Phase 1 Dose Escalation Study in Chronic Lymphocytic Leukemia and Non-hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Portola Pharmaceuticals
Information provided by (Responsible Party):
Portola Pharmaceuticals Identifier:
First received: November 8, 2013
Last updated: November 9, 2015
Last verified: November 2015
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

Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
B-cell Non Hodgkin Lymphoma (NHL)
Drug: cerdulatinib (PRT062070)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open-Label, Multi-Dose, Dose Escalation Study Of PRT062070 In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Or B-Cell Non Hodgkin Lymphoma (NHL)

Resource links provided by NLM:

Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of cerdulatinib in patients with relapsed/refractory CLL/SLL or B-cell NHL. [ Time Frame: Approximately 28 days (baseline to end of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of dose limiting toxicity (as classified by Common Terminology Criteria for Adverse Events (CTCAEv4) by dose level. [ Time Frame: Approximately 28 days ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of PRT602070. [ Time Frame: Baseline to day 28 ] [ Designated as safety issue: No ]
  • Tumor response rate by day 56 [ Time Frame: 2 cycles ] [ Designated as safety issue: No ]
  • Measurement of inflammation markers by day 28 [ Time Frame: End of cycle 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: August 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cerdulatinib (PRT062070)

- cerdulatinib (PRT062070) dose escalation study

Approximately 28 patients are expected to be enrolled in the dose escalation (Part 1) portion of the study

- cerdulatinib (PRT062070) expansion study

Up to 80 additional patients may be enrolled in the expansion phase (Part 2) of the study

Drug: cerdulatinib (PRT062070)
cerdulatinib oral pill


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must have a diagnosis of CLL/SLL or B-cell Non-Hodgkin lymphoma (Diffuse Large B-cell lymphoma [DLBCL], follicular lymphoma [FL], mantle cell lymphoma [MCL], MALT lymphoma, marginal zone lymphoma [MZL], lymphoplasmacytic lymphoma).
  • ECOG Performance Score of 0 or 1.
  • 18 years or older, of either sex, and of any race.
  • Adequate hematologic, renal and hepatic function

Exclusion Criteria:

  • Patient has Richter's syndrome.
  • Prior allogeneic stem cell transplant.
  • Patient has received prior therapy with a SYK inhibitor.
  • Patient requires treatment with a strong CYP3A4 inhibitor or inducer (Appendix C) or with a proton pump inhibitor (PPI) or Acid Reducing Agent (ARA).
  • Patient has known lymphomatous involvement of the central nervous system (CNS).
  • Known hypersensitivity to any of the components of cerdulatinib.
  • Patient has persistent, unresolved CTCAE v4.0 ≥Grade 2 drug-related toxicity associated with previous treatment.
  • Known HIV, hepatitis B or hepatitis C infection or is known to be a carrier of hepatitis B or C.
  • Active infection requiring systemic treatment. Prophylactic antimicrobial treatment is permitted
  • Significant gastrointestinal disease that may interfere with absorption of the study drug or that predisposes him/her to GI adverse effects, or has had major gastric or bowel surgery.
  • Patient has undergone major surgery or received radiation therapy within 2 weeks prior to first study drug administration.
  • History (within 2 years prior to first study drug administration) of another malignancy unless malignancy treated with curative intent and likelihood of relapse is small (<5% in 2 years). History of squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix may be enrolled.
  • Patient is receiving systemic steroids at doses greater than the equivalent of prednisone, 20 mg daily
  • Female and is breast-feeding, pregnant or intends to become pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01994382

Contact: Portola Pharmaceuticals 650.246.7000

United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Sarasota, Florida, United States, 34232
United States, Illinois
Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
Not yet recruiting
Baltimore, Maryland, United States, 21229
United States, Missouri
Active, not recruiting
St. Louis, Missouri, United States, 63130
United States, New York
New York, New York, United States, 10065
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Portola Pharmaceuticals
Study Director: Alice Sabalvaro-Torres Portola Pharmaceuticals
  More Information

Responsible Party: Portola Pharmaceuticals Identifier: NCT01994382     History of Changes
Other Study ID Numbers: 13-601 
Study First Received: November 8, 2013
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
B Cell

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on May 01, 2016