At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 and <70 years
- ✓Fit for autologous stem cell transplant
- ✓Histologically proven nodal-type PTCL not previously treated
- ✓Specified PTCL subtypes: PTCL-NOS, TFH-type lymphomas, ALK-negative ALCL
- ✕CNS or meningeal involvement
- ✕Impaired renal function (MDRD or Cockcroft-Gault <30 ml/min)
- ✕Impaired liver function: bilirubin >2.0 mg/dL or transaminases >3 ULN (unless lymphoma-related)
- ✕Excluded PTCL subtypes: ATLL, extranodal NK/T-cell nasal, ALK+ ALCL, cutaneous T-cell lymphomas, enteropathy-associated, hepatosplenic, subcutaneous panniculitis-like, gamma-delta, CD8+ aggressive epidermotropic, CD4+ small/medium
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Transplantation After Complete Response In Patients With T-cell Lymphoma
In Brief
A clinical study evaluating Chemotherapy + follow up and Chemotherapy + ASCT + follow up for Peripheral T Cell Lymphoma. Currently recruiting, targeting 204 participants across 48 sites.
Detailed 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.
Study Details
Timeline
Interventions
* 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 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