Actively Recruiting
Pilot Study of Induction Chemoimmunotherapy Followed by Reduced Toxicity Conditioning and Allogeneic Stem Cell Transplant in Advanced Mature Non-anaplastic T-Cell or NK Lymphoma/Leukemia in Children, Adolescents, and Young Adults
Led by New York Medical College · Updated on 2025-08-08
40
Participants Needed
6
Research Sites
52 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
Researchers are evaluating the use of chemoimmunotherapy followed by allogeneic stem cell transplant in children, adolescents, and young adults with advanced stage mature non-anaplastic T-cell or NK lymphoma/leukemia. The study includes two groups based on diagnosis: one with advanced NK cell leukemia or nasal type lymphoma, and the other with advanced peripheral T-cell lymphoma. This early phase 1 trial aims to assess overall response rates at one year and event-free survival over two years. Patients in Cohort 1 receive a modified SMILE chemotherapy regimen including methotrexate, ifosfamide, dexamethasone, etoposide, and pegaspargase, with pembrolizumab added for those not in complete remission after two cycles. Cohort 2 receives cycles alternating pralatrexate and brentuximab vedotin combined with cyclophosphamide, doxorubicin, and prednisone. Both groups proceed to allogeneic stem cell transplant if a suitable donor is available and disease is not progressing. Participants are monitored through treatment cycles with evaluations of disease response to guide therapy adjustments. Researchers measure overall response rate at one year as the primary outcome, with event-free survival at two years as a secondary outcome. The study involves close monitoring of organ function, including liver, heart, and lung assessments, and continues until the end of 2028. The total duration varies by participant depending on treatment response and transplant availability.
CONDITIONS
Brief 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- or NK-cell neoplasms as specified for Cohort 1 or Cohort 2.
- 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 NOS, angioimmunoblastic T-cell lymphoma, or other mature T- and NK-cell neoplasms after discussion.
- Lymphoma patients must have stage III or IV disease.
- Adequate liver function with bilirubin ≤1.5 times upper limit of normal and ALT <3 times upper limit.
- Adequate cardiac function with shortening fraction ≥27% or ejection fraction ≥50%.
- Adequate pulmonary function with no dyspnea at rest and pulse oximetry >92% on room air unless due to lymphoma.
You will not qualify if you...
- Diagnosis of Alk+ or Alk- Anaplastic Large Cell Lymphoma.
- Active central nervous system disease.
- Stage I or II disease.
- Prior cytotoxic chemotherapy for current lymphoma diagnosis.
- Previous steroid or radiation treatment except for emergency use started less than one week before protocol therapy.
- Pregnancy or lactation without agreement to avoid breastfeeding.
- Diagnosis of Down syndrome.
- For Cohort 2, chronic use of CYP3A4 substrates with narrow therapeutic indices, CYP3A4 inhibitors within 7 days, or CYP3A4 inducers within 12 days prior to enrollment (topical use allowed).
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable, depending on response and transplant availability
Participants receive chemoimmunotherapy regimens followed by an allogeneic stem cell transplant if a donor is available and the disease is not progressing.
Multiple visits for chemotherapy cycles and transplant procedures
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
L
Lauren Harrison
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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