (at study conclusion) and 5 years after end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 55 months (at study conclusion) and 5 years after end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
4. Phase II Objective: Number of Participants Who Do Not Show Signs of Cancer After Taking CC-486 and Obinutuzumab (Oral Therapies) As Assessed by PET/CT Whole Body Scan (Based on Lugano Criteria)
Phase I Objective: Maximum Tolerated Dose of Venetoclax and CC-486 As Assessed by Rate of Reported Dose Limiting Toxicities (Side Effects) According to CTCAE Criteria Version 5
Phase I Objective: Number of Participants Taking Venetoclax, CC-486 and Obinutuzumab Who Report Serious Side Effects As Assessed by CTCAE Version 5
+1 more
Secondary outcome measures
Phase II Objective: Number of Participants Who Do Not Show Signs of Follicular Lymphoma 30 Months After Treatment As Assessed by PET Scan (Based on Lugano Criteria
Phase II Objective: Number of Participants Who Do Not Show Signs of Follicular Lymphoma After Venetoclax and CC-486 As Assessed by PET Scan (Based on Lugano Criteria)
Malignant Neoplasms
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 2 (Efficacy Arm/ Expansion Cohort)Experimental Treatment3 Interventions
Participants in this arm will help test the efficacy of the three-drug regimen and dose established in the phase 1 of the study. Participants will take two drugs (venetoclax and CC-48) used in the same three-drug regimen during the first phase of this study. These two drugs will be paired together by themselves and given to participants in the expansion cohort before obinutuzumab (a third drug) is added during cycle 4 of treatment.
Group II: Phase 1(Dose-Finding Arm): Group 2 - Dose Level 2 /Second DoseExperimental Treatment3 Interventions
Participants in group 2 will receive a three-drug regimen of venetoclax, CC-486, and obinutuzumab at the second highest dose (dose level 2) set by doctors leading the study. Participants in this group will receive: Venetoclax: 600 mg on days 1-28 CC-486: 200 mg on days 1-14 Obinutuzumab: 1000 mg on days 1, 8 and 15 of cycle 1, and on day 1 of each following cycle. Treatment using these three study drugs (venetoclax, CC-486, and obinutuzumab) will be given in 12 consecutive cycles that run for 28 days during each cycle (336 days).
Group III: Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 / Starting DoseExperimental Treatment3 Interventions
Phase 1/the dose-finding arm of this study will use three dose levels (a starting dose, second dose and highest dose) of the venetoclax, CC-486 and obinutuzumab regimen. If participants in group 1 don't experience severe negative side effects to the starting dose of the regimen, then more participants will be assigned to groups 2 and 3 to take higher doses until the safest/ most tolerable dose is found. Group 1/ Dose Level 1: Participants in group 1 will receive a three-drug regimen of venetoclax, CC-486, and obinutuzumab at a starting dose used in previous human studies. Participants in this group will receive: Venetoclax: 400 mg on days 1-28 CC-486: 200 mg on days 1-14 Obinutuzumab: 1000 mg on days 1, 8 and 15 of cycle 1, and on day 1 of each following cycle. Treatment using these three study drugs (venetoclax, CC-486, and obinutuzumab) will be given in 12 consecutive cycles that run for 28 days during each cycle (336 days).
Group IV: Phase 1 (Dose-Finding Arm) - Group 5 - Lower Dose Level 2Experimental Treatment3 Interventions
Participants in this group will received the second lowest dose of the three-drug regimen using venetoclax, CC-486 and obinutuzumab set by doctors leading the study. Inclusion in this group is optional and based on whether the participant reports serious adverse events/side effects in response to a higher dose of the regimen. If participants are included in this group, they will receive: Venetoclax: 400 mg on days 1-10 only CC-486: 150 mg on days 1-14 Obinutuzumab: 1000 mg on days 1, 8 and 15 of cycle 1, and on day 1 of each following cycle.
Group V: Phase 1 (Dose-Finding Arm) - Group 4 - Lower Dose Level 1Experimental Treatment3 Interventions
Participants in this group will received a lower dose of the three-drug regimen using venetoclax, CC-486 and obinutuzumab set by doctors leading the study. Inclusion in this group is optional and based on whether the participant reports serious adverse events/side effects in response to a higher dose of the regimen. If participants are included in this group, they will receive: Venetoclax: 400 mg on days 1-28 CC-486: 150 mg on days 1-14 Obinutuzumab: 1000 mg on days 1, 8 and 15 of cycle 1, and on day 1 of each following cycle.
Group VI: Phase 1 (Dose-Finding Arm) - Group 3 - Dose Level 3/ Highest DoseExperimental Treatment3 Interventions
Participants in group 3 will receive a three-drug regimen of venetoclax, CC-486, and obinutuzumab at the highest dose (dose level 3) set by doctors leading the study. Participants in this group will receive: Venetoclax: 800 mg on days 1-28 CC-486: 200 mg on days 1-14 Obinutuzumab: 1000 mg on days 1, 8 and 15 of cycle 1, and on day 1 of each following cycle. Treatment using these three study drugs (venetoclax, CC-486, and obinutuzumab) will be given in 12 consecutive cycles that run for 28 days during each cycle (336 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1950
CC-486
2015
Completed Phase 2
~630
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,012 Previous Clinical Trials
734,068 Total Patients Enrolled
Sonali Smith, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
136 Total Patients Enrolled
~1 spots leftby Jun 2025
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