Status:
TERMINATED
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
Lead Sponsor:
Kiadis Pharma
Conditions:
Myeloid Leukemia
Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 transpl...
Detailed Description
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significan...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
- Donor
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00967343
Start Date
August 1 2009
End Date
February 1 2012
Last Update
June 14 2021
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University, Comprehesive Cancer Center
Columbus, Ohio, United States, 43210
2
Algemeen Ziekenhuis Sint-Jan
Bruges, Belgium, 8000
3
Université Libre de Bruxelles - Institute Jules Bordet
Brussels, Belgium, 1000
4
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000