Transplantation After Complete Response In Patients With T-cell Lymphoma
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.
• Patient ≥ 18 years and \< 70 years of age at the time of signing the informed consent form (ICF)
• Patient fit enough to receive autologous stem cell transplant as a consolidation strategy as assessed by the local investigator
• Hemoglobin level \> 8g/dL (transfusion allowed); Neutrophil count \>0.5 G/L; Platelets count \> 50 G/L (transfusion allowed) Patient with histologically proven nodal-type peripheral T-cell lymphoma (PTCL) (latest WHO classification), not previously treated; as defined by the WHO classification, the following subtypes may be included,
‣ PTCL, not otherwise specified
⁃ Follicular helper T-cell lymphomas: Angioimmunoblastic T-cell lymphoma and nodal PTCL with TFH phenotype and follicular T-cell lymphoma
⁃ Anaplastic large cell lymphoma, ALK-negative
• Ann Arbor staging (I-IV) except stage I with normal LDH and PS\<2 (i.e. stage I aaIPI 0)
• Participant with a measurable disease by the Lugano criteria (i.e., longest diameter of a nodal site \> 1.5 cm and/or longest diameter of an extranodal site \> 1.0 cm and/or a hypermetabolic lesion)
• FFPE Diagnostic tissue block should be available for central pathology review and ancillary molecular analyses
• Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Estimated minimum life expectancy of 3 months
• Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
⁃ Able to adhere to the study visit schedule and other protocol requirements
⁃ Patient covered by any social security system (France)
⁃ Patient who understands and speaks one of the country official languages
⁃ Males with partners of childbearing potential must agree to use effective birth control methods during the study as informed by the investigator in accordance with SmPC of each drugs administrated
⁃ Females of childbearing potential must agree to use effective birth control methods for at least 28 days before starting treatment; while participating in the study; during treatment interruptions and necessary period after the study as informed by the investigator in accordance with SmPC of each drugs administrated