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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01994382
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : July 26, 2019
Information provided by (Responsible Party):
Portola Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
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) Drug: Cerdulatinib (PRT062070) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 283 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : August 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: cerdulatinib (PRT062070)
Intervention: Drug: cerdulatinib (PRT062070) or cerdulatinib (PRT062070) plus rituximab
Drug: Cerdulatinib (PRT062070)

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of cerdulatinib in patients with relapsed/refractory CLL/SLL or B-cell NHL. [ Time Frame: 28-day cycles until end of treatment ]

Secondary Outcome Measures :
  1. Frequency and severity of dose limiting toxicity as classified by Common Terminology Criteria for Adverse Events (CTCAEv4) by dose level. (Phase 1) [ Time Frame: 28-day cycles until end of treatment ]
    Assessments: Antitumor activity of cerdulatinib as measured by ORR defined as CR+PR as measured by CT and CT/PET

  2. Assess antitumor activity of B-cell, T-cell NHL, or CLL/SLL, as a single agent and with rituximab for B-cell NHL (subtypes B-cell, T-cell NHL, or CLL/SLL) as single agent and with rituximab for B-cell NHL. [ Time Frame: 28-day cycles until end of treatment ]
    Assessments: Duration of response DOR, progression free survival PFS, time to treatment response TTR and lymph node response LNR, clinical benefit rate (CR+PR+SD)

  3. To further evaluate the PK profile of cerdulatinib in patients with specific subtypes of B-cell or T-cell NHL, alone or in combination with rituximab for B-cell NHL. [ Time Frame: 28-day cycles until end of treatment ]
    Assessments: (Cmax) and area under the plasma concentration versus time curve (AUC) of PRT602070.

  4. To further evaluate the PD of cerdulatinib in patients with specific subtypes of B-cell or T-cell NHL, alone or in combination with rituximab for B-cell NHL. [ Time Frame: 28-day cycles until end of treatment ]
  5. To assess tumor phenotype and genotype in relation to clinical response [ Time Frame: 28-day cycles until end of treatment ]
  6. To further evaluate the safety and tolerability of cerdulatinib in patients with specific subtypes of B-cell, T-cell NHL or CLL/SLL and the combination of cerdulatinib with rituximab in patients wtih B-cell NHL [ Time Frame: 28-day cycles until end of treatment ]
    Assessments: PE, vitals, laboratory values and AEs

  7. To evaluate the relationship between markers of inflammation with clinical outcome and overall health as determined by the Global Health Assessment. [ Time Frame: 28-day cycles until end of treatment ]
  8. To assess Minimal Residual Disease (MRD) status in CLL patients achieving a complete response/ complete response incomplete blood count recovery/partial response (CR/CRi/PR) by flow cytometry. [ Time Frame: 28-day cycles until end of treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 < 1.5 ULN or calculated CrCl of > 50 mL/min
  • Bilirubin < 20.0mg/dL (if Gilberts then < 2.5 mg/dL) and AST/AST < 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 90 days or active graft-versus-host treatment within 8 weeks of Day 1.
  • Prior therapy with SYK inhibitors.
  • Chronic treatment with strong CYP3A4 inhibitor/ inducer, acid reducing agent, Proton pump inhibitors
  • Known lymphomatous involvement of the CNS.
  • Persistent, unresolved NCI CTCAE v4.0 ≥ Grade 2, previous drug-related toxicity (except alopecia, erectile impotence, hot flashes, libido, neuropathy).
  • Prior monoclonal antibody, radioimmunoconjugate, antibody drug conjugate, phototherapy, radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any test agent within 3 weeks or for alemtuzumab 8 weeks of Day 1.
  • For CTCL: (TSEBT) within 12 weeks, or initiation of topical steroid, nitrogen mustard, or topical retinoid within 2 weeks. (Stable topical ≥ 4 weeks prior to Day 1 allowed).
  • Known carrier or infection for HIV/Hep B or C. HCV ab+ must be PCR-. HBV ab+ must be HBsAg- or undetectable DNA
  • Active infection requiring systemic treatment,
  • Significant GI disease, previous major gastric/bowel surgery, difficulty swallowing or malabsorption syndrome.
  • Major surgery within 4 weeks
  • Previous malignancies within 2 yrs. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01994382

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Contact: Portola Pharmaceuticals 650.246.7000

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Sponsors and Collaborators
Portola Pharmaceuticals
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Study Director: Portola Study Director Portola Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Portola Pharmaceuticals Identifier: NCT01994382     History of Changes
Other Study ID Numbers: 13-601
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: March 2019
Keywords provided by Portola Pharmaceuticals:
B Cell
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell