RECRUITING

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

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Conditions

NK-Cell LymphomaNK-Cell LeukemiaPeripheral T Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study Using Induction Chemo-immunotherapy Followed by Consolidation With Reduced Toxicity Conditioning and Allogenic Stem Cell Transplant in Advanced Stage Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents and Young Adults; A NK/T-Cell Lymphoma/Leukemia Consortium Study

Quick Facts

Study Start:2019-03-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03719105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 31 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must weigh at least 10 kilograms at the time of the study enrollment.
  2. * Diagnosis
  3. * Aggressive NK cell leukemia (ICD-O code 9948/3)
  4. * Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
  5. * Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
  6. * Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)
  7. * Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)
  8. * Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)
  9. * 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).
  10. * Organ Function Requirements
  11. * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
  12. * ALT (SGPT) \< 3 x ULN for age.
  13. * Shortening fraction of ≥ 27% by echocardiogram, or
  14. * Ejection fraction of ≥ 50% by radionuclide angiogram.
  1. * Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)
  2. * Patients with active CNS disease.
  3. * Patients with stage I or stage II disease (See Appendix III for Staging).
  4. * Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
  5. * 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.
  6. * Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
  7. * Lactating females, unless they have agreed not to breastfeed their infants.
  8. * Patients with Down syndrome.
  9. * 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.
  10. * 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.
  11. * 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).

Contacts and Locations

Study Contact

Ana Xavier
CONTACT
(205) 638-6763
axavier@peds.uab.edu
Lauren Harrison
CONTACT
6172857844
lauren_harrison@nymc.edu

Principal Investigator

Mitchell Cairo, MD
STUDY_DIRECTOR
New York Medical College

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35223
United States
Children's Hospital Orange County
Orange, California, 92968
United States
University of California San Francisco
San Francisco, California, 94143
United States
Helen De Vos
Grand Rapids, Michigan, 49503
United States
New York Medical College
Valhalla, New York, 10595
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States

Collaborators and Investigators

Sponsor: New York Medical College

  • Mitchell Cairo, MD, STUDY_DIRECTOR, New York Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-03-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • NK-Cell Lymphoma
  • NK-Cell Leukemia
  • Peripheral T Cell Lymphoma