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A Phase II Study of Daratumumab Plus Ibrutinib in Patients with Waldenstrom's Macroglobulinemia

Clinical Trial Details

While many treatment options are available, Ibrutinib remains the only approved therapy for patients diagnosed with both previously untreated and previously treated Waldenstrom’s macroglobulinemia (WM). However, despite the impressive response rates of single agent Ibrutinib, the majority of patients receiving this regimen only achieve partial responses due to various factors such as mutations in critical genes. The addition of a novel targeted approach in combination with Ibrutinib may further deepen response rates and improve patients’ overall outcome. 
    
Daratumumab is a monoclonal antibody targeting CD38, a gene which increased evidence suggests is linked to the cell origin for Waldenstrom’s macroglobulinemia. Using Daratumumab in combination with Ibrutinib, this study seeks to target CD38 expression in WM patients both in combination as upfront therapy and as an additive therapy for patients currently on Ibrutinib whose responses have reached a plateau. 
    
Subjects will receive daily, continuous Ibrutinib in addition to Daratumumab weekly for 8 weeks, followed by every other week until 6 months and then monthly until month 26. Subjects will continue to receive Ibrutinib daily after the completion of the Daratumumab study treatment as long as they are responding to therapy and are not experiencing unacceptable side effects. After a total of 4 years of study treatment, subjects will continue to be followed on study for 1 year after completion of treatment or for 28 days after removal from the study. 

Key Eligibility: 

- Men and women age 18 and over 
- Subjects with WM who have not received Ibrutinib previously or previously treated subjects currently on Ibrutinib with a plateau in disease response 
- Detailed eligibility reviewed when you contact the study team 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1708018494

Status

Open to Enrollment

Age Group

Adult

Sponsor