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

An Open-Label Phase 1/2 Study of INCB039110 in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002773-19-GB

Enrollment

Registered

2018-07-03

Start date

2018-06-14

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 lymphom

Interventions

Product Name: Itacitinib Product Code: INCB039110 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: ITACITINIB ADIPATE C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of Phase 1 is to evaluate the safety and tolerability of INCB039110 in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The primary objective of Phase 2 is to evaluate the efficacy of INCB039110 in combination with ibrutinib in subjects with relapsed or refractory non-GCB DLBCL as demonstrated by ORR. ; Secondary Objective: The secondary objective of Phase 1 is to evaluate the efficacy of INCB039110 in combination with ibrutinib in terms of objective response rate (ORR). The secondary objectives of Phase 2 are as follows: • To evaluate efficacy in terms of duration of response (DOR), durable response rate, progression-free survival (PFS), and overall survival (OS). • To evaluate the safety and tolerability of the treatment combination. ; Primary end point(s): Phase 1 : Safety and tolerability will be assessed by evaluating the frequency, duration, and severity of AEs (including serious adverse events [SAEs] and dose-limiting toxicities [DLTs]), and changes in clinical and laboratory assessments. Phase 2 : Efficacy will be assessed by ORR, defined as the percentage of subjects achieving either a CR or PR. ; Timepoint(s) of evaluation of this end point: Phase 1: Adverse events will be monitored from the time the subject signs the ICF through the safety follow-up. A DLT will be defined as the occurrence of any toxicities occurring up to and including Day 28. Phase 2 : Week 8, Week 16, and every 16 weeks thereafter until disease progression.	—

Measure

Time frame

Main Objective: The primary objective of Phase 1 is to evaluate the safety and tolerability of INCB039110 in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The primary objective of Phase 2 is to evaluate the efficacy of INCB039110 in combination with ibrutinib in subjects with relapsed or refractory non-GCB DLBCL as demonstrated by ORR. ; Secondary Objective: The secondary objective of Phase 1 is to evaluate the efficacy of INCB039110 in combination with ibrutinib in terms of objective response rate (ORR). The secondary objectives of Phase 2 are as follows: • To evaluate efficacy in terms of duration of response (DOR), durable response rate, progression-free survival (PFS), and overall survival (OS). • To evaluate the safety and tolerability of the treatment combination. ; Primary end point(s): Phase 1 : Safety and tolerability will be assessed by evaluating the frequency, duration, and severity of AEs (including serious adverse events [SAEs] and dose-limiting toxicities [DLTs]), and changes in clinical and laboratory assessments. Phase 2 : Efficacy will be assessed by ORR, defined as the percentage of subjects achieving either a CR or PR. ; Timepoint(s) of evaluation of this end point: Phase 1: Adverse events will be monitored from the time the subject signs the ICF through the safety follow-up. A DLT will be defined as the occurrence of any toxicities occurring up to and including Day 28. Phase 2 : Week 8, Week 16, and every 16 weeks thereafter until disease progression.

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Secondary

Measure	Time frame
Secondary end point(s): Phase 1 : Efficacy will be assessed by ORR, defined as the percentage of subjects achieving either a complete response (CR) or partial response (PR). Phase 2 : • DOR, defined as the time from earliest date of disease response until earliest date of disease progression. • Durable response rate, defined as the percentage of subjects achieving a CR or PR for > 16 weeks. • PFS, defined as the time from enrollment until the earliest date of disease progression determined by objective radiographic disease assessments, or death due to any cause. • OS, defined as the date of enrollment until death due to any cause. • Safety and tolerability via assessment of the frequency, duration, and severity of AEs and SAEs, and changes in clinical and laboratory assessments. ; Timepoint(s) of evaluation of this end point: Adverse events will be monitored from the time the subject signs the ICF through the safety follow-up. Efficacy endpoints: Week 8, Week 16, and every 16 weeks thereafter until disease progression.	—

Measure

Time frame

Secondary end point(s): Phase 1 : Efficacy will be assessed by ORR, defined as the percentage of subjects achieving either a complete response (CR) or partial response (PR). Phase 2 : • DOR, defined as the time from earliest date of disease response until earliest date of disease progression. • Durable response rate, defined as the percentage of subjects achieving a CR or PR for > 16 weeks. • PFS, defined as the time from enrollment until the earliest date of disease progression determined by objective radiographic disease assessments, or death due to any cause. • OS, defined as the date of enrollment until death due to any cause. • Safety and tolerability via assessment of the frequency, duration, and severity of AEs and SAEs, and changes in clinical and laboratory assessments. ; Timepoint(s) of evaluation of this end point: Adverse events will be monitored from the time the subject signs the ICF through the safety follow-up. Efficacy endpoints: Week 8, Week 16, and every 16 weeks thereafter until disease progression.

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Countries

Belgium, France, Italy, Netherlands, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Incyte Corporation

RA@incyte.com13024252734

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026