A study evaluating the impact of Itacitinib when added to Ibrutinib for the treatment of relapsed or refractory diffuse large B-Cell lymphoma

Phase 1

• Conditions: Relapsed or refractory diffuse large B-cell lymphoma; MedDRA version: 20.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10012821 Term: Diffuse large B-cell lymphoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-002773-19-GB
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 78

Inclusion Criteria

• Male or female, 18 years or older.
• Histologically documented diagnosis of DLBCL.
- For Phase 1, subjects may have any DLBCL subtype.
- For Phase 2, subjects must have ABC or unclassifiable subtypes of DLBCL 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.
• Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano Classification. Fluorodeoxyglucose-avid disease is defined as disease with a 5-point scale score of 4 or 5.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

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).
• Autologous stem cell transplant within the previous 3 months, allogeneic stem cell transplant within the previous 6 months, or active graft versus host disease following allogeneic transplant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified