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
Treatment Effectiveness
Study Objectives
4 Primary · 4 Secondary · Reporting Duration: 55 months (at study conclusion) and 5 years after end of study
Year 4
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
Day 336
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: Number of Participants Who Discontinue Venetoclax, CC-486 and Obinutuzumab Regimen Due to Reported Side Effects as Assessed by CTCAE Criteria Version 5
Day 336
Phase I Objective: Number of Participants Taking Venetoclax, CC-486 and obinutuzumab Who Report Serious Side Effects As Assessed by CTCAE Version 5
Day 336
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
Year 5
Malignant Neoplasms
Phase II Objective: The Length of Time That Half of Participants in the Expansion Group Are Alive After Receiving Phase 1 Dose of Treatment As Assessed at End of Study and 5 Years After Study is Complete
Day 84
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)
Trial Safety
Trial Design
6 Treatment Groups
Phase 1 (Dose-Finding Arm) - Group 4 - Lower Dose Level 1
1 of 6
Phase 1 (Dose-Finding Arm) - Group 3 - Dose Level 3/ Highest Dose
1 of 6
Phase 1(Dose-Finding Arm): Group 2 - Dose Level 2 /Second Dose
1 of 6
Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 / Starting Dose
1 of 6
Phase 2 (Efficacy Arm/ Expansion Cohort)
1 of 6
Phase 1 (Dose-Finding Arm) - Group 5 - Lower Dose Level 2
1 of 6
Experimental Treatment
50 Total Participants · 6 Treatment Groups
Primary Treatment: CC-486 · No Placebo Group · Phase 1 & 2
Phase 1 (Dose-Finding Arm) - Group 4 - Lower Dose Level 1Experimental Group · 3 Interventions: CC-486, Venetoclax, Obinutuzumab · Intervention Types: Drug, Drug, Drug
Phase 1 (Dose-Finding Arm) - Group 3 - Dose Level 3/ Highest DoseExperimental Group · 3 Interventions: CC-486, Venetoclax, Obinutuzumab · Intervention Types: Drug, Drug, Drug
Phase 1(Dose-Finding Arm): Group 2 - Dose Level 2 /Second DoseExperimental Group · 3 Interventions: CC-486, Venetoclax, Obinutuzumab · Intervention Types: Drug, Drug, Drug
Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 / Starting DoseExperimental Group · 3 Interventions: CC-486, Venetoclax, Obinutuzumab · Intervention Types: Drug, Drug, Drug
Phase 2 (Efficacy Arm/ Expansion Cohort)Experimental Group · 3 Interventions: CC-486, Venetoclax, Obinutuzumab · Intervention Types: Drug, Drug, Drug
Phase 1 (Dose-Finding Arm) - Group 5 - Lower Dose Level 2Experimental Group · 3 Interventions: CC-486, Venetoclax, Obinutuzumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Venetoclax
FDA approved
Obinutuzumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 55 months (at study conclusion) and 5 years after end of study
Who is running the clinical trial?
University of ChicagoLead Sponsor
925 Previous Clinical Trials
753,282 Total Patients Enrolled
Sonali Smith, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
136 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a diagnosis of Stage II-IV disease on screening PET imaging with measurable disease, according to the Lugano Classification
You are not a candidate for standard-of-care chemoimmunotherapy in the judgment of the primary oncologist.
You are of childbearing potential.
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Conditions
Cancer Related
Treatments