Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-31
SponsorNew York Medical College
About this trial
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.
Eligibility criteria
Qualifiers
Patients must weigh at least 10 kilograms at the time of the study enrollment.
Diagnosis
Aggressive NK cell leukemia (ICD-O code 9948/3)
Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Methotrexate
- pralatraxate,
- Ifosfamide
- Dexamethasone
- Etoposide
- calaspargase pegol
- cyclophosphamide
- Doxorubicin
- Prednisone
- Brentuximab Vedotin
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
New York Medical College
Lead sponsor
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov