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Phase 2RecruitingPriority 2 · High priorityNCT05031897

Two Step Haplo With Radiation Conditioning

ClinicalTrials.gov

Plain-language summary

This Phase 2 trial is studying Fludarabine, Total-Body Irradiation, and other medications for people with adult T-cell leukemia/lymphoma. 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 18 Years or older
  • Must be well enough for treatment (adequate performance status)

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

What's being tested

Fludarabine (DRUG): Given IV | Total-Body Irradiation (RADIATION): Undergo TBI | Donor Lymphocyte Infusion (PROCEDURE): Undergo DLI | Cyclophosphamide (DRUG): Given IV | Tacrolimus (DRUG): Given IV | Mycophenolate Mofetil (DRUG): Given IV | Hematopoietic Cell Transplantation (PROCEDURE): Undergo HSCT | Melphalan (DRUG): Given IV | Bone Marrow Aspiration and Biopsy (PROCEDURE): Undergo bone marrow aspiration/ biopsy | Diagnostic Imaging (PROCEDURE): Undergo diagnostic imaging | Biospecimen Collection (PROCEDURE): Undergo blood sample collection

Drugs / treatments
Fludarabine, Total-Body Irradiation, Donor Lymphocyte Infusion, Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, Hematopoietic Cell Transplantation, Melphalan, Bone Marrow Aspiration and Biopsy, Diagnostic Imaging, Biospecimen Collection
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
63 patients
Primary endpoint
Number of Participants Who Experience Treatment-Related Mortality (TRM)
Ages
18 Years to —
Start date
2021-10-25
Est. completion
2032-04

Locations

1 US sites · 1 total

Pennsylvania

Contact

Sponsor
Thomas Jefferson University (OTHER)
Contact
Usama Gergis, MD | usama.gergis@jefferson.edu | 215-503-2455

Tags

ATLLany
TrialCompass — Clinical Trial Summary

Two Step Haplo With Radiation Conditioning

NCT05031897

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

Plain-language summary

This Phase 2 trial is studying Fludarabine, Total-Body Irradiation, and other medications for people with adult T-cell leukemia/lymphoma. 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 18 Years or older
  • Must be well enough for treatment (adequate performance status)

What's being tested

Fludarabine (DRUG): Given IV | Total-Body Irradiation (RADIATION): Undergo TBI | Donor Lymphocyte Infusion (PROCEDURE): Undergo DLI | Cyclophosphamide (DRUG): Given IV | Tacrolimus (DRUG): Given IV | Mycophenolate Mofetil (DRUG): Given IV | Hematopoietic Cell Transplantation (PROCEDURE): Undergo HSCT | Melphalan (DRUG): Given IV | Bone Marrow Aspiration and Biopsy (PROCEDURE): Undergo bone marrow aspiration/ biopsy | Diagnostic Imaging (PROCEDURE): Undergo diagnostic imaging | Biospecimen Collection (PROCEDURE): Undergo blood sample collection

Drugs / treatments: Fludarabine, Total-Body Irradiation, Donor Lymphocyte Infusion, Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, Hematopoietic Cell Transplantation, Melphalan, Bone Marrow Aspiration and Biopsy, Diagnostic Imaging, Biospecimen Collection

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 63 patients

Primary endpoint: Number of Participants Who Experience Treatment-Related Mortality (TRM)

Ages: 18 Years to —

Start date: 2021-10-25 | Est. completion: 2032-04

Locations

1 US sites · 1 total

Pennsylvania

Contact

Usama Gergis, MD | usama.gergis@jefferson.edu | 215-503-2455

Sponsor: Thomas Jefferson University (OTHER)

Tags

ATLL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05031897

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.

Built with care for the rare cancer community.

Data last updated: June 2026

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