Overview

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

Status:
Active, not recruiting
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in patients with relapsed/refractory chronic lymphocytic leukemia or non-hodgkin lymphoma
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Portola Pharmaceuticals
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.

- 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