A Study of INCB039110 in Combination With Ibrutinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 25 March 2021

Summary

A Study of INCB039110 in Combination With Ibrutinib in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Description

The purpose of this study is to evaluate the safety/tolerability and efficacy of INCB039110 in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

For more information, please contact Incyte Corporation at 1.855.463.3463.

Details
Clinical Study IdentifierTX147673
SponsorIncyte Corporation
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Histologically documented diagnosis of DLBCL. (Phase 1: any DLBCL subtype. Phase 2: activated B-cell or unclassifiable subtypes confirmed by immunohistochemistry using the Hans algorithm)
Relapsed or refractory DLBCL, defined as having received at least 1 but no more than 3 prior treatment regimens and ineligible for high-dose chemotherapy/autologous stem cell transplant
At least 1 measurable (= 2 cm in longest dimension) lesion on CT scan or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria

Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or mucosa-associated lymphoid tissue lymphoma)
Primary mediastinal (thymic) large B-cell lymphoma
Known central nervous system lymphoma (either primary or metastatic)
Allogeneic stem cell transplant within the previous 6 months, or active graft versus host disease following allogeneic transplant
Use of immunosuppressive therapy within 28 days of starting study treatment. Immunosuppressive therapy includes but is not limited to cyclosporine A, tacrolimus, or high-dose corticosteroids. Subjects receiving corticosteroids must be at a dose level = 20 mg/day within 7 days of initiating study treatment
Prior or concurrent therapy with a Janus kinase inhibitor, Bruton's tyrosine kinase inhibitor, or lenalidomide (Phase 2 only)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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