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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
There must be a clear way to indicate that you need treatment, either by meeting one or more of the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for treatment (Brice et al. 1997), the existence of cancer-related pain or other uncontrollable symptoms. Study participant whose need for treatment can be supported by the judgment of a primary oncologist based on the pace of their disease progression/other clinical criteria are also eligible for the study. Study participants must have documented progression of disease.
Not be a candidate for standard-of-care chemoimmunotherapy in the judgment of the primary oncologist OR standard chemoimmunotherapy was discussed with the primary oncologist and declined by the participant.
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must have clear signs that you need treatment such as cancer-related pain or uncontrollable symptoms. Alternatively, you meet specific criteria for treatment based on the pace of your disease progression as determined by your primary oncologist. You must also have documented progression of the disease.
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Your primary oncologist has determined that you cannot receive the standard chemotherapy treatment or you have discussed the treatment with your oncologist and decided not to receive it.

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
~1990
CC-486
2015
Completed Phase 2
~580
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
995 Previous Clinical Trials
816,666 Total Patients Enrolled
Sonali Smith, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
136 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please enumerate the experiments involving CC-486 that have already taken place?

"Currently, there are 400 studies involving CC-486 with 61 of them in the advanced testing phase. Most of these trials originate out of Edmonton, Alberta; however 12605 other sites across the world are also participating in clinical research surrounding this drug."

Answered by AI

What is the ceiling for participants in this clinical research?

"Indeed, clinicaltrials.gov reveals that the study is actively recruiting participants - having been posted on September 1st 2021 and recently updated on November 12th 2021. The trial requires 50 patients from a single medical centre to be enrolled."

Answered by AI

Are there vacancies in this experiment open to participants?

"Affirmative. Clinicaltrials.gov reveals that this research endeavor, which was released on September 1st 2021, is actively recruiting participants. Fifty volunteers must be recruited from a single medical centre."

Answered by AI

What outcomes is this clinical trial attempting to accomplish?

"This trial, which is planned to run for 336 days in total, seeks to identify the Maximum Tolerable Dose of Venetoclax and CC-486 via observation of associated Side Effects according to CTCAE Criteria Version 5. Additionally, Secondary aims include determining how many participants no longer exhibit signs of Follicular lymphoma after receiving three cycles of combined oral therapy (as identified by PET Scan per Lugano Criteria), measuring average time spent living with Follicular Lymphoma without worsening symptoms at study end and five years later, as well as calculating when half the Expansion Group are still alive post treatment using Median"

Answered by AI

In what contexts is CC-486 typically administered?

"Induction chemotherapy is commonly managed with CC-486, and this medication may also be beneficial for managing refractory anemias, leukemia, myelocytic disorders, acute cases of multilineage dysplasia."

Answered by AI
~1 spots leftby Mar 2025