Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ann Arbor Stage II Follicular Lymphoma
- Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage II Marginal Zone Lymphoma
- Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Indolent Non Hodgkin Lymphoma
- Ann Arbor Stage III Follicular Lymphoma
- Ann Arbor Stage III Marginal Zone Lymphoma
- Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage IV Follicular Lymphoma
- Ann Arbor Stage IV Marginal Zone Lymphoma
- High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- Diffuse Large B Cell Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma (DLBCL). (Phase I) II. To assess the complete metabolic response rate by positron emission tomography (PET) (PET complete response [CR]) of ...
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma (DLBCL). (Phase I) II. To assess the complete metabolic response rate by positron emission tomography (PET) (PET complete response [CR]) of combining parsaclisib and R-CHOP in patients with newly diagnosed DLBCL. (Dose Expansion) SECONDARY OBJECTIVES: I. To describe the toxicities associated with parsaclisib in combination with R-CHOP. (Phase I) II. To assess the objective response rate (ORR) of parsaclisib in combination with R-CHOP. (Dose Expansion) III. To assess the duration of response (DOR), event-free survival (EFS), progression-free survival (PFS), and overall survival (OS). (Dose Expansion) IV. To further describe the toxicities associated with parsaclisib in combination with R-CHOP. (Dose Expansion) OUTLINE: This is a dose-escalation study of parsaclisib. Patients receive parsaclisib orally (PO) once daily (QD) on days 1-10 or 1-14, rituximab intravenously (IV) or biosimilar substitute, cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV over 15 minutes on day 1. Patients also receive prednisone PO on days 1-5 and pegfilgrastim subcutaneously (SC) or biosimilar substitute on day 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months during year 1 and every 4 months during year 2. Patients who experience disease progression before the end of year 2 are followed up every 6 months until 5 years after registration.
Tracking Information
- NCT #
- NCT04323956
- Collaborators
- National Cancer Institute (NCI)
- Mayo Clinic in Rochester
- Investigators
- Principal Investigator: Yucai Wang Mayo Clinic in Rochester