Amplifying Graft-Versus-Tumor Effect by Donor Regulatory T-Cell Depletion Before Donor Lymphocytes Infusion (ILD-Treg)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00987987 |
Recruitment Status
:
Completed
First Posted
: October 1, 2009
Last Update Posted
: January 24, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hematologic Neoplasms Relapse | Procedure: donor lymphocyte infusion | Phase 1 Phase 2 |
We 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. We 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.
dDLI is administered after failure of 1 or several previous stdDLI of at least 107 CD3+ cells/kg, defined after a minimal follow-up of 2 months after the last injection. The absence of previous clinical manifestations of GVHD is required to be included. To prepare dDLI, CD25+ Treg are depleted from donor leukaphereses using anti-CD25 magnetic microbeads and a CliniMACS device (MYLTENYI). In order to evidence the potential effect of dDLI, the dDLI cell dose is adjusted to be below or equal to the maximal cell dose previously received in stdDLI. No comparison is planned in the analysis.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Amplifying Graft-versus-tumor Effect by Donor Regulatory T-cell Depletion Before Donor Lymphocytes Infusion: a Phase I/II Clinical Study |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
1
|
Procedure: donor lymphocyte infusion
regulatory T cells depletion
Other Name: regulatory T cells depletion
|
- Incidence of "severe" GHVD (grade >II) following dDLI should be inferior to 40%. [ Time Frame: 4 weeks after dDLI ]
- The incidence of GVHD of any grade after dDLI [ Time Frame: during the 12 months ]
- The anti-tumoral efficiency of dDLI to treat the relapse of the hematological malignancy [ Time Frame: during the 12 months ]
- The survival and the survival without disease after dDLI [ Time Frame: during the 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987987
France | |
Hopital Henri Mondor | |
Créteil, France, 94000 |
Principal Investigator: | Sébastien Maury, MD Ph | Assistance Publique - Hôpitaux de Paris |
Publications of Results:
Responsible Party: | Valérie Millul, Department Clinical Research of Developpement |
ClinicalTrials.gov Identifier: | NCT00987987 History of Changes |
Other Study ID Numbers: |
P040441 |
First Posted: | October 1, 2009 Key Record Dates |
Last Update Posted: | January 24, 2011 |
Last Verified: | September 2009 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
hematological malignancy allogeneic hematopoietic stem cell transplantation donor lymphocyte infusion antitumor immunotherapy |
graft-versus-tumor effect regulatory T cells adult |
Additional relevant MeSH terms:
Hematologic Neoplasms Neoplasms by Site Neoplasms Hematologic Diseases |