Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT04323956
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
  • Ann Arbor Stage II Follicular Lymphoma
  • Ann Arbor Stage II Marginal Zone Lymphoma
  • Ann Arbor Stage III Diffuse Large B-Cell 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
  • Diffuse Large B-Cell Lymphoma
  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Indolent Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Parsaclisib — DRUG
    Given PO
  • Pegfilgrastim — BIOLOGICAL
    Given SC
  • Polatuzumab Vedotin — DRUG
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

This phase I/Ib trial studies the side effects and best dose of parsaclisib with or without polatuzumab-vedotin (Pola) plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone \[PaR-CHOP\]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab-vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as anti-CD79b receptors, and delivers vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.

Key Dates

Start date
Jun 15, 2020
Status verified
Jan 2026
Primary completion
Oct 4, 2023
Completion
May 16, 2028

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (parsaclisib, R-CHOP)
    Patients receive parsaclisib PO QD on days 1-10 or 1-14, rituximab 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 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.
  • Active Comparator: Arm II (parsaclisib, R-CHOP, polatuzumab vedotin)
    Patients receive parsaclisib PO once daily QD on days 1-10 or 1-14, polatuzumab vedotin IV over 90 minutes, rituximab 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 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.

Primary Outcome Measure

Maximum tolerated dose (MTD) of parsaclisib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (Phase I) [ Time Frame: Up to 21 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMayo Clinic in Rochester· Rochester, MN

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