Trial Search Results

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

The drug being studied is PRT062070; it is also called cerdulatinib. It is being evaluated as a possible new treatment for CLL, SLL, and B-cell NHL, and T cell NHL. PRT062070 is not approved by the Food and Drug Administration (FDA). The primary purpose of the Phase 1 portion of this study is to assess safety and maximum amount of drug that can be taken. Phase 1 is now closed to enrollment. The primary purpose of the Phase 2a portion of this study is to assess safety and the activity of the study drug in patients who have CLL, SLL, or B-cell NHL, or T-cell NHL.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Portola Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: Cerdulatinib (PRT062070)

Phase:

Phase 1/Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sydney Yee
650-721-6118
Not Recruiting