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Phase 2RecruitingPriority 4 · Lower priorityNCT03125642

Auto Stem Cell Transplant for Lymphoma Patients

ClinicalTrials.gov

Plain-language summary

This trial is testing high-dose chemotherapy followed by autologous stem cell transplant (using the patient's own stem cells) compared with observation for patients with various types of peripheral T-cell lymphoma (PTCL) 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. Patients are randomly assigned to different treatment groups. This trial is available at 1 location in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Lymphoma came back or did not respond to prior treatment
  • 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

Etoposide (DRUG): BEAM: 100 mg/m\^2 IV over 2 hours BID on Days -5, -4, -3, -2 \| CBV: 150 mg/m\^2 intravenously over 4 hours every 12 hours starting at 6 a.m. and 6 p.m. on Days -6, -5, -4 | BCNU (DRUG): BEAM \& CBV: 300 mg/m\^2 IV over over 2 hours on Day -6 | AraC (DRUG): BEAM: 100 mg/m\^2 IV over 1 hour BID on Days -5, -4, -3, -2 | Melphalan (DRUG): BEAM: 140 mg/m\^2 IV over 20 minutes on Day -1 | Peripheral blood stem cell transplantation (PROCEDURE): All Arms: Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF. | G-CSF (BIOLOGICAL): All patients should receive G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day +5 until the ANC is \>2500 x 10\^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm\^3 | Cyclophosphamide (DRUG): CBV: 1.5 gm/M\^2 over 2 hours at 10 a.m. on Days -6, -5, -4, -3 \| CY/TBI: 60 mg/kg IV over 2 hours on Days -7, -6 | Total Body Irradiation (RADIATION): CY/TBI: 165 cGy bid on Day -4, -3, -2, -1

  • Etoposide, BCNU, AraC, Melphalan, Peripheral blood stem cell transplantation, G-CSF, Cyclophosphamide, Total Body Irradiation

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

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TrialCompass — Clinical Trial Summary

Auto Stem Cell Transplant for Lymphoma Patients

NCT03125642

Phase: Phase 2 | Status: Recruiting | Priority: Lower

Plain-language summary

This trial is testing high-dose chemotherapy followed by autologous stem cell transplant (using the patient's own stem cells) compared with observation for patients with various types of peripheral T-cell lymphoma (PTCL) 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. Patients are randomly assigned to different treatment groups. This trial is available at 1 location in the United States. The trial is currently recruiting patients.

Who can join

  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

Etoposide (DRUG): BEAM: 100 mg/m\^2 IV over 2 hours BID on Days -5, -4, -3, -2 \| CBV: 150 mg/m\^2 intravenously over 4 hours every 12 hours starting at 6 a.m. and 6 p.m. on Days -6, -5, -4 | BCNU (DRUG): BEAM \& CBV: 300 mg/m\^2 IV over over 2 hours on Day -6 | AraC (DRUG): BEAM: 100 mg/m\^2 IV over 1 hour BID on Days -5, -4, -3, -2 | Melphalan (DRUG): BEAM: 140 mg/m\^2 IV over 20 minutes on Day -1 | Peripheral blood stem cell transplantation (PROCEDURE): All Arms: Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF. | G-CSF (BIOLOGICAL): All patients should receive G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day +5 until the ANC is \>2500 x 10\^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm\^3 | Cyclophosphamide (DRUG): CBV: 1.5 gm/M\^2 over 2 hours at 10 a.m. on Days -6, -5, -4, -3 \| CY/TBI: 60 mg/kg IV over 2 hours on Days -7, -6 | Total Body Irradiation (RADIATION): CY/TBI: 165 cGy bid on Day -4, -3, -2, -1

Drugs / treatments: Etoposide, BCNU, AraC, Melphalan, Peripheral blood stem cell transplantation, G-CSF, Cyclophosphamide, Total Body Irradiation

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 150 patients

Primary endpoint: Progression Free Survival Comparison

Ages: — to 75 Years

Start date: 2017-04-20 | Est. completion: 2027-04-30

Locations

1 US sites · 1 total

Minnesota

Contact

Timothy Krepski | tkrepsk1@fairview.org | 612-273-2800

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

Tags

All T-cell lymphomas · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT03125642

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