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Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
Trial ID: NCT01994382
This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.
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)
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
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