Clinical trial · Interventional
Amplifying Graft-Versus-Tumor Effect by Donor Regulatory T-Cell Depletion Before Donor Lymphocytes Infusion
Amplifying Graft-versus-tumor Effect by Donor Regulatory T-cell Depletion Before Donor Lymphocytes Infusion: a Phase I/II Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after allogeneic hematopoietic stem cell transplantation (HSCT) in mice. The investigators thus propose a clinical trial to test whether Treg-depleted donor lymphocytes infusion (dDLI) could induce an improved graft-versus-tumor (GVT) effect in patients refractory to standard DLI (stdDLI) for treatment of relapse after HSCT.
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 |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| donor lymphocyte infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 1
- interventionNames
- Procedure: donor lymphocyte infusion
Primary outcomes (1)
- measure
- Incidence of "severe" GHVD (grade >II) following dDLI should be inferior to 40%.
- timeFrame
- 4 weeks after dDLI
Secondary outcomes (3)
- measure
- The incidence of GVHD of any grade after dDLI
- timeFrame
- during the 12 months
- measure
- The anti-tumoral efficiency of dDLI to treat the relapse of the hematological malignancy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Hematological malignancy except chronic myeloid leukaemia. * Previous allogeneic hematopoietic stem cell transplantation. * Relapse diagnosed at the molecular, cytogenetic, or cytological level. * Failure of a previous stdILD or inclusion in first intention if progressive disease. * Age \> 18 years and \< 70 years at the time of inclusion. * Performance status considered on the score ECOG \< 2. * Life expectation 1-month-old superior. * Signed written informed consent. * Negative HCG in the 7 days preceding the inclusion for women in age of procreation. * Membership of the French national insurance. Exclusion Criteria: * Chronic myeloid leukemia * Grade \>II acute GVHD or chronic extensive GVHD at the time of inclusion. * Patient receiving an immunosuppressive treatment for GVHD treatment at the time of inclusion. * Dysfunction of liver (ALAT/ASAT \> 5 N, or bilirubin \> 50 µM), or of the renal function (creatinine clearance \< 30 ml / min).
References
Publications (1)
- RESULTMaury S, Lemoine FM, Hicheri Y, Rosenzwajg M, Badoual C, Cherai M, Beaumont JL, Azar N, Dhedin N, Sirvent A, Buzyn A, Rubio MT, Vigouroux S, Montagne O, Bories D, Roudot-Thoraval F, Vernant JP, Cordonnier C, Klatzmann D, Cohen JL. CD4+CD25+ regulatory T cell depletion improves the graft-versus-tumor effect of donor lymphocytes after allogeneic hematopoietic stem cell transplantation. Sci Transl Med. 2010 Jul 21;2(41):41ra52. doi: 10.1126/scitranslmed.3001302. PMID 20650872