EUCTR2015-002821-20-DE
Active, not recruiting
Phase 1
An exploratory, open-label, multicenter study to evaluate the safety and efficacy of a two-dose regimen of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kiadis Pharma Netherlands B.V.
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any of the following hematologic malignancies:
- •\- Acute myeloid leukemia (AML) in first remission with high\-risk features or in second or higher remission
- •\- Acute lymphoblastic leukemia (ALL) in first remission with high\-risk features or in second or higher remission
- •\- Myelodysplastic syndrome (MDS): transfusion\-dependent, or intermediate or higher IPSS\-R risk group
- •Karnofsky performance status \= 70%
- •Eligible for haploidentical stem cell transplantation according to the investigator
- •Male or female, age \= 18 years and \= 65 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Availability of a fully matched related or unrelated donor following a donor search
- •Diffusing capacity for carbon monoxide (DLCO) \< 50% predicted
- •Left ventricular ejection fraction \< 50% (evaluated by echocardiogram or MUGA)
- •AST \> 2\.5 x ULN (CTCAE grade 2\)
- •Bilirubin \> 1\.5 x ULN (CTCAE grade 2\)
- •Creatinine clearance \< 50 mL/min (calculated or measured)
- •Positive HIV test
- •Positive pregnancy test (women of childbearing age only)
- •Prior allogeneic HSCT
- •Estimated probability of surviving less than 3 months
Outcomes
Primary Outcomes
Not specified
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Safety and efficacy of two doses of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted of host alloreactive T-cells, in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0 Level: PT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2015-002821-20-BEKiadis Pharma Netherlands B.V.20
Active, not recruiting
Phase 1
Safety and efficacy of donor T-lymphocytes depleted ex vivo of host alloreactive T-cells (ATIR) in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 19.1Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10027703Term: Mismatched donor bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2012-004461-41-DEKiadis Pharma Netherlands B.V.30
Active, not recruiting
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