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Phase 2RecruitingPriority 2 · High priorityNCT05805605

Allo HSCT Using RIC and PTCy for Hematological Diseases

ClinicalTrials.gov

Plain-language summary

This trial is testing allogeneic stem cell transplant (from a donor) for patients with T-cell prolymphocytic leukemia (T-PLL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 2 trial, which means researchers are studying how well the treatment works and monitoring for side effects. Researchers want to learn whether this approach can help control the lymphoma. This trial is available at 1 location in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Newly diagnosed, not yet treated
  • See full trial listing for complete eligibility

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

What's being tested

Peripheral Blood Stem Cell Transplant (BIOLOGICAL): On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused. | Allopurinol 300 MG (DRUG): 300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants. | Fludarabine (DRUG): 30 mg/m2 IV over 1 hour. Administered on day -6 to day -2. | Cyclophosphamide (DRUG): Administered as a 2 hour IV infusion on day -6, +3, and +4. | Bone Marrow Cell Transplant (BIOLOGICAL): On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused. | Total Body Irradiation (RADIATION): The dose of TBI will be 200 cGy given in a single fraction on day -1. | Sirolimus Pill (DRUG): All participants begin +5 to day +60. Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg). Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg). | Mycophenolate Mofetil (DRUG): All patients begin day +5 through day +35. 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.

  • Peripheral Blood Stem Cell Transplant, Allopurinol 300 MG, Fludarabine, Cyclophosphamide, Bone Marrow Cell Transplant, Total Body Irradiation, Sirolimus Pill, Mycophenolate Mofetil

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

Learn more

What is T-PLL?

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TrialCompass — Clinical Trial Summary

Allo HSCT Using RIC and PTCy for Hematological Diseases

NCT05805605

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

Plain-language summary

This trial is testing allogeneic stem cell transplant (from a donor) for patients with T-cell prolymphocytic leukemia (T-PLL) who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 2 trial, which means researchers are studying how well the treatment works and monitoring for side effects. Researchers want to learn whether this approach can help control the lymphoma. This trial is available at 1 location in the United States. The trial is currently recruiting patients.

Who can join

  • Newly diagnosed, not yet treated
  • See full trial listing for complete eligibility

What's being tested

Peripheral Blood Stem Cell Transplant (BIOLOGICAL): On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused. | Allopurinol 300 MG (DRUG): 300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants. | Fludarabine (DRUG): 30 mg/m2 IV over 1 hour. Administered on day -6 to day -2. | Cyclophosphamide (DRUG): Administered as a 2 hour IV infusion on day -6, +3, and +4. | Bone Marrow Cell Transplant (BIOLOGICAL): On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused. | Total Body Irradiation (RADIATION): The dose of TBI will be 200 cGy given in a single fraction on day -1. | Sirolimus Pill (DRUG): All participants begin +5 to day +60. Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg). Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg). | Mycophenolate Mofetil (DRUG): All patients begin day +5 through day +35. 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.

Drugs / treatments: Peripheral Blood Stem Cell Transplant, Allopurinol 300 MG, Fludarabine, Cyclophosphamide, Bone Marrow Cell Transplant, Total Body Irradiation, Sirolimus Pill, Mycophenolate Mofetil

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 56 patients

Primary endpoint: Evaluate rates of acute graft-versus-host disease (GVHD); Evaluate rates of chronic graft-versus-host disease (GVHD)

Ages: — to 75 Years

Start date: 2023-05-01 | Est. completion: 2028-10-22

Locations

1 US sites · 1 total

Minnesota

Contact

Mark Juckett | juck0001@umn.edu | 6126255469

Sponsor: Masonic Cancer Center, University of Minnesota (OTHER)

Tags

T-PLL · Maintenance · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05805605

Prepared using TrialCompass (trialcompass.com) on August 2, 2026. For informational purposes only. Always discuss with your healthcare team.