Clinical Trials /

Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

NCT02309580

Description:

This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1 clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see what effect the drug has on the patient and the disease.

Related Conditions:
  • Peripheral T-Cell Lymphoma
  • Primary Cutaneous T Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma
  • Official Title: A Multicenter Phase I Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 14-227
  • NCT ID: NCT02309580

Conditions

  • T-cell Lymphoma
  • Relapsed and Refractory T-cell Lymphoma

Interventions

DrugSynonymsArms
IbrutinibIbrutinib

Purpose

This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1 clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see what effect the drug has on the patient and the disease.

Trial Arms

NameTypeDescriptionInterventions
IbrutinibExperimentalThis will be a standard dose-escalation study to determine the MTD of ibrutinib in relapsed/refractory PTCL or CTCL. At each dose 6 patients with TCL (PTCL or CTCL) will be enrolled. The first 6 patients will be enrolled at dose level 1. Dose escalation to the next dose level will proceed after DLT assessment of all 6 patients at the end of cycle 1 (28-days).
  • Ibrutinib

Eligibility Criteria

        Inclusion Criteria:

          -  Pathology confirmed relapsed or refractory T-cell lymphoma (PTCL and stage >IBCTCL) at
             treating institution

          -  Relapse or progression after at least 1 systemic therapy

          -  Age ≥18 years at the time of signing the informed consent form

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Previous systemic anti-cancer therapy must have been discontinued at least 3 weeks
             prior to treatment in this study. If there is progression of disease on that therapy
             and all adverse effects have resolved to Grade 1 or baseline, in which case 2 weeks is
             acceptable

          -  Previous radiation, hormonal therapy, and surgery must have been discontinued at least
             2 weeks prior to treatment in this study and adverse effects must have resolved. Lymph
             node or other diagnostic biopsy within 2 weeks is not considered exclusionary

          -  Systemic corticosteroids are permissible in the following circumstances:

          -  Short course systemic corticosteroids for disease control, improvement of performance
             status or non-cancer indication (≤ 7 days) must have been discontinued at least 7 days
             prior to study treatment.

          -  Ongoing administration of a stable dose of corticosteroid therapy (previously received
             for ≥ 30 days) is permissible provided there is evidence of measurable disease and
             there will be no increase in steroid dose during the clinical trial

          -  ECOG performance status of ≤ 2 at study entry

          -  Patients who have undergone autologous stem cell transplant > 6 months prior are
             eligible

          -  Patients who have undergone allogeneic stem cell transplant > 12 months, without
             active graft-versus-host-disease, and not on immunosuppression for prevention of
             graft-versus-host disease are eligible

          -  Laboratory test results within these range:

          -  Adequate hematologic function with screening laboratory assessment defined as:

          -  Absolute neutrophil count >1,000 cells/mm3 (1.0 x 10^9/L)

          -  Platelet count >75,000 cells/mm3 (75 x 10^9/L), if thrombocytopenia is due to bone
             marrow involvement platelet count must be ≥ 50,000 cells/mm3

          -  Hemoglobin >8.0 g/dL

          -  Adequate hepatic and renal function with screening laboratory assessment defined as:

          -  Serum aspartate transaminase (AST) or alanine transaminase (ALT)

             ≤2.5 x upper limit of normal (ULN)

          -  Creatinine <2.0 x ULN or Estimated Glomerular Filtration Rate GFR [Cockcroft-Gault] >
             30 mL/min.

          -  Bilirubin <1.5 x ULN [unless bilirubin rise is due to Gilbert's syndrome (as defined
             by >80% unconjugated hyperbilirubinemia) or of nonhepatic origin]

          -  Females of childbearing potential (FCBP)† must have a negative serum pregnancy test
             and agree to use appropriate methods of birth control

        Exclusion Criteria:

          -  Patients who have a standard curative option for their lymphoid malignancy at current
             state of disease are excluded. For eligibility on this trial, allogeneic stem cell
             transplantation is not considered a standard curative option

          -  Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc.)
             within 28 days of the first dose of study drug

          -  Recent infection requiring intravenous anti-infective treatment that was completed ≤14
             days before the first dose of study drug

          -  Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia

          -  Treatment with warfarin or other Vitamin K antagonists (eg, phenprocoumon)

          -  Any life-threatening illness, medical condition, or organ system dysfunction that, in
             the opinion of the investigator, could compromise the subject's safety or put the
             study outcomes at undue risk

          -  Unwilling or unable to participate in all required study evaluations and procedures.

          -  Unable to understand the purpose and risks of the study and to provide a signed and
             dated informed consent form (ICF)

          -  Currently active, clinically significant cardiovascular disease, such as uncontrolled
             arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart
             Association Functional Classification; or a history of myocardial infarction, unstable
             angina, or acute coronary syndrome within 6 months prior to enrollment

          -  Unable to swallow capsules, malabsorption syndrome, disease significantly affecting
             gastrointestinal function, resection of the stomach or small bowel, symptomatic
             inflammatory bowel disease or ulcerative colitis, or partial or complete bowel
             obstruction

          -  Pregnant females (Lactating females must agree not to breast feed while taking
             ibrutinib

          -  Prior use of ibrutinib

          -  Known seropositive and requiring anti-viral therapy for human immunodeficiency virus
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) defined by PCR.

          -  Active concurrent malignancy requiring active therapy

          -  Known central nervous system or meningeal involvement (in the absence of symptoms
             investigation into central nervous system involvement is not required)

          -  Patients who require treatment with a strong cytochrome P450 (CYP) 3A inhibitor
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated does
Time Frame:1 year
Safety Issue:
Description:evaluate the safety and toxicities of ibrutinib in patients with relapsed/refractory Tcell lymphoma (PTCL and CTCL) as defined by CTCAE version 4.

Secondary Outcome Measures

Measure:overall response rate (ORR)
Time Frame:1 year
Safety Issue:
Description:Response and progression of disease will be evaluated in this study using the revised response criteria for malignant lymphoma with incorporation of PET/CT.33 Response in subjects with CTCL will be assessed using a specific skin scoring system with mSWAT and incorporation of measurements of extracutaneous disease.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Ibrutinib
  • 14-227

Last Updated

November 6, 2019