Active — Not RecruitingPhase 1

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

United States50 participantsStarted 2020-06-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>= 18 years * Newly diagnosed, untreated, histologically confirmed diffuse large B-cell lymphoma expressing the CD20 antigen, with ANY of the following: * Non-germinal center B-cell (GCB) subtype by Hans algorithm * Myc expression \>= 40% by immunohistochemistry (IHC) * Bcl-2 expression \>= 50% by IHC * Myc expression \>= 40% AND Bcl-2 expression \>= 50% by IHC (double expressor) * MYC rearrangement by fluorescence in situ hybridization (FISH) * Or high-grade B-cell lymphoma with MYC rearrangement AND BCL2 and/or BCL6 rearrangement (double-hit or triple-hit lymphoma) but not a candidate for more aggressive chemotherapy (such as cyclophosphamide, Oncovin \[vincristine\], doxorubicin, \[CODOX\]-methotrexate \[M\]- ifosfamide, Vepesid \[etoposide\], Ara-C \[cytarabine\] \[IVAC\]) * NOTE: Patients with a new diagnosis of concurrent DLBCL and an indolent lymphoma (previously undiagnosed, such as follicular lymphoma or marginal zone lymphoma) are eligible. However, patients with a known prior diagnosis of indolent lymphoma with new transformation to DLBCL (i.e., transformed lymphoma) are not eligible * Ann Arbor stages II (bulky disease, i.e., \>= 5 cm, or not a candidate for combined modality treatment with R-CHOP plus radiotherapy), III, or IV * Measurable disease (at least 1 lesion of \>= 1.5 cm in one diameter) as detected by computed tomography (CT) or the CT images of PET/CT. Skins lesions can be used if the area is \>= 2 cm in at…

What they're measuring

Maximum tolerated dose (MTD) of parsaclisib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (Phase I)

Timeframe: Up to 21 days

Complete metabolic response (CMR) rate (Dose Expansion)

Timeframe: Up to end of treatment (3-4 weeks after day 1 of cycle 6 [each cycle is 21 days])

Trial details

NCT IDNCT04323956

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-04

View on ClinicalTrials.gov More Ann Arbor Stage II Diffuse Large B-Cell Lymphoma trials