Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/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

Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma

Official Title

Induction Chemo-Immunotherapy Followed by Reduced Toxicity Conditioning and Allogeneic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-cell or NK Lymphoma/Leukemia

Brief Summary

      Patients are in 2 cohorts:

      Cohort 1: dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide (modified
      SMILE) chemotherapy regimen alone and pembrolizumab in children, adolescents, and young
      adults with advanced stage NK lymphoma and leukemia Cohort 2: combining pralatrexate (PRX)
      (Cycles 1, 2, 4, 6) and brentuximab vedotin (BV) (Cycles 3, 5) to cyclophosphamide,
      doxorubicin, and prednisone in children, adolescent, and young adults with advanced
      peripheral T-cell lymphoma (non-anaplastic large cell lymphoma or non-NK lymphoma/leukemia) .

      Both groups proceed to allogeneic stem cell transplant with disease response.

Study Phase

Early Phase 1

Study Type


Primary Outcome

overall response rate

Secondary Outcome

 event free survival


NK-Cell Lymphoma



Study Arms / Comparison Groups

 Cohort 1
Description:  Patients with aggressive NK cell leukemia or stage III or IV extranodal NK/T-cell lymphoma, nasal type.
Chemotherapy Regimen:
mSMILE: Methotrexate Day 1, Ifosfamide Days 2-4, Dexamethasone Days 2-4, Etoposide Days 2-4, calaspargase pegol Day 8. For patients in CR and no available allogeneic SCT can receive up to 2 additional cycles of mSMILE.
Pembrolizumab: For patients in PR/MR/NR/PD after 2 cycles of mSMILE.
Allogeneic Stem Cell Transplant if donor available and not in PD.


* 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


Estimated Enrollment


Start Date

March 1, 2019

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must weigh at least 10 kilograms at the time of the study enrollment.

          -  Diagnosis

        Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms:

        COHORT 1

          -  Aggressive NK cell leukemia (ICD-O code 9948/3)

          -  Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2

          -  Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)

          -  Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)

          -  Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)

          -  Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)

          -  Other mature T- and NK-cell neoplasm histologies will considered after case-by-case
             discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have
             stage III or IV disease (See Appendix III for Staging).

               -  Organ Function Requirements

        Adequate liver function defined as:

          -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.

          -  ALT (SGPT) < 3 x ULN for age.

        Adequate cardiac function defined as:

          -  Shortening fraction of ≥ 27% by echocardiogram, or

          -  Ejection fraction of ≥ 50% by radionuclide angiogram.

        Adequate pulmonary function defined as:

        • Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at
        rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry > 92%
        while breathing room air unless current dysfunction is due to the lymphoma, in which case
        the patient is eligible.

        Exclusion Criteria:

          -  Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)

          -  Patients with active CNS disease.

          -  Patients with stage I or stage II disease (See Appendix III for Staging).

          -  Patients who have received any prior cytotoxic chemotherapy for the current diagnosis
             of NHL.

          -  Previous steroid treatment and/or radiation treatment are not allowed unless they are
             used for emergency management. Patients who have received emergency irradiation and/or
             steroid therapy will be eligible only if started on protocol therapy not more than one
             week from the start of radiotherapy or steroids.

          -  Female patients who are pregnant. Pregnancy tests must be obtained in girls who are
             post menarchal.

          -  Lactating females, unless they have agreed not to breastfeed their infants.

          -  Patients with Down syndrome.

          -  Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2
             ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with
             narrow therapeutic indices (See Appendix V). The topical use of these medications (if
             applicable) is allowed.

          -  Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving
             drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment
             (See Appendix V). The topical use of these medications (if applicable) is allowed.

          -  Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs
             that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See
             Appendix V).




1 Year - 31 Years

Accepts Healthy Volunteers



Mitchell Cairo, MD, (205) 638-6763, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID

NYMC 575

Responsible Party

Principal Investigator

Study Sponsor

New York Medical College


 University of Alabama at Birmingham

Study Sponsor

Mitchell Cairo, MD, Study Director, New York Medical College

Verification Date

September 2021