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Early Phase 1RecruitingPriority 4 · Lower priorityNCT03719105

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

ClinicalTrials.gov

Plain-language summary

This Early Phase 1 trial is comparing different first-line treatment approaches for people newly diagnosed with anaplastic large cell lymphoma (ALCL). Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 6 US locations across multiple states.

Who can join (key eligibility)

  • Age 1 Year to 31 Years years
  • Newly diagnosed, not yet treated

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Methotrexate (DRUG): Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant. | pralatraxate, (DRUG): Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Ifosfamide (DRUG): Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Dexamethasone (DRUG): Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Etoposide (DRUG): Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | calaspargase pegol (DRUG): Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | cyclophosphamide (DRUG): Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Doxorubicin (DRUG): Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Prednisone (DRUG): Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Brentuximab Vedotin (DRUG): Patients will receive brentuximab vedotin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

Drugs / treatments
Methotrexate, pralatraxate,, Ifosfamide, Dexamethasone, Etoposide, calaspargase pegol, cyclophosphamide, Doxorubicin, Prednisone, Brentuximab Vedotin
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

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

NCT03719105

Phase: Early Phase 1 | Status: Recruiting | Priority: Lower

Plain-language summary

This Early Phase 1 trial is comparing different first-line treatment approaches for people newly diagnosed with anaplastic large cell lymphoma (ALCL). Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 6 US locations across multiple states.

Who can join

  • Age 1 Year to 31 Years years
  • Newly diagnosed, not yet treated

What's being tested

Methotrexate (DRUG): Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant. | pralatraxate, (DRUG): Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Ifosfamide (DRUG): Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Dexamethasone (DRUG): Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Etoposide (DRUG): Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | calaspargase pegol (DRUG): Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | cyclophosphamide (DRUG): Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Doxorubicin (DRUG): Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Prednisone (DRUG): Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant. | Brentuximab Vedotin (DRUG): Patients will receive brentuximab vedotin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.

Drugs / treatments: Methotrexate, pralatraxate,, Ifosfamide, Dexamethasone, Etoposide, calaspargase pegol, cyclophosphamide, Doxorubicin, Prednisone, Brentuximab Vedotin

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 40 patients

Primary endpoint: overall response rate

Ages: 1 Year to 31 Years

Start date: 2019-03-01 | Est. completion: 2028-12-31

Locations

6 US sites · 6 total

Alabama, California, Michigan, New York, Ohio

Contact

Ana Xavier | axavier@peds.uab.edu | (205) 638-6763

Sponsor: New York Medical College (OTHER)

Tags

ALCL · ENKTL · Newly diagnosed

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT03719105

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.