A Phase 1/2A Open-Label, Multi-Dose, Multi-Center Escalation and Exploratory Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or B Cell or T Cell Non-Hodgkin Lymphoma (NHL)

Purpose

The primary objective is to determine the maximum tolerated dose/ maximum administered dose of cerdulatinib in patients with relapsed/refractory chronic lymphocytic leukemia, small lymphocytic lymphoma or B-cell non Hodgkin lymphoma.The primary objective is to determine the maximum tolerated dose/ maximum administered dose of cerdulatinib in patients with relapsed/refractory chronic lymphocytic leukemia, small lymphocytic lymphoma or B-cell non Hodgkin lymphoma.

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.
  • 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 > 50 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

Keywords

Non-Hodgkin Lymphoma, cerdulatinib, maximum tolerated dose (MTD)

Principal Investigator

Nam H Dang, M.D.

Department

MD-HEMATOLOGY/ONCOLOGY

Contact Information

nam.dang@medicine.ufl.edu

(352) 273-7832


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