Blood cell study aims to predict transplant complications

NCT ID NCT02194868

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 57 people who had a stem cell transplant for blood cancer. Researchers wanted to see if certain immune cells (iNKT cells) could help predict the risk of graft-versus-host disease (GVHD), a serious side effect. They measured these cells in the blood and the transplant itself to create a tool for doctors.

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Study facts

What this study's own registry entry says, in plain language.

Participants

57 people

The number who actually took part.

Started

Feb 2016

Finished

Jan 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The eligible patients will be select by the responsible physicians from clinical teams involved in this study at their BMT staff. These physicians will propose the study to selected patients and provide the informed consent. Grafts and blood from donors of patients involved in this study will be provided by the different cell therapy departments related to the clinical groups. Peripheral blood from healthy donors will be obtained from volunteer donations to the "Etablissement Français du Sang" (EFS).

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Criteria for adults: * Allogeneic HSCT with peripheral blood stem cell (PBSC) graft * Patients transplanted in cytologic Complete Remission (CR) * HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor * \- Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity conditioning. Iv Busulfan doses between 6.4 mg/kg to 9.6 mg/kg or Fludarabine - TBI ≤ 8 Gy are accepted. ATG should be thymoglobuline at 5 mg/kg * Consent form signed by the patient * Consent form signed by the donor * Affiliated or beneficiary of a health insurance regimen 2. Criteria for pediatric patients: * Allogeneic HSCT with bone marrow grafts * Myeloablative conditioning (either TBI 12 Gy with Cyclophosphamide or iv Busulfan (12.8 mg/kg) and cyclophosphamide or Fludarabine - TBI \> 8 Gy)- HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor * Consent form signed by the parents * Consent form signed by the donor or his legal representative if it is minor * Beneficiary of a health insurance regimen Exclusion Criteria: * History of previous autologous or allogeneic haematopoietic stem cell transplantation * Disease non in cytologic CR at transplant * Other type of conditioning than Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity. * Donor graft with any HLA mismatch including haploidentical and cord blood grafts * Graft having one or more mismatch with the recipient HLA

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