NCT05444712

Transplantation After Complete Response In Patients With T-cell Lymphoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL. The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Chemotherapy + follow up	* 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
PROCEDURE	Chemotherapy + ASCT + follow up	* 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

Timeline

• Start date: 2022-08-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2022-07-06
• Last updated: 2023-09-28

Locations

48 sites across 1 country: France