2022-501710-62-02
Recruiting
Phase 4
TRANSCRIPT: An open label, controlled, randomized multicentric international study evaluating the benefit of autologous stem cell transplantation after complete response in frontline setting patients with T cell-lymphoma
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Lysarc
- Enrollment
- 204
- Locations
- 56
- Primary Endpoint
- Modified progression-free survival (mPFS)
Overview
Brief Summary
The principal objective of the study is to assess if autologous stem cell transplantation (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 criteria for lymphoma – Lugano 2014 after 6 cycles of induction chemotherapy (PET-CT-based response for FDG-avid lymphomas or CT-based response if not).
Study Design
- Allocation
- Randomized
- Primary Purpose
- Follow-up
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient ≥ 18 years and < 70 years of age at the time of signing the informed consent form (ICF)
- •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
- •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 and: for 6 months after last treatments administration (i.e. drugs administered according to the standard of care in the context of protocol)
- •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 for 12 months after last treatments administration (i.e. drugs administered according to the standard of care in the context of protocol)
- •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, o PTCL, not otherwise specified o Follicular helper T-cell lymphomas: Angioimmunoblastic T-cell lymphoma and nodal PTCL with TFH phenotype and follicular T-cell lymphoma o Anaplastic large cell lymphoma, ALK-negative
Exclusion Criteria
- •Known central nervous system or meningeal involvement by lymphoma
- •Pregnant, planning to become pregnant or lactating WOCBP
- •Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with the participation in this clinical study (according to the investigator’s decision)
- •Person deprived of his/her liberty by a judicial or administrative decision
- •Person hospitalized without consent
- •Adult person under legal protection
- •Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (serum total bilirubin level > 2.0 mg/dl [34 µmol/L] (except in case of Gilbert’s Syndrome, or documented liver or pancreatic involvement by lymphoma), serum transaminases (AST or ALT) > 3 upper normal limit unless they are related to the lymphoma.
- •The following types of T-cell lymphomas: o Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma) o Extranodal T-cell/NK-cell lymphoma, nasal type o Anaplastic large cell lymphoma, ALK-positive type o Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome) o Primary cutaneous CD30+ T-cell lymphoproliferative disorder o Primary cutaneous anaplastic T-cell lymphoma o Enteropathy-associated T-cell lymphoma o Hepatosplenic T-cell lymphoma o Subcutaneous panniculitis-like T-cell lymphoma o Primary cutaneous gamma-delta T-cell lymphoma o Primary cutaneous CD8+ aggressive epidermotropic lymphoma o Primary cutaneous CD4+ small/medium T-cell lymphoma
- •Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease for ≥ 2 years. However, patients with the following history are allowed: a. Basal or squamous cell carcinoma of the skin b. Carcinoma in situ of the cervix c. Carcinoma in situ of the breast d. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis clinical staging system
- •Vaccinated with live, attenuated vaccines within 6 months of enrollment
Outcomes
Primary Outcomes
Modified progression-free survival (mPFS)
Modified progression-free survival (mPFS)
Secondary Outcomes
- Overall survival (OS)
- Overall response rate (ORR) according to the IWC (International Workshop Criteria) Lugano 2014
- Complete response rate (CRR) according to the IWC (International Workshop Criteria) Lugano 2014
- Duration of Response (DoR)
Investigators
Project Management
Scientific
Lysarc
Study Sites (56)
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