Nivolumab in Combination With GDP/ L-asparaginase in NK/ 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

Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma

Official Title

A Pilot Study of Nivolumab in Combination With GDP (Gemcitabine, Dexamethasone, Cisplatin)/ L-asparaginase in Patients With Advanced Stage or Relapsed/ Refractory Natural-killer/ T-cell Lymphoma

Brief Summary

      This is a pilot study investigating the role of nivolumab, a PD-1 inhibitor, in the treatment
      of advanced stage or relapsed/refractory NKTL. Patients who have received PD-1 inhibitors
      will be excluded from this study.

      Patients who have a complete response or good partial response to nivolumab during initial
      phase will continue to be treated with nivolumab. Patients who have a partial response,
      stable disease, and progressive disease to nivolumab during initial phase will be treated
      with the combination of nivolumab and GDP/L-asparaginase.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of patients with complete response and partial response to treatment

Secondary Outcome

 Progression-free survival

Condition

NK/T Cell Lymphoma

Intervention

IV Nivolumab

Study Arms / Comparison Groups

 Nivolumab
Description:  After 4 doses of nivolumab, if the patient has complete responses (CR) or good partial response (PR), the patient will continue on nivolumab until disease progression, unacceptable toxicities, or discontinuation of treatment. During PET4-directed treatment with single agent nivolumab, if patient has PD, they will proceed to the Nivo+GDP/L-aspa arm.

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

0

Start Date

December 12, 2019

Completion Date

June 12, 2020

Primary Completion Date

June 12, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Signed written informed consent

               -  Subjects must have signed and dated and IRB-approved written consent form in
                  accordance with regulatory and institutional guidelines. This must be obtained
                  before the performance of any protocol-related procedures that are not part of
                  normal subject care

               -  Subjects must be willing and able to comply with scheduled visits, treatment
                  schedule, laboratory tests and other requirements of the study

          -  Target population

               -  All subjects must have histologically confirmed extranodal natural-killer/T-cell
                  lymphoma (NKTL)

               -  Subjects must have

                    -  previously untreated stage III or IV NKTL, OR

                    -  relapsed/refractory NKTL who has received at least 2 cycles of one prior
                       regimen or previous radiotherapy administered with curative intent and one
                       of the following:

                         -  Failed to achieve at least a partial response

                         -  Failed to achieve a complete response at the end of planned therapy
                            with curative intent

                         -  Progressed after initial response

               -  Age ≥ 21 years

               -  ECOG Performance status 0 - 2

               -  Subjects must have laboratory test results within these ranges:

                    -  Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L

                    -  Platelet count ≥ 75 x10^9/L

                    -  Creatinine clearance ≥ 40ml/min

                    -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN). Higher levels are
                       acceptable if these can be attributed to active haemolysis or ineffective
                       erythropoiesis

                    -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x ULN

          -  Women of childbearing potential (WOCBT) must agree to use dual methods of
             contraception and have a negative serum or urine pregnancy test prior study treatment.
             Male patients must use an effective barrier method of contraception if sexually active
             with a WOCBT

        Exclusion Criteria:

          -  Previous treatment with an anti PD-1, anti PD-L1, anti PD-L2, anti-CD137, or
             anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell
             co-stimulation or checkpoint pathways

          -  Previous GDP therapy

          -  Previous serious hypersensitivity reaction or symptomatic pancreatitis from
             L-asparaginase

          -  Uncontrolled central nervous (CNS) disease

          -  Uncontrolled hepatitis B or C

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS)

          -  All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue
             must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration
             of study drug

          -  Subjects with > grade 1 peripheral neuropathy

          -  Any serious or uncontrolled medical disorder, autoimmune disorder or active infection
             that, in the opinion of the investigator, may increase the risk associated with study
             participation, study drug administration or would impair the ability fo the subject to
             receive the study drug

          -  Subjects who have had prior malignancies (other than NKTL) for ≤5 year with exception
             of currently treated basal cell, squamous cell carcinoma of the skin or carcinoma "in
             situ" of the cervix or breast.

          -  Subjects who have had other anti-cancer therapy including radiation or experimental
             drug therapy within 28 days of enrollment

          -  Subjects with known allergies or hypersensitivities to the study drugs

          -  Prisoners or subjects who are involuntarily incarcerated

          -  Subjects who are compulsorily detained for treatment of either a psychiatric or
             physical (e.g., infectious disease) illness

          -  Pregnant women or women who are breastfeeding are excluded from this study

        Inclusion of women and minorities:

        Men and women of all ethnic groups are eligible for this study
      

Gender

All

Ages

21 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Tiffany Tang, MD, , 

Location Countries

Singapore

Location Countries

Singapore

Administrative Informations


NCT ID

NCT04230330

Organization ID

CA209-8R6


Responsible Party

Sponsor

Study Sponsor

National Cancer Centre, Singapore

Collaborators

 Bristol-Myers Squibb

Study Sponsor

Tiffany Tang, MD, Principal Investigator, National Cancer Centre, Singapore


Verification Date

November 2020