Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT03679624
Phase
PHASE2
Status
Terminated

Conditions

  • Waldenstrom Macroglobulinemia
  • Waldenstrom's Disease
  • Waldenstrom's Macroglobulinaemia, Without Mention of Remission
  • Waldenstrom's Macroglobulinemia Recurrent
  • Waldenstrom's Macroglobulinemia Refractory
  • Waldenstrom's Macroglobulinemia of Lymph Nodes
  • Waldenström; Hypergammaglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib, 420mg orally, once daily
  • Daratumumab — DRUG
    Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.

Study Details

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.

Key Dates

Start date
Jul 30, 2020
Status verified
Sep 2023
Primary completion
Sep 15, 2020
Completion
Oct 13, 2020

Study Design

Enrollment
1 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - Ibrutinib naive
    Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab
  • Experimental: Cohort B - Ibrutinib response plateau
    Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab

Primary Outcome Measure

Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Weill Cornell Medicine· New York, NY

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