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ABBV-453 + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 1

Recruiting

Research Sponsored by AbbVie

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new drug, ABBV-453, for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in adults

Who is the study for?

This trial is for adults with CLL/SLL who have tried at least two cancer treatments and don't have better treatment options. They must meet certain lab value criteria to participate.

What is being tested?

The study tests ABBV-453, a new drug for CLL/SLL. Participants will receive varying doses after an initial obinutuzumab period, aiming to find the right dose. The study has two parts and involves regular hospital visits over five years.

What are the potential side effects?

Specific side effects aren't listed, but participants may experience a higher treatment burden compared to standard care. Side effects will be monitored through medical assessments and blood tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A and B: Percentage of Participants With Adverse Events (AEs)

Part A: Maximum Administered Dose (MAD) of ABBV-453

Part A: Maximum Tolerated Dose (MTD) of ABBV-453

Secondary study objectives

Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453

Part A and B: Complete response rate (CRR)

Part A and B: Duration of Complete Response (DOCR)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part B: Cohort 2.2 ABBV-453 Dose EExperimental Treatment1 Intervention

Participants will no participate in the debulking period and receive escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.

Group II: Part B: Cohort 2.1 ABBV-453 Dose EExperimental Treatment2 Interventions

Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.

Group III: Part A: Cohort 1.5 ABBV-453 Dose EExperimental Treatment2 Interventions

Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.

Group IV: Part A: Cohort 1.4 ABBV-453 Dose DExperimental Treatment2 Interventions

Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose D is achieved, during the 5 year study duration.

Group V: Part A: Cohort 1.3 ABBV-453 Dose CExperimental Treatment2 Interventions

Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose C is achieved, during the 5 year study duration.

Group VI: Part A: Cohort 1.2 ABBV-453 Dose BExperimental Treatment2 Interventions

Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose B is achieved, during the 5 year study duration.

Group VII: Part A: Cohort 1.1 ABBV-453 Dose AExperimental Treatment2 Interventions

Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose A is achieved, during the 5 year study duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obinutuzumab

2014

Completed Phase 3

~3470

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