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

Trial Status: Complete

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.

Inclusion Criteria

  • 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 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 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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: COMPLETED
Contact: Robin Kemball
Phone: 310-267-5426
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
San Diego
UC San Diego Medical Center - Hillcrest
Status: COMPLETED
Contact: Thomas James Kipps
Phone: 858-822-5354

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: COMPLETED

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Chadi Nabhan
Phone: 773-834-7424

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Shams A. Shakil
Phone: 859-257-3379

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New Jersey

Hackensack
Hackensack University Medical Center
Status: CLOSED_TO_ACCRUAL

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: WITHDRAWN

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: COMPLETED

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: COMPLETED

This is an open-label, Phase 1/2a, multi-dose, multi-center trial of orally administered

cerdulatinib assessing safety, tolerability, and pharmacokinetic (PK) parameters conducted in

2 phases:

- Phase 1: Dose-escalation portion, during which participants will be enrolled to receive

a single-agent cerdulatinib at their assigned dose level starting at 15 milligrams (mg)

once daily (QD), administered in increasing doses until the maximum tolerated dose

(MTD)/maximum administered dose (MAD) is identified.

- Phase 2a: Consisting of planned cohorts based on cancer type. The participants will

receive single agent cerdulatinib at a starting dose of 35, 30, or 20 mg twice daily

(BID) for 28-day cycles except for one of the cohorts, the participants will receive

cerdulatinib plus intravenous (IV) rituximab at 375 mg/square meter (m^2) for 28-day

cycles.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Alexion Pharmaceuticals

  • Primary ID 13-601
  • Secondary IDs NCI-2014-00784
  • Clinicaltrials.gov ID NCT01994382