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NARecruitingPriority 4 · Lower priorityNCT05444712

Transplantation After Complete Response In Patients With T-cell Lymphoma

ClinicalTrials.gov

Plain-language summary

This NA trial is comparing different first-line treatment approaches for people newly diagnosed with a type of T-cell lymphoma called AITL. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years to 70 Years years
  • Newly diagnosed, not yet treated
  • 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

Chemotherapy + follow up (PROCEDURE): * Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients | Chemotherapy + ASCT + follow up (PROCEDURE): * Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * The fifth or sixth cycles should be used as stem-cell mobilizing chemotherapy for patients with ASCT strategy * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * Patients with in Complete Response after 6 cycles will receive a High Dose Therapy as conditioning regimen before transplantation * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients

Drugs / treatments
Chemotherapy + follow up, Chemotherapy + ASCT + follow up
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
NA
Status
Recruiting
Design
Randomized, open-label
Enrollment target
204 patients
Primary endpoint
to assess if ASCT is associated with a significant prolongation of progression-free survival (PFS) for patient with peripheral T-cell lymphoma (PTCL) reaching a complete response (CR) according to the response critter
Ages
18 Years to 70 Years
Start date
2022-08-01
Est. completion
2028-04-01

Locations

0 US sites · 48 total

No US sites currently listed.

Contact

Sponsor
Hospices Civils de Lyon (OTHER)
Contact
Emmanuel BACHY, Pr | emmanuel.bachy@chu-lyon.fr | +33(0) 4 78 86 22 05

Tags

AITL/TFHALCLENKTLPTCL-NOSMaintenanceNewly diagnosedRelapsed/Refractory
TrialCompass — Clinical Trial Summary

Transplantation After Complete Response In Patients With T-cell Lymphoma

NCT05444712

Phase: NA | Status: Recruiting | Priority: Lower

Plain-language summary

This NA trial is comparing different first-line treatment approaches for people newly diagnosed with a type of T-cell lymphoma called AITL. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 70 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

Chemotherapy + follow up (PROCEDURE): * Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients | Chemotherapy + ASCT + follow up (PROCEDURE): * Chemotherapy administrated every 3 weeks for 6 cycles according to local investigator's choice based on usual practices. * An intermediate evaluation will be performed after four cycles by PET-CT (or CT-Scan for non-avid PTCL) * The fifth or sixth cycles should be used as stem-cell mobilizing chemotherapy for patients with ASCT strategy * A post-induction evaluation by PET-CT or CT-Scan will be done between 3 and 5 weeks after the last chemotherapy drug administration for all patients * Patients with in Complete Response after 6 cycles will receive a High Dose Therapy as conditioning regimen before transplantation * A last evaluation by PET-CT or CT-Scan will be done between 08 and 12 weeks after the post-induction for all patients

Drugs / treatments: Chemotherapy + follow up, Chemotherapy + ASCT + follow up

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, open-label

Enrollment target: 204 patients

Primary endpoint: to assess if ASCT is associated with a significant prolongation of progression-free survival (PFS) for patient with peripheral T-cell lymphoma (PTCL) reaching a complete response (CR) according to the response critter

Ages: 18 Years to 70 Years

Start date: 2022-08-01 | Est. completion: 2028-04-01

Locations

0 US sites · 48 total

Contact

Emmanuel BACHY, Pr | emmanuel.bachy@chu-lyon.fr | +33(0) 4 78 86 22 05

Sponsor: Hospices Civils de Lyon (OTHER)

Tags

AITL/TFH · ALCL · ENKTL · PTCL-NOS · Maintenance · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05444712

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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