Clinical trial · Interventional
Therapeutic Intensification of HIV-associated Non-Hodgkin's Lymphoma by Peripheral Blood Cell Transplantation Following Chemotherapy.
Therapeutic Intensification for HIV-associated Non-Hodgkin's Lymphoma by Autologous Transplantation of Either Unselected or CD34+-Selected Peripheral Blood Stem Cells, in Patients in First or Second Complete Remission. ANRS 131
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): only one patient enrolled
Summary
Brief summary (as posted)
Given the poor prognosis of HIV-associated non-Hodgkin's lymphoma (NHL) and it's still high incidence in HAART era, more intensive therapy is required in patients with initially severe stage of NHL or relapsing after first-line chemotherapy. The purpose of this study is to evaluate the safety of an intensive chemotherapy followed by peripheral blood cell transplantation in these patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous peripheral blood cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety criteria defined as the occurrence of grades 3 or 4 adverse events in the 6 months following transplantation.
Secondary outcomes (8)
- measure
- Evaluation of:
- measure
- HIV RNA
- measure
- HIV DNA
- measure
- Percentage and absolute count of CD3, CD4+ and CD8+ lymphocytes
- measure
- Lymphocyte phenotypes and functions
- measure
- TREC analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients between 18 and 55 years old at screening * Documented HIV-1 infection * Currently HAART-treated * Plasma HIV-RNA below 50 copies/ml at screening * Lymphocyte T CD4+ count above or equal to 100/mm3 at the NHL diagnosis * Histologically proven large cell NHL in first remission with classical poor prognostic factors (IPI above or equal to 2) or in second remission whatever IPI. * Biological criteria of eligibility for intensive therapeutic * Signed written informed consent * Patient protected by the social security of one of the European community countries. Exclusion Criteria: * Burkitt NHL * Central nervous system NHL * Patients already treated by ASCT * Ongoing infectious disease * Psychiatric disease * Left ventricular ejection fraction \< 25% * Creatinine clearance \< 50 ml/min * Hepatic failure * Uncontrolled high blood pressure * Chronic hepatitis C or B * Participating in other trials.
References
Publications (0)
Data not yet available