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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCerdulatinib and Rituximab

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 5, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Alexion Pharmaceuticals, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Alexion Pharmaceuticals, Inc.
Interventions being studied: Drug: Cerdulatinib; Biological: Rituximab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Recurrent or relapsed→Resistant or refractory→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 disease
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 \>75,000/uL
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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Study locationHuntsville, Alabama
Study locationGilbert, Arizona
Study locationLos Angeles, California
Study locationPalo Alto, California
Study locationWashington D.C., District of Columbia
Study locationGainesville, Florida
Study locationSarasota, Florida
Study locationLawrenceville, Georgia
Study locationChicago, Illinois
Study locationLouisville, Kentucky
Study locationBaltimore, Maryland
Study locationAnn Arbor, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 5, 2022. Always confirm current availability with the study team.

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