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

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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

Interventional


Primary Outcome

overall response rate

Secondary Outcome

 event free survival

Condition

NK-Cell Lymphoma

Intervention

Methotrexate

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.

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

40

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).
      

Gender

All

Ages

1 Year - 31 Years

Accepts Healthy Volunteers

No

Contacts

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

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03719105

Organization ID

NYMC 575


Responsible Party

Principal Investigator

Study Sponsor

New York Medical College

Collaborators

 University of Alabama at Birmingham

Study Sponsor

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


Verification Date

September 2021