Actively Recruiting
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Led by New York Medical College · Updated on 2025-08-08
40
Participants Needed
6
Research Sites
513 weeks
Total Duration
On this page
Sponsors
N
New York Medical College
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must weigh at least 10 kilograms at enrollment
- Newly diagnosed with mature T- and NK-cell neoplasms
- Cohort 1 includes aggressive NK cell leukemia or extranodal NK/T-cell lymphoma, nasal type
- Cohort 2 includes enteropathy-associated T-cell lymphoma, hepatosplenic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma
- Patients with lymphoma must have stage III or IV disease
- Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal, ALT < 3 x upper limit of normal
- Adequate cardiac function: shortening fraction ≥ 27% or ejection fraction ≥ 50%
- Adequate pulmonary function: no resting dyspnea, no exercise intolerance, pulse oximetry > 92% on room air unless due to lymphoma
You will not qualify if you...
- Anaplastic Large Cell Lymphoma (ALK positive or negative)
- Active central nervous system disease
- Stage I or II disease
- Prior cytotoxic chemotherapy for current NHL diagnosis
- Previous steroid or radiation treatment except for emergency management started within one week before protocol therapy
- Pregnancy or lactation without agreement not to breastfeed
- Down syndrome
- Use of CYP3A4 substrates with narrow therapeutic indices (Cohort 2 only)
- Use of potent CYP3A4 inhibitors within 7 days prior to enrollment (Cohort 2 only)
- Use of potent CYP3A4 inducers within 12 days prior to enrollment (Cohort 2 only)
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of Alabama
Birmingham, Alabama, United States, 35223
Actively Recruiting
2
Children's Hospital Orange County
Orange, California, United States, 92968
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Helen De Vos
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
6
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
Research Team
A
Ana Xavier
CONTACT
L
Lauren Harrison
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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