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RECRUITING Early Phase 1

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

NCT03719105 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Etoposide
  • DRUG Dexamethasone
  • DRUG Ifosfamide
  • DRUG Methotrexate
  • DRUG pralatraxate,

Study Locations (6)

California

  • Children's Hospital Orange County — Orange
  • University of California San Francisco — San Francisco

Alabama

  • University of Alabama — Birmingham

Michigan

  • Helen De Vos — Grand Rapids

New York

  • New York Medical College — Valhalla

Ohio

  • Nationwide Children's Hospital — Columbus

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-03-01
Est. Completion 2028-12-31
Phase Early Phase 1

Sponsor

New York Medical College

50 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03719105

The ClinicalTrials.gov registry entry for NCT03719105 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York Medical College, which has 50 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Peripheral T Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Etoposide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03719105 reports 6 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03719105 about?

NCT03719105 is a clinical study titled "Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma". 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) (Cyc...

What is the current status of trial NCT03719105?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2019-03-01. Estimated completion is 2028-12-31.

What conditions does trial NCT03719105 study?

This clinical trial studies the following conditions: Peripheral T Cell Lymphoma, NK-Cell Lymphoma, NK-Cell Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03719105?

The interventions under investigation include: Etoposide (DRUG), Dexamethasone (DRUG), Ifosfamide (DRUG), Methotrexate (DRUG), pralatraxate, (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03719105?

This trial is sponsored by New York Medical College, which has 50 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03719105 being conducted?

This trial has 6 study locations across Alabama, California, Michigan, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial