Trial Search Results
Phase 1/2a Dose Escalation Study in Participants With 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.
Collaborator: Portola Pharmaceuticals
- Drug: Cerdulatinib
- Biological: Rituximab
Phase 1/Phase 2
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
- 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
- Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1
- Hematologic absolute neutrophil count (ANC) >1000/microliter (uL) and platelet
- 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study