phase 1/2a dose escalation study in participants with cll, sll, or nhl

Conditions: Follicular Lymphoma (FL/Indolent NHL); Aggressive NHL (a NHL); Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL); T-cell Lymphoma (PTCL and CTCL); B-cell Non Hodgkin Lymphoma (NHL)

Summary: this study will identify the highest dose, and assess the safety, of cerdulatinib (prt062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.

this is an open-label, phase 1/2a, multi-dose, multi-center trial of orally administered cerdulatinib assessing safety, tolerability, and pharmacokinetic (pk) parameters conducted in 2 phases: * phase 1: dose-escalation portion, during which participants will be enrolled to receive a single-agent cerdulatinib at their assigned dose level starting at 15 milligrams (mg) once daily (qd), administered in increasing doses until the maximum tolerated dose (mtd)/maximum administered dose (mad) is identified. * phase 2a: consisting of planned cohorts based on cancer type. the participants will receive single agent cerdulatinib at a starting dose of 35, 30, or 20 mg twice daily (bid) for 28-day cycles except for one of the cohorts, the participants will receive cerdulatinib plus intravenous (iv) rituximab at 375 mg/square meter (m\^2) for 28-day cycles.

Eligibility criteria:
inclusion criteria: phase 1 inclusion • participant at least 18 years of age with histologically confirmed cll/sll or b-cell non-hodgkin lymphoma (diffuse large b-cell lymphoma \[dlbcl\], fl, mantle cell lymphoma \[mcl\], marginal zone lymphoma \[mzl\], lymphoplasmacytic lymphoma). phase 2a inclusion * histological evidence: fl grade 1-3a, with relapsed or refractory disease; aggressive nhl (anhl), defined as dlbcl, fl grade 3b, mcl, and transformed nhl with relapsed disease; cll/sll, peripheral t-cell lymphoma (ptcl), or cutaneous t-cell lymphoma (ctcl) (with mycosis fungoides \[mf\]/sézary syndrome \[ss\]) with relapsed or refractory disease * received b-cell receptor (bcr) and/or bcl2 inhibitors and were intolerant or had relapsed/refractory disease afterwards * prior treatment for lymphoid malignancy for progressive /refractory disease * ≥1 prior regimen (minimum 2 cycles) with antibody conjugate/cytotoxic chemotherapy. * measurable disease defined as: ≥1 lesion that measures ≥1.5 centimeter (cm) single dimension via computed tomography (ct), ct/positive-emission tomography (pet) with nodal or mass lesions; quantifiable circulating tumor cells; and for ctcl: modified severity weighted assessment tool (mswat) \>0 * ability to provide diagnostic reports general inclusion * eastern cooperative oncology group (ecog) score of 0 or 1 * hematologic absolute neutrophil count (anc) \>1000/microliter (ul) and platelet \>75,000/ul * creatinine levels as specified by investigator * bilirubin \<2.0 mg/deciliter \[dl\] (if gilberts then \<2.5 mg/dl) and aspartate aminotransferase (ast)/alanine aminotransferase (alt) \<2.5\*uln exclusion criteria: * richter's syndrome, burkitt's lymphoma, or burkitt-like lymphoma (transformed dlbcl from follicular nhl are eligible) * prior transplant with stem cell infusion within 90 days of day 1 or active graft-versus-host treatment within 8 weeks of day 1 * prior therapy with spleen tyrosine kinase (syk) inhibitors * chronic treatment with strong cyp3a4 inhibitor/inducer * known lymphomatous involvement of the central nervous system (cns) * persistent, unresolved national cancer institute (nci) common toxicity criteria for adverse events (ctcae) version 5.0 ≥grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy). * prior monoclonal antibody (including alemtuzumab), radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks of day 1 * for ctcl: (total skin electron beam therapy \[tsebt\]) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. stable topical regimen for ≥4 weeks prior to day 1 allowed. * known carrier or infection for human immunodeficiency virus (hiv)/hepatitis b or c. if hepatitis c virus (hcv) antibody (ab)+, must be polymerase chain reaction (pcr)- to be eligible. if hepatitis b virus (hbv) ab+, must be hepatitis b surface antigen (hbsag)- or undetectable hbv deoxyribonucleic acid (dna) to be eligible. * active infection requiring systemic treatment, * significant gastrointestinal (gi) disease, previous major gastric/bowel surgery, difficulty swallowing, or malabsorption syndrome * major surgery within 4 weeks * previous malignancies within 2 years unless relapse risk is small (\<5%). * current use of systemic steroids \>20 mg qd prednisone (or equivalent) * breastfeeding or pregnant (intention to become) females or participation in other clinical trials

Keywords: leukemia lymphocytic chronic b cell