TerminatedPhase 2

Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia

Stopped: Low accrual

United States1 participantsStarted 2020-07-30

Plain-language summary

This study evaluates the safety and efficacy of daratumumab in combination with ibrutinib in patients with Waldenstrӧm's macroglobulinemia (WM). The study will evaluate this combination in two cohorts. Cohort A will comprise of ibrutinib naïve WM patients. Patients in this cohort may be treatment naïve or relapsed but who remain ibrutinib naïve. Cohort B will comprise of patients who are currently receiving ibrutinib but whose response to treatment has plateaued. In this cohort, daratumumab will be added on to ibrutinib in an attempt to deepen response.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Ibrutinib naïve subjects may be either treatment naïve or previously treated but ibrutinib naïve to enter cohort A.
✓. Subjects entering cohort B must have a plateau response on ibrutinib defined as ≥ 6 months of ibrutinib treatment with 2 IgM measurements at least 2 months apart with ≤ 15% change from the previous measurement. Subjects with IgM level \< 0.7 g/dL will be eligible if their IgM level increases \< 0.15 g/dL over two subsequent IgM measurements as defined above.
✓. Absolute neutrophil count (ANC) ≥ 1000/mm3 independent of growth factor support for 7 days of study entry if cytopenias are due to marrow involvement.
✓. Platelets ≥ 50,000/mm3 independent of transfusion support within 7 days of study entry. TPO mimetics are not allowed to meet eligibility criteria.
✓. Hemoglobin ≥ 8g/dL, independent of transfusion support within 7 days of study entry

What they're measuring

Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event

Timeframe: 3 months

Trial details

NCT IDNCT03679624

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-15

Results submitted2023-08-01

View on ClinicalTrials.gov More Waldenstrom Macroglobulinemia trials