Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

Stopped early · Phase 2/Phase 3

Conditions studied: Myeloid Leukemia, Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Myeloproliferative Disorders

In brief

The purpose of this study is to determine whether the administration of a donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted stem cell transplant from a related, haploidentical donor enhances survival by improving the immune effect against infections while preventing graft-versus-host disease .

Key facts

Study ID

NCT00967343

Run by

Kiadis Pharma

People needed

40

Starts

2009-08-01

Expected to finish

2012-02-01

Last updated by the study team

2021-06-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• One of the following hematological malignancies:
• Acute Myeloid Leukemia (AML)
• Acute Lymphoblastic Leukemia (ALL)
• Myelodysplastic Syndrome (MDS)
• Ph-positive chronic myeloid leukemia (CML)
• Non-Hodgkin Lymphoma (NHL)
• Myelodysplastic Syndrome (MDS)
• Chronic Myeloid Leukemia (CML)
• Multiple Myeloma (MM)
• Chronic Lymphocytic Leukemia (CLL)
• Myeloproliferative Syndrome (MPS)

You may not qualify if…

• AML in 1st complete remission with good risk karyotypes
• MM featuring concurrent extramedullar disease or being non-responsive to prior therapy
• CML in blast crisis
• CLL concurrently transformed into high-grade lymphoma and failing to demonstrate at least partial remission
• NHL with concurrent bulky disease (≥ 5 cm)
• Diffusing Capacity for Carbon Monoxide (DLCO) < 40% predicted
• Left ventricular ejection fraction < 40%
• AST/SGOT > 2.5 x ULN
• Bilirubin > 1.5 x ULN
• Creatinine > 1.5 x ULN
• HIV positive
• Positive pregnancy test for women of childbearing age
• Prior haploidentical peripheral blood stem cell or cord blood transplantation
• Less than 2 years from a prior allogeneic stem cell transplantation
• Estimated probability of surviving less than three months
• Major anticipated illness or organ failure incompatible with survival from transplant
• Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible
• Known allergy to any of the components of ATIR
• Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study
• Donor Inclusion Criteria:
• Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or DR loci of the unshared haplotype.
• Male or female, age ≥ 16, ≤ 75 years.
• Donors must be fit to receive G-CSF and undergo apheresis (normal blood count, normotensive and no history of stroke).
• Donor must have Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
• Donor must provide written informed consent.

Where it is running

• Ohio State University, Comprehesive Cancer Center — Columbus, Ohio, United States
• Algemeen Ziekenhuis Sint-Jan — Bruges, Belgium
• Université Libre de Bruxelles - Institute Jules Bordet — Brussels, Belgium
• Universitair Ziekenhuis Gasthuisberg — Leuven, Belgium
• University of Liege - CHU Sart Tilman — Liège, Belgium
• HHSC, Henderson Hospital Site — Hamilton, Ontario, Canada
• Ontario Cancer Institute / Princess Margaret Hospital — Toronto, Ontario, Canada
• Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada
• Universitätsklinikum Freiburg, Medizinische UNI-Klinik — Freiburg im Breisgau, Germany
• Universitätsklinikums Schleswig-Holstein Campus Kiel — Kiel, Germany
• Universitätsklinikum Mainz — Mainz, Germany
• Universitätsklinikum Würzburg — Würzburg, Germany
• Perugia University — Perugia, Italy
• Academisch Ziekenhuis Maastricht — Maastricht, Netherlands
• Hammersmith Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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