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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: Recruiting Early Phase 1 study of Peripheral T-Cell Lymphoma and NK-Cell Lymphoma, sponsored by New York Medical College.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
to assess overall response rate following chemoimmunotherapy induction therapy
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2028-12-31 |
| Phase | Early Phase 1 |
What NCT03719105 shows while recruiting
NCT03719105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 105-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (62% lower).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
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Where NCT03719105's enrollment target sits among peer trials
40 20th of 34 higher than 15 of 34 other Peripheral T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral T-Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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