Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

Learn more about:
Related Clinical Trial
A Phase 1, Study of CD4-Targeted Chimeric Antigen Receptor T-Cells (CD4- CAR-T) in Subjects With Relapsed or Refractory T-Cell Lymphoma CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma. A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell and Indolent B-Cell Lymphomas Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas AMG 319 Lymphoid Malignancy FIH Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) PD-1 Knockout EBV-CTLs for Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies Tandem Auto-Allo Transplant for Lymphoma Anti-CD30 CAR-T Therapy in Patients With Refractory/Relapsed Lymphocyte Malignancies Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) and Alemtuzumab for People With Refractory or Relapsed Chronic and Acute Adult T-cell Leukemia (ATL) Study of AZD5991 in Relapsed or Refractory Haematologic Malignancies. p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies A Phase II Study Of Imtox-25 In Adults With Refractory/Relapsed Cd25 Positive Adult T Cell Leukemia/Lymphoma Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas CD4CAR for CD4+ Leukemia and Lymphoma Pembrolizumab for T/NK-cell lymphomasNK-cell Lymphomas Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma Anti-CD7 U-CAR-T Cell Therapy for T/NK Cell Hematologic Malignancies Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma A Study for Patients With Non-Hodgkin’s Lymphomas High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma Allo-HSCT as First-line Consolidation in High-risk PTCL A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas An Open Label, International, Multi-centre, Phase I/IIa Study of Lenalidomide (Revlimid) and Romidepsin (Istodax) for Relapsed /Refractory Hodgkin Lymphoma, Mature T-cell Lymphoma and Multiple Myeloma. (RId Study) A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low ( T-cell Brazil: Prospective Collection of Data in T-cell Lymphomas Patients A-dmDT390-bisFv(UCHT1) Immunotoxin Therapy for Patients With Cutaneous T-Cell Lymphoma (CTCL) Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL) Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL) ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas Phase I Dose-finding and Preliminary Efficacy Study of the Istodax® in Combination With Doxil® for the Treatment of Adults With Relapsed or Refractory Cutaneous T-cell Lymphoma Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma Bendamustine, Carboplatin and Dexamethasone (BCD) for Refractory or Relapsed Peripheral T-cell Lymphoma Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas Helical Irradiation of Total Skin (HITS) for T Cell Lymphoma Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL) CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia A Multicenter Clinical Trial of Daratumumab in Combination With Gemcitabine, Dexamethasone and Cisplatin in Patients With Relapsed/Refractory CD38 Positive PTCL-NOS, Angioimmunoblastic T-cell Lymphoma AITL and Other Nodal Lymphomas of T Follicular Helper Cells Origin Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma A Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin’s Lymphoma HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma Gemcitabine in NK/T Cell Lymphoma A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma Trial of Endostar Combined With CHOPT for T Cell Lymphoma Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma LAMPP Trial for Peripheral and Cutaneous T-Cell Lymphoma LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

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

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated does

Secondary Outcome

 overall response rate (ORR)

Condition

T-cell Lymphoma

Intervention

Ibrutinib

Study Arms / Comparison Groups

 Ibrutinib
Description:  This 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).

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

19

Start Date

January 2015

Completion Date

December 2022

Primary Completion Date

December 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anita Kumar, MD, 212-639-2668, 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02309580

Organization ID

14-227


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 Ohio State University

Study Sponsor

Anita Kumar, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

November 2020