INCB040093 + Itacitinib for B-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have received ≥ 1 prior treatment regimen.

The subject must not be a candidate for potentially curative therapy, including stem cell transplant.

Must not have

Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.

Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug combination to find the best dose for people with relapsed or refractory B-cell malignancies.

Who is the study for?

Adults with B-cell lymphoma or other B-cell malignancies who have tried at least one treatment and aren't eligible for curative therapies like stem cell transplants. They should be in a condition to live at least 12 more weeks, not have brain involvement by cancer, and can't be recovering from recent cancer treatments or active infections.

What is being tested?

The trial is testing INCB040093 alone and combined with itacitinib on people with B-cell cancers. It has three parts: finding the safest dose of INCB040093, then its combination with itacitinib, and finally evaluating these doses in patients whose disease returned after treatment.

What are the potential side effects?

Potential side effects are not specified but may include typical reactions to cancer drugs such as fatigue, nausea, liver issues, blood count changes, risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured for each patient at cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15 for reporting.