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Phase 2RecruitingPriority 2 · High priorityNCT04195633

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

ClinicalTrials.gov

Plain-language summary

This Phase 2 trial is comparing Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, and other medications against other options for people whose anaplastic large cell lymphoma (ALCL) has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 1 US location.

Who can join (key eligibility)

  • Age 6 Months or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

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

What's being tested

Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE): Undergo allogeneic hematopoietic stem cell transplantation | Cyclophosphamide (DRUG): Given IV | Cyclosporine (DRUG): Given IV or PO | Filgrastim (BIOLOGICAL): Given IV | Fludarabine (DRUG): Given IV | Mycophenolate Mofetil (DRUG): Given IV or PO | Mycophenolate Sodium (DRUG): Given PO | Total-Body Irradiation (RADIATION): Undergo total-body irradiation | Treosulfan (DRUG): Given IV | Bone Marrow Aspiration (PROCEDURE): Undergo bone marrow aspiration | Bone Marrow Biopsy (PROCEDURE): Undergo bone marrow biopsy | Echocardiography Test (PROCEDURE): Undergo echocardiography | Biospecimen Collection (PROCEDURE): Undergo blood sample collection | Computed Tomography (PROCEDURE): Undergo CT or PET/CT | Positron Emission Tomography (PROCEDURE): Undergo PET/CT

Drugs / treatments
Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Cyclosporine, Filgrastim, Fludarabine, Mycophenolate Mofetil, Mycophenolate Sodium, Total-Body Irradiation, Treosulfan, Bone Marrow Aspiration, Bone Marrow Biopsy, Echocardiography Test, Biospecimen Collection, Computed Tomography, Positron Emission Tomography
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 2
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
60 patients
Primary endpoint
Graft failure/rejection
Ages
6 Months to —
Start date
2021-01-25
Est. completion
2029-03-12

Locations

1 US sites · 1 total

Washington

Contact

Sponsor
Fred Hutchinson Cancer Center (OTHER)
Contact
Phuong Vo, MD | ptvo@fredhutch.org | 206-667-2749

Tags

ALCLRelapsed/Refractory
TrialCompass — Clinical Trial Summary

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

NCT04195633

Phase: Phase 2 | Status: Recruiting | Priority: High

Plain-language summary

This Phase 2 trial is comparing Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, and other medications against other options for people whose anaplastic large cell lymphoma (ALCL) has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 1 US location.

Who can join

  • Age 6 Months or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

What's being tested

Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE): Undergo allogeneic hematopoietic stem cell transplantation | Cyclophosphamide (DRUG): Given IV | Cyclosporine (DRUG): Given IV or PO | Filgrastim (BIOLOGICAL): Given IV | Fludarabine (DRUG): Given IV | Mycophenolate Mofetil (DRUG): Given IV or PO | Mycophenolate Sodium (DRUG): Given PO | Total-Body Irradiation (RADIATION): Undergo total-body irradiation | Treosulfan (DRUG): Given IV | Bone Marrow Aspiration (PROCEDURE): Undergo bone marrow aspiration | Bone Marrow Biopsy (PROCEDURE): Undergo bone marrow biopsy | Echocardiography Test (PROCEDURE): Undergo echocardiography | Biospecimen Collection (PROCEDURE): Undergo blood sample collection | Computed Tomography (PROCEDURE): Undergo CT or PET/CT | Positron Emission Tomography (PROCEDURE): Undergo PET/CT

Drugs / treatments: Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Cyclosporine, Filgrastim, Fludarabine, Mycophenolate Mofetil, Mycophenolate Sodium, Total-Body Irradiation, Treosulfan, Bone Marrow Aspiration, Bone Marrow Biopsy, Echocardiography Test, Biospecimen Collection, Computed Tomography, Positron Emission Tomography

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 60 patients

Primary endpoint: Graft failure/rejection

Ages: 6 Months to —

Start date: 2021-01-25 | Est. completion: 2029-03-12

Locations

1 US sites · 1 total

Washington

Contact

Phuong Vo, MD | ptvo@fredhutch.org | 206-667-2749

Sponsor: Fred Hutchinson Cancer Center (OTHER)

Tags

ALCL · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04195633

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

For informational purposes only. Not medical advice — always consult your healthcare team.

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Data last updated: June 2026

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