Benefit of transplantation after Complete Response In Patients with T-cell lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Lysarc

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

7 Jun 2023 → ongoing

Decision date (initial)

2023-04-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

LYSARC (for Belgium) · Institut National du Cancer - France - PHRC (for France)

External identifiers

EU CT number

2022-501710-62-02

ClinicalTrials.gov

NCT05444712

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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).

Secondary objectives 7

1. Comparison of chemotherapy regimens (CHOP/CHOEP/BV-CHP) + ASCT consolidation with chemotherapy regimens (CHOP/CHOEP/BV-CHP) alone in terms of :
2. Overall survival (OS)
3. Overall response rate (ORR) and complete response rate (CRR) at the end of ASCT (8-12 weeks after post-induction evaluation) according to the IWC (International Workshop Criteria) Lugano 2014 (PET-CT-based response for FDG-avid lymphomas or CT-based response if not)
4. Duration of Response (DoR)
5. Cost-Effectiveness Analysis (CEA)
6. Budget Impact Analysis (BIA)
7. Comparison of central imaging review and local review of metabolic response rate after C4, after induction and at the end of ASCT (8-12 weeks after post-induction evaluation) according to the IWC (International Workshop Criteria) Lugano 2014 (PET-CT-based response for FDG-avid lymphomas only).

Conditions and MedDRA coding

Peripheral T-cell lymphoma (PTCL)

Study design 2 periods

Regulatory references

Plan to share IPD

Yes

IPD plan description

All individual participant may be available Protocol can be shared but with LYSA members only Immediately after publication. No end date except regulatory period. With LYSA members and researchers whose project has been approved by the study Coordinating Investigator and by LYSA Scientific Committee For any analysis with the aim of research in Lymphoma field. Proposals should be submitted to the study Coordinating Investigator. If he agrees with the collaboration/sharing, the project should be presented to LYSA Scientific Committee. If the project is validated by LYSA Scientific Committee, a Data Transfer Agreement compliant with GDPR and French Data Protection laws should be signed. DTA includes data protection rules and responsibilities of each parties, data security and storing information

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. Patient ≥ 18 years and < 70 years of age at the time of signing the informed consent form (ICF)
2. Patient fit enough to receive autologous stem cell transplant as a consolidation strategy as assessed by the local investigator
3. Hemoglobin level > 8g/dL (transfusion allowed); Neutrophil count >0.5 G/L; Platelets count > 50 G/L (transfusion allowed)
4. 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
5. Ann Arbor staging (I-IV) except stage I with normal LDH and PS<2 (i.e. stage I aaIPI 0)
6. 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)
7. FFPE Diagnostic tissue block should be available for central pathology review and ancillary molecular analyses
8. Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
9. Estimated minimum life expectancy of 3 months
10. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
11. Able to adhere to the study visit schedule and other protocol requirements
12. Patient covered by any social security system
13. Patient who understands and speaks one of the country official languages
14. 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)
15. 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)

Exclusion criteria 14

1. Known central nervous system or meningeal involvement by lymphoma
2. 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.
3. 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
4. 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
5. Vaccinated with live, attenuated vaccines within 6 months of enrollment
6. Use of any standard or experimental anti-cancer drug therapy before the start of treatment except COP (cycloposphamide, vincristine, prednisone) in case of emergency (or high risk of tumor lysis syndrome) or etoposide for a maximum of 3 doses (at a maximum dose of 150mg/m2) for HLH (Hemophagocytic Lymphohistiocytosis).
7. A corticosteroids therapy > 1mg/kg lasting more than 14 days prior to Cycle 1 Day 1
8. Positive serology for Human Immunodeficiency Virus (HIV) and Human T-Lymphotrophic Virus (HTLV1)
9. Active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infections defined as: HBV : HBs Ag positive / HBs Ag negative, anti-HBs antibody positive and anti-HBc antibody positive with detectable viral DNA - HCV : Anti-VHC antibody positive with detectable viral RNA
10. Pregnant, planning to become pregnant or lactating WOCBP
11. 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)
12. Person deprived of his/her liberty by a judicial or administrative decision
13. Person hospitalized without consent
14. Adult person under legal protection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Modified progression-free survival (mPFS)

Secondary endpoints 4

1. Overall survival (OS)
2. Overall response rate (ORR) according to the IWC (International Workshop Criteria) Lugano 2014
3. Complete response rate (CRR) according to the IWC (International Workshop Criteria) Lugano 2014
4. Duration of Response (DoR)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Lysarc

Sponsor organisation

Lysarc

Address

2d Lyon Sud Batiment

City

Pierre Benite Cedex

Postcode

69495

Country

France

Scientific contact point

Organisation

Lysarc

Contact name

Project Management

Public contact point

Organisation

Lysarc

Contact name

Project Management

Locations

2 EU/EEA countries · 61 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications