ABBV-383 for Waldenstrom's Macroglobulinemia

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Must be taking: BTK inhibitors

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Pregnancy, HIV, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 12 cycles (28 days each)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of ABBV-383 and to see how well it works in treating patients with Waldenström macroglobulinemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). ABBV-383 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).

Who Is on the Research Team?

Prashant Kapoor, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

Absolute neutrophil count (ANC) ≥ 1000/mm^3 (obtained ≤ 14 days prior to pre-registration)

Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 14 days prior to pre-registration)

Willingness to provide mandatory blood and bone marrow samples specimens for correlative research

Exclusion Criteria

I have had a lymphoproliferative disorder in the past.

I have had another active cancer in the past.

I have had an organ transplant and still need to take immunosuppressant drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Patients receive ABBV-383 IV on days 1 and 4 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 12 cycles.

Up to 12 cycles (28 days each)

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT or PET/CT scans and blood and urine sample collection.

Up to 90 days from last dose

Regular monitoring visits

Long-term follow-up

Participants are monitored for progression-free survival and overall survival.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-383

How Is the Trial Designed?

Group I: Treatment (ABBV-383) Experimental Treatment 7 Interventions

Patients receive ABBV-383 IV as a single push or over 30 minutes to 4 hours on days 1 and 4 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT during screening and blood and urine sample collection and bone marrow aspiration and biopsy throughout the trial. Additionally, patients with extramedullary disease undergo CT or PET/CT throughout the trial.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+