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Phase 1/2A Dose Escalation Study in CLL, SLL or NHL

Disease Information

Descriptive Information
Brief Title † Phase 1/2A Dose Escalation Study in CLL, SLL or NHL
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)
Brief Summary This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in patients with relapsed/refractory chronic lymphocytic leukemia or non-hodgkin lymphoma
Detailed Description This is an open-label, Phase 1/2a, multi dose, multi-center trial of orally administered cerdulatinib assessing safety, tolerability and PK parameters conducted in 2 phases: - Phase 1: Dose-escalation portion, during which 43 patients enrolled to receive a single-agent cerdulatinib at their assigned dose level starting at 15 mg QD, administered in increasing doses until the MTD/MAD is identified. - Phase 2a: Consisting of 6 planned cohorts of up to 40 patients each by cancer type. Five cohorts will receive single agent cerdulatinib at a starting dose of 30 mg BID for 28-day cycles. Cohort 2 receives cerdulatinib plus rituximab IV at 375 mg/m2.
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Maximum tolerated dose (MTD) of cerdulatinib in patients with relapsed/refractory CLL/SLL or B-cell NHL.
Secondary Outcome Measure † Frequency and severity of dose limiting toxicity as classified by Common Terminology Criteria for Adverse Events (CTCAEv4) by dose level. (Phase 1)
Condition † Follicular Lymphoma (FL/Indolent NHL) Aggressive NHL (a NHL) Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) T-cell Lymphoma (PTCL and CTCL) B-cell Non Hodgkin Lymphoma (NHL)
Intervention † Drugcerdulatinib (PRT062070)
Study Arms / Comparison Groups cerdulatinib (PRT062070) Intervention: Drug: cerdulatinib (PRT062070) or cerdulatinib (PRT062070) plus rituximab
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 283
Start Date † August 2013
Completion Date January 2018
Primary Completion Date January 2018
Eligibility Criteria † Inclusion Criteria: Phase 1 Specific Patient at least 18yrs of age with histologically confirmed CLL/SLL or B-cell Non-Hodgkin lymphoma (DLBCL, FL, MCL, MZL, lymphoplasmacytic lymphoma). Phase 2a Inclusion - Histological evidence: FL Grade 1-3A/iNHL, with relapsed or refractory disease (iNHL includes LPL/WM, MZL); aNHL, defined as DLBCL, FL Grade 3B, MCL, and transformed NHL with relapsed disease; CLL/SLL, PTCL, or CTCL (with MF/SS) with relapsed or refractory. - Received BCR and/or BCL2 inhibitors were intolerant or had relapsed/refractory disease afterwards. - Prior treatment for lymphoid malignancy for progressive /refractory disease - ≥ 1 prior regimen (min 2 cycles) with antibody conjugate, cytotoxic chemotherapy, or TKI alone or in combination. - Measureable disease defined as: ≥ 1 lesion ≥ 1.5 cm single dimension via CT, CT/PET with nodal or mass lesions; Quantifiable circulating tumor cells; or for Waldenström's macroglobulinemia presence of IgM l > 2X ULN; For CTCL: mSWAT > 0 - Ability to provide diagnostic reports General Inclusion - ECOG Score of 0 or 1. - Hematologic ANC > 1000/uL and platelet > 75,000/uL, - Serum creatinine of 60 mL/min - Bilirubin 20 mg QD prednisone (or equivalent) - Breastfeeding or pregnant (intention to become) females or participation in other clinical trials
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Portola Pharmaceuticals, 650.246.7000, Cerdulatinibclinical@portola.com
Location Countries † United States
Administrative Information
NCT ID † NCT01994382
Organization ID 13-601
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Portola Pharmaceuticals
Collaborators ††
Investigators † Study Director: Portola Study Director, Portola Pharmaceuticals
Information Provided By
Verification Date May 2016
First Received Date † November 8, 2013
Last Updated Date April 20, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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