Description:
The purpose of this study is to evaluate the safety and tolerability of parsaclisib when
combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with
relapsed or refractory B-cell lymphoma.
Title
- Brief Title: INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
- Official Title: A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
Clinical Trial IDs
- ORG STUDY ID:
INCB 50465-112 (CITADEL-112)
- SECONDARY ID:
Parsaclisib
- NCT ID:
NCT03424122
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Parsaclisib | INCB050465 | Treatment A |
Rituximab | Rituxan | Treatment A |
Bendamustine | Treanda, Bendeka | Treatment B |
Ibrutinib | Imbruvica | Treatment C |
Purpose
The purpose of this study is to evaluate the safety and tolerability of parsaclisib when
combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with
relapsed or refractory B-cell lymphoma.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment A | Experimental | Parsaclisib + Rituximab | |
Treatment B | Experimental | Parsaclisib + Bendamustine + Rituximab | - Parsaclisib
- Rituximab
- Bendamustine
|
Treatment C | Experimental | Parsaclisib + Ibrutinib | |
Eligibility Criteria
Inclusion Criteria:
- Men and women, aged 18 years or older on the day of signing the Informed Consent Form
(ICF).
- Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.
- Participants with DLBCL, MZL or MCL must have received at least 1 prior line of
systemic therapy with documented progression or documented failure to achieve CR or PR
after the most recent systemic treatment regimen.
- Participants with FL must have received at least 2 prior lines of systemic therapy
with documented progression or documented failure to achieve CR or PR after the most
recent systemic treatment regimen.
- Ineligible for stem cell transplant.
- Participants with DLBCL must have failed or refused stem cell transplantation or
failed first-line salvage therapy if ineligible for transplantation.
- Must be willing to undergo an incisional or excisional lymph node or tissue biopsy or
to provide a lymph node or tissue biopsy from the most recent available archival
tissue.
- Life expectancy of > 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 (see
Appendix D).
- Willingness to avoid pregnancy or fathering a child.
- Ability to comprehend and willingness to sign an ICF
Exclusion Criteria:
- Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
- Histologically confirmed rare non-Hodgkin B-cell subtypes.
- History of or central nervous system lymphoma (either primary or metastatic) or
leptomeningeal disease.
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K
inhibitor.
- For participants to be treated with bendamustine (Treatment B), prior treatment with
bendamustine (within 12 months of the start of study treatment). Participants with
prior bendamustine treatment (> 12 months before the start of study treatment) are
eligible if they meet the following criteria:
- Did not discontinue because of tolerability concerns.
- Achieved either partial response (PR) or complete response (CR) to the
bendamustine regimen of at least 12 months in duration before
relapse/progression.
- Experienced progression following a regimen containing an alkylating agent.
- For participants to be treated with ibrutinib (Treatment C), prior treatment with a
Bruton's tyrosine kinase (BTK) inhibitor.
- Allogeneic stem cell transplant within the last 6 months or autologous stem cell
transplant within the last 3 months before the date of the first dose of study
treatment.
- Active graft-versus-host disease following allogeneic transplant.
- Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of treatment-emergent adverse events (TEAEs) |
Time Frame: | Up to approximately 12 months. |
Safety Issue: | |
Description: | A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment. |
Secondary Outcome Measures
Measure: | Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib |
Time Frame: | Up to approximately 1 month. |
Safety Issue: | |
Description: | Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib. |
Measure: | Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib |
Time Frame: | Up to approximately 1 month. |
Safety Issue: | |
Description: | Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Diffuse large B-cell lymphoma (DLBCL)
- follicular lymphoma (FL)
- marginal zone lymphoma (MZL)
- mantle cell lymphoma (MCL)
- phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor
Last Updated
July 19, 2021