INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

Incyte

Status and phase: Completed; Phase 1

Conditions: B-cell Lymphoma

Treatments: Drug: Bendamustine; Drug: Rituximab; Drug: Parsaclisib; Drug: Ibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03424122

2017-004088-11 (EudraCT Number)

Parsaclisib (Other Identifier)

INCB 50465-112 (CITADEL-112)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Treatment A

Experimental group

Description:

Parsaclisib + Rituximab

Treatment:

Drug: Parsaclisib

Drug: Rituximab

Treatment B

Experimental group

Description:

Parsaclisib + Bendamustine + Rituximab

Treatment:

Drug: Parsaclisib

Drug: Rituximab

Drug: Bendamustine

Treatment C

Experimental group

Description:

Parsaclisib + Ibrutinib

Treatment:

Drug: Ibrutinib

Drug: Parsaclisib