Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL

Not Recruiting

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.

Official Title

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)

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Michael Khodadoust
Michael Khodadoust

Assistant Professor of Medicine (Oncology) and of Dermatology


Inclusion Criteria:

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

General Inclusion

   - 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

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 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
   clinical trials


drug: Cerdulatinib

biological: Rituximab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sydney Yee

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