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NCT03719105 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Peripheral T-Cell Lymphoma and NK-Cell Lymphoma, sponsored by New York Medical College.

Recruiting
Registry status
Early Phase 1
Development phase
40
Enrollment target
6
Study locations

NCT03719105 is a Early Phase 1 study of Peripheral T-Cell Lymphoma and NK-Cell Lymphoma that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 40 participants, below the 105-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (62% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT03719105, a Early Phase 1 study of Peripheral T-Cell Lymphoma and NK-Cell Lymphoma, is actively recruiting participants, sponsored by New York Medical College.

RECRUITING
Registry status
Early Phase 1
Development phase
40 participants
Enrollment target
6
Study locations

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.

Conditions Studied

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

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

47 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, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 105-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (62% lower). The listed sponsor is New York Medical College, which has 47 total studies on file at ClinicalTrials.gov.

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.

NCT03719105 reports 6 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Michigan.

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.

What interventions are being tested in trial NCT03719105?

The interventions under investigation include: Etoposide (DRUG), Dexamethasone (DRUG), Ifosfamide (DRUG), Methotrexate (DRUG), pralatraxate, (DRUG).

Who is sponsoring clinical trial NCT03719105?

This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.