Phase 1/2A Dose Escalation Study in CLL, SLL or NHL

Disease (cancer type)

Lymphoma

Contact information

  • North Florida / Jacksonville: Rhonda Calhoun (904) 427-1217

Patient Selection Criteria

Ages Eligible for Study: 18 Years and older (Adult, Senior) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Phase 1 Specific Patient at least 18yrs of age with histologically confirmed CLL/SLL or B-cell Non-Hodgkin lymphoma (DLBCL, FL, MCL, MZL, lymphoplasmacytic lymphoma). Phase 2a Inclusion Histological evidence: FL Grade 1-3A/iNHL, with relapsed or refractory disease (iNHL includes LPL/WM, MZL); aNHL, defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, PTCL, or CTCL (with MF/SS) with relapsed or refractory. Received BCR and/or BCL2 inhibitors were intolerant or had relapsed/refractory disease afterwards. Prior treatment for lymphoid malignancy for progressive /refractory disease ≥ 1 prior regimen (min 2 cycles) with antibody conjugate, cytotoxic chemotherapy, or TKI alone or in combination. Submission of formalin-fixed block or 10 slides from lymph node or biopsies if able. Measureable disease defined as: ≥ 1 lesion ≥ 1.5 cm single dimension via CT, CT/PET with nodal or mass lesions; Quantifiable circulating tumor cells; or for Waldenström's macroglobulinemia presence of IgM l > 2X ULN; For CTCL: mSWAT > 0 Ability to provide diagnostic reports General Inclusion ECOG Score of 0 or 1. Hematologic ANC > 1000/uL and platelet > 75,000/uL, Serum creatinine of < 1.5 ULN or calculated CrCl of > 60 mL/min Bilirubin < 20.0mg/dL (if Gilberts then < 2.5 mg/dL) and AST/AST < 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 90 days or active graft-versus-host treatment within 8 weeks of Day 1. Prior therapy with SYK inhibitors. Chronic treatment with strong CYP3A4 inhibitor/ inducer, acid reducing agent, Proton pump inhibitors Known lymphomatous involvement of the CNS. Persistent, unresolved NCI CTCAE v4.0 ≥ Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy). Prior monoclonal antibody, radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks or for alemtuzumab 8 weeks of Day 1. For CTCL: (TSEBT) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. (Stable topical ≥ 4 weeks prior to Day 1 allowed). Known carrier or infection for HIV/Hep B or C. HCV ab+ must be PCR-. HBV ab+ must be HBsAg- or undetectable DNA Active infection requiring systemic treatment, Significant GI disease, previous major gastric/bowel surgery, difficulty swallowing or malabsorption syndrome. Major surgery within 4 weeks Previous malignancies within 2 yrs. 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

Research sponsor

Portola Pharmaceuticals

Reference ID#

Portola 13-601

State(s)

  • Florida

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