Home › Trials › NCT05444712

Transplantation for patients with T-cell lymphoma who have achieved complete response

Transplantation After Complete Response In Patients With T-cell Lymphoma

Not applicable Interventional Hospices Civils de Lyon · NCT05444712

This study is testing whether a stem cell transplant can help adults with T-cell lymphoma who have responded well to chemotherapy feel better and live longer compared to just continuing with chemotherapy.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment204 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorHospices Civils de Lyon Academic / other
Drugs / interventionscyclophosphamide, prednisone
Locations48 sites (Amiens and 47 other locations)
Trial IDNCT05444712 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of autologous stem cell transplantation (ASCT) as a consolidation treatment for patients with peripheral T-cell lymphoma (PTCL) who have achieved a complete metabolic response after initial chemotherapy. The study aims to determine whether ASCT can improve outcomes compared to chemotherapy alone. Eligible participants include adults aged 18 to 70 with specific subtypes of PTCL, who meet certain health criteria. The trial will assess the safety and efficacy of the intervention through follow-up evaluations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed nodal-type peripheral T-cell lymphoma who have achieved a complete metabolic response after chemotherapy.

Not a fit: Patients with advanced-stage disease or those who have previously received treatment for PTCL may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates for patients with peripheral T-cell lymphoma.

How similar studies have performed: Other studies have shown promising results for autologous stem cell transplantation in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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) 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
4. Ann Arbor staging (I-IV) except stage I with normal LDH and PS\<2 (i.e. stage I aaIPI 0)
5. 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)
6. FFPE Diagnostic tissue block should be available for central pathology review and ancillary molecular analyses
7. Participant with Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
8. Estimated minimum life expectancy of 3 months
9. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
10. Able to adhere to the study visit schedule and other protocol requirements
11. Patient covered by any social security system (France)
12. Patient who understands and speaks one of the country official languages
13. 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
14. 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

Exclusion Criteria:

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:

   * Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
   * Extranodal T-cell/NK-cell lymphoma, nasal type
   * Anaplastic large cell lymphoma, ALK-positive type
   * Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome)
   * Primary cutaneous CD30+ T-cell lymphoproliferative disorder
   * Primary cutaneous anaplastic T-cell lymphoma
   * Enteropathy-associated T-cell lymphoma
   * Hepatosplenic T-cell lymphoma
   * Subcutaneous panniculitis-like T-cell lymphoma
   * Primary cutaneous gamma-delta T-cell lymphoma
   * Primary cutaneous CD8+ aggressive epidermotropic lymphoma
   * 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:

   1. Basal or squamous cell carcinoma of the skin
   2. Carcinoma in situ of the cervix
   3. Carcinoma in situ of the breast
   4. 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 (cyclophosphamide, vincristine, prednisone) in case of (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)

15\. 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 9. Pregnant, planning to become pregnant or lactating WOCBP 10. 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) 11. Person deprived of his/her liberty by a judicial or administrative decision 12. Person hospitalized without consent 13. Adult person under legal protection

Where this trial is running

Amiens and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peripheral T Cell Lymphomaperipheral T-cell Lymphomaautologous stem cell transplantationchemotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.